Limited Use — Reason for Use code 383 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 383 required
Write on scriptLU code 383 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 383
Reason for Use code 383
For use in combination with moisturizers or oral antihistamines in patients with atopic dermatitis who have failed or are intolerant to an 8 week trial of an intermediate potency topical steroid.
Coverage limit:
Therapy should be reassessed at 6 months.
Coverage limit:
LU Authorization Period: 1 year
No interchangeable product listed in the Ontario extract
Protopic · DIN 02244149
Manufacturer: Leo Pharma Inc.; listing date 2004-04-06
Health Canada: Marketed since 2017-05-25 · brand PROTOPIC · ATC D11AH01 TACROLIMUS · form Ointment · route Topical · ingredients TACROLIMUS 0.03 %/W/W · company Leo pharma inc · schedule Prescription
Protopic: Formulary list price $3.4301/unit (unit not stated in source; not the patient's cost)
Ministry pays: $3.4301 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=68110 · Verify on the e-Formulary ↗ (DIN 02244149)
Source record
DIN 02244149: Protopic
Raw flags: sec12=Y, sec3=Y
Item: 920000411; group id 965; item number 2293; lccId 00153; manufacturer id LEO
Source form: Oint; strength: 0.03%
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $3.4301; ministry $3.4301
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02244149
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=68110
Shortage status: discontinued (2025-04-15, reported by LEO PHARMA INC); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02244149
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Protopic · DIN 02244148 · 0.1% · Oint
Limited Use — Reason for Use code 383 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 383 required
Write on scriptLU code 383 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 383
Reason for Use code 383
For use in combination with moisturizers or oral antihistamines in patients with atopic dermatitis who have failed or are intolerant to an 8 week trial of an intermediate potency topical steroid.
Coverage limit:
Therapy should be reassessed at 6 months.
Coverage limit:
LU Authorization Period: 1 year
No interchangeable product listed in the Ontario extract
Protopic · DIN 02244148
Manufacturer: Leo Pharma Inc.; listing date 2004-04-06
Health Canada: Marketed since 2017-05-25 · brand PROTOPIC · ATC D11AH01 TACROLIMUS · form Ointment · route Topical · ingredients TACROLIMUS 0.1 %/W/W · company Leo pharma inc · schedule Prescription
Protopic: Formulary list price $3.6691/unit (unit not stated in source; not the patient's cost)
Ministry pays: $3.6691 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=68109 · Verify on the e-Formulary ↗ (DIN 02244148)
Source record
DIN 02244148: Protopic
Raw flags: sec12=Y, sec3=Y
Item: 920000402; group id 965; item number 2294; lccId 00153; manufacturer id LEO
Source form: Oint; strength: 0.1%
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $3.6691; ministry $3.6691
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02244148
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=68109
Shortage status: discontinued (2025-04-15, reported by LEO PHARMA INC); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02244148
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Ach-Tacrolimus · DIN 02454068 · 0.5mg · capsule
Limited Use — Reason for Use code 173 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 173 required
Write on scriptLU code 173 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 173
Reason for Use code 173
For solid organ transplant and bone marrow transplant.
Coverage limit:
LU Authorization Period: Indefinite
Brand vs generic price
Lowest DBP recovery rule under medically necessary no-substitution claims:
6.2 Medically Necessary "No Substitution" Claims
The Side Effect Reporting Form will not have to be renewed. However, the
pharmacy must maintain a copy of the prescription that contains a direction that
there be no substitution and the required Health Canada Side Effect Reporting Form
(completed and signed by the prescriber). The prescriber must write “No
Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and
indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will
be reimbursed the DBP plus a mark-up and the lesser of the posted usual and
customary fee or the ODB dispensing fee minus the applicable ODB co-payment
amount. Where a completed Side Effect Reporting Form is not available at the
pharmacy during an inspection, the difference between the cost of the higher-cost
product and the lowest DBP listed for the interchangeable category will be
recovered.
(ontario.ca, Revision #17; 2026-08-03 ↗)
6.2 Medically Necessary "No Substitution" Claims
The Ministry will provide reimbursement of a higher-cost interchangeable product in
medically necessary circumstances where a patient has experienced a significant
adverse reaction with two (2) lower-cost interchangeable drug products, where
available. When a prescriber identifies a patient for which it is medically necessary
that a higher cost interchangeable product be provided, the prescriber must:
• Complete, sign and forward to the pharmacist a copy of the Health Canada
side effect reporting form for each lower-cost interchangeable drug product
trialed (Side Effect Reporting Form[s]); and
• Write “No Substitution” or “No Sub” on a written prescription or indicate “No
Substitution” to the pharmacist in the case of a verbal prescription.
The prescriber should keep a copy of the completed form in the patient’s record for
future use and reference.
In the case of a written prescription, when the pharmacist or dispensing physician
receives a prescription with the written notation “No Substitution” or “No Sub”,
reimbursement will be provided for the higher-cost interchangeable product only if
the prescription is accompanied by a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed.
This form must be completely filled out noting the details of the adverse reaction
and signed by the prescriber.
In the case of a verbal prescription, the prescriber must satisfy the operator of the
pharmacy or dispensing physician that a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed
has been completed and signed by the prescriber. A written record of this verbal
prescription and the completed Health Canada Side Effect Reporting Form must be
received by the pharmacy prior to claim submission.
Upon receipt, the pharmacist must:
• Fax, submit online or mail the completed and signed form to Health Canada’s
Canada Vigilance Program; and
• Retain his or her copy of the completed and signed Side Effect Reporting
Form.
(ontario.ca, Revision #17; 2026-08-03 ↗)
1 brand, same coverage
Ach-Tacrolimus · DIN 02454068
Manufacturer: Accord Healthcare Inc.; listing date 2023-11-30
Health Canada: Marketed since 2023-09-21 · brand ACH-TACROLIMUS · ATC L04AD02 TACROLIMUS · form Capsule (immediate-release) · route Oral · ingredients TACROLIMUS 0.5 MG · company Accord healthcare inc · schedule Prescription
Ach-Tacrolimus: Formulary list price $1.0146/unit (unit not stated in source; not the patient's cost)
Ministry pays: $1.0146 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=94058 · Verify on the e-Formulary ↗ (DIN 02454068)
Source record
DIN 02454068: Ach-Tacrolimus
Raw flags: sec12=Y, sec3=Y
Item: 920000391; group id 963; item number 2286; lccId 00137; manufacturer id ACH
Source form: Cap; strength: 0.5mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $1.0146; ministry $1.0146
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02454068
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=94058Interchangeable products
Prograf · DIN 02243144 · $1.0146
Sandoz Tacrolimus · DIN 02416816 · $1.0146
Shortage status: resolved shortage (ended 2026-07-09); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02454068
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Prograf · DIN 02243144 · 0.5mg · capsule
Limited Use — Reason for Use code 173 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 173 required
Write on scriptLU code 173 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 173
Reason for Use code 173
For solid organ transplant and bone marrow transplant.
Coverage limit:
LU Authorization Period: Indefinite
Savings card: innoviCares lists Prograf (Ontario list dated 2026-09-10) — pays part of the brand-versus-generic difference after other coverage; free sign-up. (innovicares.ca ↗)
1 brand, same coverage
Prograf · DIN 02243144
Manufacturer: Astellas Pharma Canada Inc.; listing date 2009-04-01
Health Canada: Marketed since 2005-11-07 · brand PROGRAF · ATC L04AD02 TACROLIMUS · form Capsule · route Oral · ingredients TACROLIMUS 0.5 MG · company Astellas pharma canada inc · schedule Prescription
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=67015 · Verify on the e-Formulary ↗ (DIN 02243144)
Source record
DIN 02243144: Prograf
Raw flags: sec12=Y, sec3=Y
Item: 920000391; group id 963; item number 2286; lccId 00137; manufacturer id ASE
Source form: Cap; strength: 0.5mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $2.0291; ministry $1.0146
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02243144
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=67015Interchangeable products
Ach-Tacrolimus · DIN 02454068 · $1.0146
Sandoz Tacrolimus · DIN 02416816 · $1.0146
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02243144
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Sandoz Tacrolimus · DIN 02416816 · 0.5mg · capsule
Limited Use — Reason for Use code 173 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 173 required
Write on scriptLU code 173 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 173
Reason for Use code 173
For solid organ transplant and bone marrow transplant.
Coverage limit:
LU Authorization Period: Indefinite
Brand vs generic price
Lowest DBP recovery rule under medically necessary no-substitution claims:
6.2 Medically Necessary "No Substitution" Claims
The Side Effect Reporting Form will not have to be renewed. However, the
pharmacy must maintain a copy of the prescription that contains a direction that
there be no substitution and the required Health Canada Side Effect Reporting Form
(completed and signed by the prescriber). The prescriber must write “No
Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and
indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will
be reimbursed the DBP plus a mark-up and the lesser of the posted usual and
customary fee or the ODB dispensing fee minus the applicable ODB co-payment
amount. Where a completed Side Effect Reporting Form is not available at the
pharmacy during an inspection, the difference between the cost of the higher-cost
product and the lowest DBP listed for the interchangeable category will be
recovered.
(ontario.ca, Revision #17; 2026-08-03 ↗)
6.2 Medically Necessary "No Substitution" Claims
The Ministry will provide reimbursement of a higher-cost interchangeable product in
medically necessary circumstances where a patient has experienced a significant
adverse reaction with two (2) lower-cost interchangeable drug products, where
available. When a prescriber identifies a patient for which it is medically necessary
that a higher cost interchangeable product be provided, the prescriber must:
• Complete, sign and forward to the pharmacist a copy of the Health Canada
side effect reporting form for each lower-cost interchangeable drug product
trialed (Side Effect Reporting Form[s]); and
• Write “No Substitution” or “No Sub” on a written prescription or indicate “No
Substitution” to the pharmacist in the case of a verbal prescription.
The prescriber should keep a copy of the completed form in the patient’s record for
future use and reference.
In the case of a written prescription, when the pharmacist or dispensing physician
receives a prescription with the written notation “No Substitution” or “No Sub”,
reimbursement will be provided for the higher-cost interchangeable product only if
the prescription is accompanied by a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed.
This form must be completely filled out noting the details of the adverse reaction
and signed by the prescriber.
In the case of a verbal prescription, the prescriber must satisfy the operator of the
pharmacy or dispensing physician that a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed
has been completed and signed by the prescriber. A written record of this verbal
prescription and the completed Health Canada Side Effect Reporting Form must be
received by the pharmacy prior to claim submission.
Upon receipt, the pharmacist must:
• Fax, submit online or mail the completed and signed form to Health Canada’s
Canada Vigilance Program; and
• Retain his or her copy of the completed and signed Side Effect Reporting
Form.
(ontario.ca, Revision #17; 2026-08-03 ↗)
1 brand, same coverage
Sandoz Tacrolimus · DIN 02416816
Manufacturer: Sandoz Canada Inc.; listing date 2015-01-28
Health Canada: Marketed since 2014-06-11 · brand SANDOZ TACROLIMUS · ATC L04AD02 TACROLIMUS · form Capsule (immediate-release) · route Oral · ingredients TACROLIMUS (TACROLIMUS MONOHYDRATE) 0.5 MG · company Sandoz canada incorporated · schedule Prescription
Sandoz Tacrolimus: Formulary list price $1.0146/unit (unit not stated in source; not the patient's cost)
Ministry pays: $1.0146 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=90142 · Verify on the e-Formulary ↗ (DIN 02416816)
Source record
DIN 02416816: Sandoz Tacrolimus
Raw flags: sec12=Y, sec3=Y
Item: 920000391; group id 963; item number 2286; lccId 00137; manufacturer id SDZ
Source form: Cap; strength: 0.5mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $1.0146; ministry $1.0146
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02416816
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=90142Interchangeable products
Ach-Tacrolimus · DIN 02454068 · $1.0146
Prograf · DIN 02243144 · $1.0146
Shortage status: resolved shortage (ended 2023-10-30); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02416816
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Advagraf · DIN 02296462 · 0.5mg · extended release capsule
Limited Use — Reason for Use code 410 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 410 required
Write on scriptLU code 410 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 410
Reason for Use code 410
For prophylaxis of organ rejection in adult patients receiving allogeneic kidney transplants
Coverage limit:
LU Authorization Period: Indefinite
Savings card: innoviCares lists Advagraf (Ontario list dated 2026-09-10) — pays part of the brand-versus-generic difference after other coverage; free sign-up. (innovicares.ca ↗)
1 brand, same coverage
Advagraf · DIN 02296462
Manufacturer: Astellas Pharma Canada Inc.; listing date 2009-04-01
Health Canada: Marketed since 2008-04-09 · brand ADVAGRAF · ATC L04AD02 TACROLIMUS · form Capsule (extended-release) · route Oral · ingredients TACROLIMUS 0.5 MG · company Astellas pharma canada inc · schedule Prescription
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=78179 · Verify on the e-Formulary ↗ (DIN 02296462)
Source record
DIN 02296462: Advagraf
Raw flags: sec12=Y, sec3=Y
Item: 920000591; group id 964; item number 2289; lccId 00200; manufacturer id ASE
Source form: ER Cap; strength: 0.5mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $2.2199; ministry $1.2209
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02296462
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=78179Interchangeable products
Sandoz Tacrolimus XR · DIN 02528592 · $1.2209
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02296462
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Limited Use — Reason for Use code 410 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 410 required
Write on scriptLU code 410 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 410
Reason for Use code 410
For prophylaxis of organ rejection in adult patients receiving allogeneic kidney transplants
Coverage limit:
LU Authorization Period: Indefinite
1 brand, same coverage
Sandoz Tacrolimus XR · DIN 02528592
Manufacturer: Sandoz Canada Inc.; listing date 2026-05-29
Health Canada: Marketed since 2026-04-20 · brand SANDOZ TACROLIMUS XR · ATC L04AD02 TACROLIMUS · form Capsule (extended-release) · route Oral · ingredients TACROLIMUS 0.5 MG · company Sandoz canada incorporated · schedule Prescription
Sandoz Tacrolimus XR: Formulary list price $1.2209/unit (unit not stated in source; not the patient's cost)
Ministry pays: $1.2209 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=101780 · Verify on the e-Formulary ↗ (DIN 02528592)
Source record
DIN 02528592: Sandoz Tacrolimus XR
Raw flags: sec12=Y, sec3=Y
Item: 920000591; group id 964; item number 2289; lccId 00200; manufacturer id SDZ
Source form: ER Cap; strength: 0.5mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $1.2209; ministry $1.2209
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02528592
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=101780Interchangeable products
Advagraf · DIN 02296462 · $1.2209
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02528592
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Envarsus PA · DIN 02485877 · 0.75mg · extended release tablet
Limited Use — Reason for Use code 590 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 590 required
Write on scriptLU code 590 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 590
Reason for Use code 590
For the prophylaxis of organ rejection in allogenic kidney or liver transplant adult patients in combination with other immunosuppressants.
Coverage limit:
LU Authorization Period: Indefinite
No interchangeable product listed in the Ontario extract
Envarsus PA · DIN 02485877
Manufacturer: Endo Ventures Ltd.; listing date 2020-09-30
Health Canada: Marketed since 2026-03-23 · brand ENVARSUS PA · ATC L04AD02 TACROLIMUS · form Tablet (extended-release) · route Oral · ingredients TACROLIMUS 0.75 MG · company Knight therapeutics inc. · schedule Prescription
Envarsus PA: Formulary list price $2.0999/unit (unit not stated in source; not the patient's cost)
Ministry pays: $2.0999 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=97609 · Verify on the e-Formulary ↗ (DIN 02485877)
Source record
DIN 02485877: Envarsus PA
Raw flags: sec12=Y, sec3=Y
Item: 924400008; group id 1046; item number 2398; lccId 00340; manufacturer id EVL
Source form: ER Tab; strength: 0.75mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $2.0999; ministry $2.0999
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02485877
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=97609
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02485877
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Ach-Tacrolimus · DIN 02456095 · 1mg · capsule
Limited Use — Reason for Use code 173 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 173 required
Write on scriptLU code 173 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 173
Reason for Use code 173
For solid organ transplant and bone marrow transplant.
Coverage limit:
LU Authorization Period: Indefinite
Brand vs generic price
Lowest DBP recovery rule under medically necessary no-substitution claims:
6.2 Medically Necessary "No Substitution" Claims
The Side Effect Reporting Form will not have to be renewed. However, the
pharmacy must maintain a copy of the prescription that contains a direction that
there be no substitution and the required Health Canada Side Effect Reporting Form
(completed and signed by the prescriber). The prescriber must write “No
Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and
indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will
be reimbursed the DBP plus a mark-up and the lesser of the posted usual and
customary fee or the ODB dispensing fee minus the applicable ODB co-payment
amount. Where a completed Side Effect Reporting Form is not available at the
pharmacy during an inspection, the difference between the cost of the higher-cost
product and the lowest DBP listed for the interchangeable category will be
recovered.
(ontario.ca, Revision #17; 2026-08-03 ↗)
6.2 Medically Necessary "No Substitution" Claims
The Ministry will provide reimbursement of a higher-cost interchangeable product in
medically necessary circumstances where a patient has experienced a significant
adverse reaction with two (2) lower-cost interchangeable drug products, where
available. When a prescriber identifies a patient for which it is medically necessary
that a higher cost interchangeable product be provided, the prescriber must:
• Complete, sign and forward to the pharmacist a copy of the Health Canada
side effect reporting form for each lower-cost interchangeable drug product
trialed (Side Effect Reporting Form[s]); and
• Write “No Substitution” or “No Sub” on a written prescription or indicate “No
Substitution” to the pharmacist in the case of a verbal prescription.
The prescriber should keep a copy of the completed form in the patient’s record for
future use and reference.
In the case of a written prescription, when the pharmacist or dispensing physician
receives a prescription with the written notation “No Substitution” or “No Sub”,
reimbursement will be provided for the higher-cost interchangeable product only if
the prescription is accompanied by a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed.
This form must be completely filled out noting the details of the adverse reaction
and signed by the prescriber.
In the case of a verbal prescription, the prescriber must satisfy the operator of the
pharmacy or dispensing physician that a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed
has been completed and signed by the prescriber. A written record of this verbal
prescription and the completed Health Canada Side Effect Reporting Form must be
received by the pharmacy prior to claim submission.
Upon receipt, the pharmacist must:
• Fax, submit online or mail the completed and signed form to Health Canada’s
Canada Vigilance Program; and
• Retain his or her copy of the completed and signed Side Effect Reporting
Form.
(ontario.ca, Revision #17; 2026-08-03 ↗)
1 brand, same coverage
Ach-Tacrolimus · DIN 02456095
Manufacturer: Accord Healthcare Inc.; listing date 2023-11-30
Health Canada: Marketed since 2023-09-15 · brand ACH-TACROLIMUS · ATC L04AD02 TACROLIMUS · form Capsule (immediate-release) · route Oral · ingredients TACROLIMUS 1 MG · company Accord healthcare inc · schedule Prescription
Ach-Tacrolimus: Formulary list price $1.2978/unit (unit not stated in source; not the patient's cost)
Ministry pays: $1.2978 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=94294 · Verify on the e-Formulary ↗ (DIN 02456095)
Source record
DIN 02456095: Ach-Tacrolimus
Raw flags: sec12=Y, sec3=Y
Item: 920000221; group id 963; item number 2287; lccId 00137; manufacturer id ACH
Source form: Cap; strength: 1mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $1.2978; ministry $1.2978
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02456095
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=94294Interchangeable products
Prograf · DIN 02175991 · $1.2978
Sandoz Tacrolimus · DIN 02416824 · $1.2978
Shortage status: resolved shortage (ended 2026-07-09); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02456095
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Prograf · DIN 02175991 · 1mg · capsule
Limited Use — Reason for Use code 173 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 173 required
Write on scriptLU code 173 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 173
Reason for Use code 173
For solid organ transplant and bone marrow transplant.
Coverage limit:
LU Authorization Period: Indefinite
Savings card: innoviCares lists Prograf (Ontario list dated 2026-09-10) — pays part of the brand-versus-generic difference after other coverage; free sign-up. (innovicares.ca ↗)
1 brand, same coverage
Prograf · DIN 02175991
Manufacturer: Astellas Pharma Canada Inc.; listing date 1996-12-19
Health Canada: Marketed since 2006-04-03 · brand PROGRAF · ATC L04AD02 TACROLIMUS · form Capsule · route Oral · ingredients TACROLIMUS 1 MG · company Astellas pharma canada inc · schedule Prescription
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=44211 · Verify on the e-Formulary ↗ (DIN 02175991)
Source record
DIN 02175991: Prograf
Raw flags: sec12=Y, sec3=Y
Item: 920000221; group id 963; item number 2287; lccId 00137; manufacturer id ASE
Source form: Cap; strength: 1mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $2.5956; ministry $1.2978
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02175991
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=44211Interchangeable products
Ach-Tacrolimus · DIN 02456095 · $1.2978
Sandoz Tacrolimus · DIN 02416824 · $1.2978
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02175991
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Sandoz Tacrolimus · DIN 02416824 · 1mg · capsule
Limited Use — Reason for Use code 173 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 173 required
Write on scriptLU code 173 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 173
Reason for Use code 173
For solid organ transplant and bone marrow transplant.
Coverage limit:
LU Authorization Period: Indefinite
Brand vs generic price
Lowest DBP recovery rule under medically necessary no-substitution claims:
6.2 Medically Necessary "No Substitution" Claims
The Side Effect Reporting Form will not have to be renewed. However, the
pharmacy must maintain a copy of the prescription that contains a direction that
there be no substitution and the required Health Canada Side Effect Reporting Form
(completed and signed by the prescriber). The prescriber must write “No
Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and
indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will
be reimbursed the DBP plus a mark-up and the lesser of the posted usual and
customary fee or the ODB dispensing fee minus the applicable ODB co-payment
amount. Where a completed Side Effect Reporting Form is not available at the
pharmacy during an inspection, the difference between the cost of the higher-cost
product and the lowest DBP listed for the interchangeable category will be
recovered.
(ontario.ca, Revision #17; 2026-08-03 ↗)
6.2 Medically Necessary "No Substitution" Claims
The Ministry will provide reimbursement of a higher-cost interchangeable product in
medically necessary circumstances where a patient has experienced a significant
adverse reaction with two (2) lower-cost interchangeable drug products, where
available. When a prescriber identifies a patient for which it is medically necessary
that a higher cost interchangeable product be provided, the prescriber must:
• Complete, sign and forward to the pharmacist a copy of the Health Canada
side effect reporting form for each lower-cost interchangeable drug product
trialed (Side Effect Reporting Form[s]); and
• Write “No Substitution” or “No Sub” on a written prescription or indicate “No
Substitution” to the pharmacist in the case of a verbal prescription.
The prescriber should keep a copy of the completed form in the patient’s record for
future use and reference.
In the case of a written prescription, when the pharmacist or dispensing physician
receives a prescription with the written notation “No Substitution” or “No Sub”,
reimbursement will be provided for the higher-cost interchangeable product only if
the prescription is accompanied by a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed.
This form must be completely filled out noting the details of the adverse reaction
and signed by the prescriber.
In the case of a verbal prescription, the prescriber must satisfy the operator of the
pharmacy or dispensing physician that a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed
has been completed and signed by the prescriber. A written record of this verbal
prescription and the completed Health Canada Side Effect Reporting Form must be
received by the pharmacy prior to claim submission.
Upon receipt, the pharmacist must:
• Fax, submit online or mail the completed and signed form to Health Canada’s
Canada Vigilance Program; and
• Retain his or her copy of the completed and signed Side Effect Reporting
Form.
(ontario.ca, Revision #17; 2026-08-03 ↗)
1 brand, same coverage
Sandoz Tacrolimus · DIN 02416824
Manufacturer: Sandoz Canada Inc.; listing date 2014-01-30
Health Canada: Marketed since 2013-11-25 · brand SANDOZ TACROLIMUS · ATC L04AD02 TACROLIMUS · form Capsule (immediate-release) · route Oral · ingredients TACROLIMUS (TACROLIMUS MONOHYDRATE) 1 MG · company Sandoz canada incorporated · schedule Prescription
Sandoz Tacrolimus: Formulary list price $1.2978/unit (unit not stated in source; not the patient's cost)
Ministry pays: $1.2978 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=90143 · Verify on the e-Formulary ↗ (DIN 02416824)
Source record
DIN 02416824: Sandoz Tacrolimus
Raw flags: sec12=Y, sec3=Y
Item: 920000221; group id 963; item number 2287; lccId 00137; manufacturer id SDZ
Source form: Cap; strength: 1mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $1.2978; ministry $1.2978
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02416824
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=90143Interchangeable products
Ach-Tacrolimus · DIN 02456095 · $1.2978
Prograf · DIN 02175991 · $1.2978
Shortage status: resolved shortage (ended 2025-11-28); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02416824
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Advagraf · DIN 02296470 · 1mg · extended release capsule
Limited Use — Reason for Use code 410 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 410 required
Write on scriptLU code 410 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 410
Reason for Use code 410
For prophylaxis of organ rejection in adult patients receiving allogeneic kidney transplants
Coverage limit:
LU Authorization Period: Indefinite
Savings card: innoviCares lists Advagraf (Ontario list dated 2026-09-10) — pays part of the brand-versus-generic difference after other coverage; free sign-up. (innovicares.ca ↗)
1 brand, same coverage
Advagraf · DIN 02296470
Manufacturer: Astellas Pharma Canada Inc.; listing date 2009-04-01
Health Canada: Marketed since 2008-04-09 · brand ADVAGRAF · ATC L04AD02 TACROLIMUS · form Capsule (extended-release) · route Oral · ingredients TACROLIMUS 1 MG · company Astellas pharma canada inc · schedule Prescription
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=78180 · Verify on the e-Formulary ↗ (DIN 02296470)
Source record
DIN 02296470: Advagraf
Raw flags: sec12=Y, sec3=Y
Item: 920000592; group id 964; item number 2290; lccId 00200; manufacturer id ASE
Source form: ER Cap; strength: 1mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $2.8396; ministry $1.5618
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02296470
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=78180Interchangeable products
Sandoz Tacrolimus XR · DIN 02528606 · $1.5618
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02296470
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Limited Use — Reason for Use code 410 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 410 required
Write on scriptLU code 410 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 410
Reason for Use code 410
For prophylaxis of organ rejection in adult patients receiving allogeneic kidney transplants
Coverage limit:
LU Authorization Period: Indefinite
1 brand, same coverage
Sandoz Tacrolimus XR · DIN 02528606
Manufacturer: Sandoz Canada Inc.; listing date 2025-12-30
Health Canada: Marketed since 2025-11-25 · brand SANDOZ TACROLIMUS XR · ATC L04AD02 TACROLIMUS · form Capsule (extended-release) · route Oral · ingredients TACROLIMUS 1 MG · company Sandoz canada incorporated · schedule Prescription
Sandoz Tacrolimus XR: Formulary list price $1.5618/unit (unit not stated in source; not the patient's cost)
Ministry pays: $1.5618 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=101781 · Verify on the e-Formulary ↗ (DIN 02528606)
Source record
DIN 02528606: Sandoz Tacrolimus XR
Raw flags: sec12=Y, sec3=Y
Item: 920000592; group id 964; item number 2290; lccId 00200; manufacturer id SDZ
Source form: ER Cap; strength: 1mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $1.5618; ministry $1.5618
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02528606
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=101781Interchangeable products
Advagraf · DIN 02296470 · $1.5618
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02528606
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Envarsus PA · DIN 02485885 · 1mg · extended release tablet
Limited Use — Reason for Use code 590 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 590 required
Write on scriptLU code 590 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 590
Reason for Use code 590
For the prophylaxis of organ rejection in allogenic kidney or liver transplant adult patients in combination with other immunosuppressants.
Coverage limit:
LU Authorization Period: Indefinite
No interchangeable product listed in the Ontario extract
Envarsus PA · DIN 02485885
Manufacturer: Endo Ventures Ltd.; listing date 2020-09-30
Health Canada: Marketed since 2026-03-23 · brand ENVARSUS PA · ATC L04AD02 TACROLIMUS · form Tablet (extended-release) · route Oral · ingredients TACROLIMUS 1 MG · company Knight therapeutics inc. · schedule Prescription
Envarsus PA: Formulary list price $2.7430/unit (unit not stated in source; not the patient's cost)
Ministry pays: $2.7430 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=97610 · Verify on the e-Formulary ↗ (DIN 02485885)
Source record
DIN 02485885: Envarsus PA
Raw flags: sec12=Y, sec3=Y
Item: 924400009; group id 1046; item number 2399; lccId 00340; manufacturer id EVL
Source form: ER Tab; strength: 1mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $2.7430; ministry $2.7430
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02485885
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=97610
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02485885
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Advagraf · DIN 02331667 · 3mg · extended release capsule
Limited Use — Reason for Use code 410 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 410 required
Write on scriptLU code 410 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 410
Reason for Use code 410
For prophylaxis of organ rejection in adult patients receiving allogeneic kidney transplants
Coverage limit:
LU Authorization Period: Indefinite
Savings card: innoviCares lists Advagraf (Ontario list dated 2026-09-10) — pays part of the brand-versus-generic difference after other coverage; free sign-up. (innovicares.ca ↗)
1 brand, same coverage
Advagraf · DIN 02331667
Manufacturer: Astellas Pharma Canada Inc.; listing date 2011-03-15
Health Canada: Marketed since 2010-04-05 · brand ADVAGRAF · ATC L04AD02 TACROLIMUS · form Capsule (extended-release) · route Oral · ingredients TACROLIMUS 3 MG · company Astellas pharma canada inc · schedule Prescription
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=81736 · Verify on the e-Formulary ↗ (DIN 02331667)
Source record
DIN 02331667: Advagraf
Raw flags: sec12=Y, sec3=Y
Item: 920000621; group id 964; item number 2291; lccId 00200; manufacturer id ASE
Source form: ER Cap; strength: 3mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $8.5188; ministry $4.6853
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02331667
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=81736Interchangeable products
Sandoz Tacrolimus XR · DIN 02528622 · $4.6853
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02331667
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Limited Use — Reason for Use code 410 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 410 required
Write on scriptLU code 410 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 410
Reason for Use code 410
For prophylaxis of organ rejection in adult patients receiving allogeneic kidney transplants
Coverage limit:
LU Authorization Period: Indefinite
1 brand, same coverage
Sandoz Tacrolimus XR · DIN 02528622
Manufacturer: Sandoz Canada Inc.; listing date 2025-12-30
Health Canada: Marketed since 2025-11-25 · brand SANDOZ TACROLIMUS XR · ATC L04AD02 TACROLIMUS · form Capsule (extended-release) · route Oral · ingredients TACROLIMUS 3 MG · company Sandoz canada incorporated · schedule Prescription
Sandoz Tacrolimus XR: Formulary list price $4.6853/unit (unit not stated in source; not the patient's cost)
Ministry pays: $4.6853 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=101783 · Verify on the e-Formulary ↗ (DIN 02528622)
Source record
DIN 02528622: Sandoz Tacrolimus XR
Raw flags: sec12=Y, sec3=Y
Item: 920000621; group id 964; item number 2291; lccId 00200; manufacturer id SDZ
Source form: ER Cap; strength: 3mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $4.6853; ministry $4.6853
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02528622
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=101783Interchangeable products
Advagraf · DIN 02331667 · $4.6853
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02528622
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Envarsus PA · DIN 02485893 · 4mg · extended release tablet
Limited Use — Reason for Use code 590 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 590 required
Write on scriptLU code 590 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 590
Reason for Use code 590
For the prophylaxis of organ rejection in allogenic kidney or liver transplant adult patients in combination with other immunosuppressants.
Coverage limit:
LU Authorization Period: Indefinite
No interchangeable product listed in the Ontario extract
Envarsus PA · DIN 02485893
Manufacturer: Endo Ventures Ltd.; listing date 2020-09-30
Health Canada: Marketed since 2026-03-23 · brand ENVARSUS PA · ATC L04AD02 TACROLIMUS · form Tablet (extended-release) · route Oral · ingredients TACROLIMUS 4 MG · company Knight therapeutics inc. · schedule Prescription
Envarsus PA: Formulary list price $10.9719/unit (unit not stated in source; not the patient's cost)
Ministry pays: $10.9719 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=97611 · Verify on the e-Formulary ↗ (DIN 02485893)
Source record
DIN 02485893: Envarsus PA
Raw flags: sec12=Y, sec3=Y
Item: 924400010; group id 1046; item number 2400; lccId 00340; manufacturer id EVL
Source form: ER Tab; strength: 4mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $10.9719; ministry $10.9719
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02485893
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=97611
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02485893
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Prograf · DIN 02176009 · 5mg/mL · Amp
Limited Use — Reason for Use code 173 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 173 required
Write on scriptLU code 173 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 173
Reason for Use code 173
For solid organ transplant and bone marrow transplant.
Coverage limit:
LU Authorization Period: Indefinite
Savings card: innoviCares lists Prograf (Ontario list dated 2026-09-10) — pays part of the brand-versus-generic difference after other coverage; free sign-up. (innovicares.ca ↗)
No interchangeable product listed in the Ontario extract
Prograf · DIN 02176009
Manufacturer: Astellas Pharma Canada Inc.; listing date 1996-12-19
Health Canada: Marketed since 2005-09-15 · brand PROGRAF · ATC L04AD02 TACROLIMUS · form Solution · route Intravenous · ingredients TACROLIMUS 5 MG/ML · company Astellas pharma canada inc · schedule Prescription
Prograf: Formulary list price $128.2350/unit (unit not stated in source; not the patient's cost)
Ministry pays: $128.2350 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=44212 · Verify on the e-Formulary ↗ (DIN 02176009)
Source record
DIN 02176009: Prograf
Raw flags: sec12=Y, sec3=Y
Item: 920000224; group id 963; item number 2285; lccId 00137; manufacturer id ASE
Source form: Amp; strength: 5mg/mL
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $128.2350; ministry $128.2350
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02176009
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=44212
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02176009
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Ach-Tacrolimus · DIN 02456109 · 5mg · capsule
Limited Use — Reason for Use code 173 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 173 required
Write on scriptLU code 173 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 173
Reason for Use code 173
For solid organ transplant and bone marrow transplant.
Coverage limit:
LU Authorization Period: Indefinite
Brand vs generic price
Lowest DBP recovery rule under medically necessary no-substitution claims:
6.2 Medically Necessary "No Substitution" Claims
The Side Effect Reporting Form will not have to be renewed. However, the
pharmacy must maintain a copy of the prescription that contains a direction that
there be no substitution and the required Health Canada Side Effect Reporting Form
(completed and signed by the prescriber). The prescriber must write “No
Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and
indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will
be reimbursed the DBP plus a mark-up and the lesser of the posted usual and
customary fee or the ODB dispensing fee minus the applicable ODB co-payment
amount. Where a completed Side Effect Reporting Form is not available at the
pharmacy during an inspection, the difference between the cost of the higher-cost
product and the lowest DBP listed for the interchangeable category will be
recovered.
(ontario.ca, Revision #17; 2026-08-03 ↗)
6.2 Medically Necessary "No Substitution" Claims
The Ministry will provide reimbursement of a higher-cost interchangeable product in
medically necessary circumstances where a patient has experienced a significant
adverse reaction with two (2) lower-cost interchangeable drug products, where
available. When a prescriber identifies a patient for which it is medically necessary
that a higher cost interchangeable product be provided, the prescriber must:
• Complete, sign and forward to the pharmacist a copy of the Health Canada
side effect reporting form for each lower-cost interchangeable drug product
trialed (Side Effect Reporting Form[s]); and
• Write “No Substitution” or “No Sub” on a written prescription or indicate “No
Substitution” to the pharmacist in the case of a verbal prescription.
The prescriber should keep a copy of the completed form in the patient’s record for
future use and reference.
In the case of a written prescription, when the pharmacist or dispensing physician
receives a prescription with the written notation “No Substitution” or “No Sub”,
reimbursement will be provided for the higher-cost interchangeable product only if
the prescription is accompanied by a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed.
This form must be completely filled out noting the details of the adverse reaction
and signed by the prescriber.
In the case of a verbal prescription, the prescriber must satisfy the operator of the
pharmacy or dispensing physician that a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed
has been completed and signed by the prescriber. A written record of this verbal
prescription and the completed Health Canada Side Effect Reporting Form must be
received by the pharmacy prior to claim submission.
Upon receipt, the pharmacist must:
• Fax, submit online or mail the completed and signed form to Health Canada’s
Canada Vigilance Program; and
• Retain his or her copy of the completed and signed Side Effect Reporting
Form.
(ontario.ca, Revision #17; 2026-08-03 ↗)
1 brand, same coverage
Ach-Tacrolimus · DIN 02456109
Manufacturer: Accord Healthcare Inc.; listing date 2023-11-30
Health Canada: Marketed since 2023-09-15 · brand ACH-TACROLIMUS · ATC L04AD02 TACROLIMUS · form Capsule (immediate-release) · route Oral · ingredients TACROLIMUS 5 MG · company Accord healthcare inc · schedule Prescription
Ach-Tacrolimus: Formulary list price $6.4993/unit (unit not stated in source; not the patient's cost)
Ministry pays: $6.4993 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=94295 · Verify on the e-Formulary ↗ (DIN 02456109)
Source record
DIN 02456109: Ach-Tacrolimus
Raw flags: sec12=Y, sec3=Y
Item: 920000222; group id 963; item number 2288; lccId 00137; manufacturer id ACH
Source form: Cap; strength: 5mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $6.4993; ministry $6.4993
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02456109
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=94295Interchangeable products
Prograf · DIN 02175983 · $6.4993
Sandoz Tacrolimus · DIN 02416832 · $6.4993
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02456109
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Prograf · DIN 02175983 · 5mg · capsule
Limited Use — Reason for Use code 173 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 173 required
Write on scriptLU code 173 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 173
Reason for Use code 173
For solid organ transplant and bone marrow transplant.
Coverage limit:
LU Authorization Period: Indefinite
Savings card: innoviCares lists Prograf (Ontario list dated 2026-09-10) — pays part of the brand-versus-generic difference after other coverage; free sign-up. (innovicares.ca ↗)
1 brand, same coverage
Prograf · DIN 02175983
Manufacturer: Astellas Pharma Canada Inc.; listing date 1996-12-19
Health Canada: Marketed since 2006-04-03 · brand PROGRAF · ATC L04AD02 TACROLIMUS · form Capsule · route Oral · ingredients TACROLIMUS 5 MG · company Astellas pharma canada inc · schedule Prescription
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=44210 · Verify on the e-Formulary ↗ (DIN 02175983)
Source record
DIN 02175983: Prograf
Raw flags: sec12=Y, sec3=Y
Item: 920000222; group id 963; item number 2288; lccId 00137; manufacturer id ASE
Source form: Cap; strength: 5mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $12.9986; ministry $6.4993
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02175983
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=44210Interchangeable products
Ach-Tacrolimus · DIN 02456109 · $6.4993
Sandoz Tacrolimus · DIN 02416832 · $6.4993
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02175983
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Sandoz Tacrolimus · DIN 02416832 · 5mg · capsule
Limited Use — Reason for Use code 173 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 173 required
Write on scriptLU code 173 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 173
Reason for Use code 173
For solid organ transplant and bone marrow transplant.
Coverage limit:
LU Authorization Period: Indefinite
Brand vs generic price
Lowest DBP recovery rule under medically necessary no-substitution claims:
6.2 Medically Necessary "No Substitution" Claims
The Side Effect Reporting Form will not have to be renewed. However, the
pharmacy must maintain a copy of the prescription that contains a direction that
there be no substitution and the required Health Canada Side Effect Reporting Form
(completed and signed by the prescriber). The prescriber must write “No
Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and
indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will
be reimbursed the DBP plus a mark-up and the lesser of the posted usual and
customary fee or the ODB dispensing fee minus the applicable ODB co-payment
amount. Where a completed Side Effect Reporting Form is not available at the
pharmacy during an inspection, the difference between the cost of the higher-cost
product and the lowest DBP listed for the interchangeable category will be
recovered.
(ontario.ca, Revision #17; 2026-08-03 ↗)
6.2 Medically Necessary "No Substitution" Claims
The Ministry will provide reimbursement of a higher-cost interchangeable product in
medically necessary circumstances where a patient has experienced a significant
adverse reaction with two (2) lower-cost interchangeable drug products, where
available. When a prescriber identifies a patient for which it is medically necessary
that a higher cost interchangeable product be provided, the prescriber must:
• Complete, sign and forward to the pharmacist a copy of the Health Canada
side effect reporting form for each lower-cost interchangeable drug product
trialed (Side Effect Reporting Form[s]); and
• Write “No Substitution” or “No Sub” on a written prescription or indicate “No
Substitution” to the pharmacist in the case of a verbal prescription.
The prescriber should keep a copy of the completed form in the patient’s record for
future use and reference.
In the case of a written prescription, when the pharmacist or dispensing physician
receives a prescription with the written notation “No Substitution” or “No Sub”,
reimbursement will be provided for the higher-cost interchangeable product only if
the prescription is accompanied by a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed.
This form must be completely filled out noting the details of the adverse reaction
and signed by the prescriber.
In the case of a verbal prescription, the prescriber must satisfy the operator of the
pharmacy or dispensing physician that a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed
has been completed and signed by the prescriber. A written record of this verbal
prescription and the completed Health Canada Side Effect Reporting Form must be
received by the pharmacy prior to claim submission.
Upon receipt, the pharmacist must:
• Fax, submit online or mail the completed and signed form to Health Canada’s
Canada Vigilance Program; and
• Retain his or her copy of the completed and signed Side Effect Reporting
Form.
(ontario.ca, Revision #17; 2026-08-03 ↗)
1 brand, same coverage
Sandoz Tacrolimus · DIN 02416832
Manufacturer: Sandoz Canada Inc.; listing date 2014-01-30
Health Canada: Marketed since 2013-11-25 · brand SANDOZ TACROLIMUS · ATC L04AD02 TACROLIMUS · form Capsule (immediate-release) · route Oral · ingredients TACROLIMUS (TACROLIMUS MONOHYDRATE) 5 MG · company Sandoz canada incorporated · schedule Prescription
Sandoz Tacrolimus: Formulary list price $6.4993/unit (unit not stated in source; not the patient's cost)
Ministry pays: $6.4993 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=90144 · Verify on the e-Formulary ↗ (DIN 02416832)
Source record
DIN 02416832: Sandoz Tacrolimus
Raw flags: sec12=Y, sec3=Y
Item: 920000222; group id 963; item number 2288; lccId 00137; manufacturer id SDZ
Source form: Cap; strength: 5mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $6.4993; ministry $6.4993
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02416832
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=90144Interchangeable products
Ach-Tacrolimus · DIN 02456109 · $6.4993
Prograf · DIN 02175983 · $6.4993
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02416832
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Advagraf · DIN 02296489 · 5mg · extended release capsule
Limited Use — Reason for Use code 410 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 410 required
Write on scriptLU code 410 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 410
Reason for Use code 410
For prophylaxis of organ rejection in adult patients receiving allogeneic kidney transplants
Coverage limit:
LU Authorization Period: Indefinite
Savings card: innoviCares lists Advagraf (Ontario list dated 2026-09-10) — pays part of the brand-versus-generic difference after other coverage; free sign-up. (innovicares.ca ↗)
1 brand, same coverage
Advagraf · DIN 02296489
Manufacturer: Astellas Pharma Canada Inc.; listing date 2009-04-01
Health Canada: Marketed since 2008-04-09 · brand ADVAGRAF · ATC L04AD02 TACROLIMUS · form Capsule (extended-release) · route Oral · ingredients TACROLIMUS 5 MG · company Astellas pharma canada inc · schedule Prescription
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=78181 · Verify on the e-Formulary ↗ (DIN 02296489)
Source record
DIN 02296489: Advagraf
Raw flags: sec12=Y, sec3=Y
Item: 920000593; group id 964; item number 2292; lccId 00200; manufacturer id ASE
Source form: ER Cap; strength: 5mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $14.2205; ministry $7.8213
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02296489
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=78181Interchangeable products
Sandoz Tacrolimus XR · DIN 02528630 · $7.8213
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02296489
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Limited Use — Reason for Use code 410 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 410 required
Write on scriptLU code 410 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 410
Reason for Use code 410
For prophylaxis of organ rejection in adult patients receiving allogeneic kidney transplants
Coverage limit:
LU Authorization Period: Indefinite
1 brand, same coverage
Sandoz Tacrolimus XR · DIN 02528630
Manufacturer: Sandoz Canada Inc.; listing date 2025-12-30
Health Canada: Marketed since 2025-11-25 · brand SANDOZ TACROLIMUS XR · ATC L04AD02 TACROLIMUS · form Capsule (extended-release) · route Oral · ingredients TACROLIMUS 5 MG · company Sandoz canada incorporated · schedule Prescription
Sandoz Tacrolimus XR: Formulary list price $7.8213/unit (unit not stated in source; not the patient's cost)
Ministry pays: $7.8213 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=101784 · Verify on the e-Formulary ↗ (DIN 02528630)
Source record
DIN 02528630: Sandoz Tacrolimus XR
Raw flags: sec12=Y, sec3=Y
Item: 920000593; group id 964; item number 2292; lccId 00200; manufacturer id SDZ
Source form: ER Cap; strength: 5mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $7.8213; ministry $7.8213
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02528630
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=101784Interchangeable products
Advagraf · DIN 02296489 · $7.8213
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02528630
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Other drugs in the same formulary classes and how they are covered
Other drugs in the same formulary class (92:00 UNCLASSIFIED THERAPEUTIC AGENTS) and how they are covered
· 3 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 267mg · Cap
Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 92:00
and 74 more
Other drugs in the same formulary class (92:44 Immunosuppressive Agents) and how they are covered
Matched class: 92:44 Immunosuppressive Agents
Drug-class inventory only. Lists recorded Ontario formulary products, not every Canadian medication; does not recommend treatment.
No displayed product is listed as a general benefit in this extract. Check its listing requirements below.
92:44 Immunosuppressive Agents
From Health Canada product monographs; label wording only, not a treatment recommendation.
Matching is lexical and uses one held product label per generic; formulations and qualifying criteria may differ.
Covered without a code on the Ontario formulary: LEFLUNOMIDE, PENICILLAMINE, SULFASALAZINE
CYCLOSPORINE · Off-Formulary Interchangeable, not an ODB benefit (2), General benefit (8)
Rheumatoid Arthritis
NEORAL capsules and oral solution (cyclosporine) are also indicated for the treatment of severe active
rheumatoid arthritis in patients for whom classical slow-acting antirheumatic agents are inappropriate or
ineffective.
PM: https://pdf.hres.ca/dpd_pm/00085584.PDF; date 2026-07-30; DIN 02150662; fetched 2026-09-10
Product monographLEFLUNOMIDE · General benefit
ARAVA is indicated in adults for the treatment of active rheumatoid arthritis.
1.1 Pediatrics
The use in patients less than 18 years of age is contraindicated.
1.2 Geriatrics
No dosage adjustment is needed in patients over 65 years of age.
PM: https://pdf.hres.ca/dpd_pm/00083555.PDF; date not captured; DIN 02241888; fetched 2026-09-10
Product monographPENICILLAMINE · General benefit
INDICATIONS AND CLINICAL USE
CUPRIMINE (penicillamine capsules, USP) is indicated for:
treatment of Wilson's disease
chronic lead poisoning
cystinuria, and
In patients with severe, active rheumatoid arthritis who have failed to respond to an
adequate trial of conventional therapy.
PM: https://pdf.hres.ca/dpd_pm/00054287.PDF; date not captured; DIN 00016055; fetched 2026-09-10
Product monographSULFASALAZINE · General benefit
It is especially useful for
chronic administration.
pms-SULFASALAZINE-E.C. is also indicated for the treatment of active rheumatoid arthritis,
when treatment with an adequate conventional first line therapy has failed.
PM: https://pdf.hres.ca/dpd_pm/00056638.PDF; date April 30, 2020; DIN 00598461; fetched 2026-09-10
Product monograph
Coverage source: ON formulary extract 2026-08-26
What the Health Canada label says it is for
1 INDICATIONS
Transplantation
Prograf® (tacrolimus) is indicated for:
• prophylaxis of organ rejection in patients receiving allogeneic liver, kidney or heart transplants.
• treatment of refractory rejection in patients receiving allogeneic liver or kidney transplants.
Prograf is to be used concomitantly with adrenal corticosteroids and other immunosuppressive agents.
The safety and efficacy of the use of Prograf with sirolimus has not been established.
Only physicians experienced in immunosuppressive therapy and management of organ transplant
should prescribe Prograf (tacrolimus). Patients receiving the drug should be managed in facilities
equipped and staffed with adequate laboratory and supportive medical resources. The physician
responsible for maintenance therapy should have complete information requisite for the follow-up of
the patient.
Rheumatoid Arthritis
Prograf (tacrolimus immediate-release capsules, USP) is indicated for:
• treatment of active rheumatoid arthritis in adult patients for whom disease modifying
anti-rheumatic drug (DMARD) therapy is ineffective or inappropriate.
Prograf may be used as monotherapy or in combination with non-st…
https://pdf.hres.ca/dpd_pm/00082912.PDF
PM date: 2025-12-17
Source product: PROGRAF; DIN 02175983; fetched 2026-09-10
Product monograph posted by Health Canada; excerpt for lookup only.
Availability
Protopic · DIN 02244149
Shortage status: discontinued (2025-04-15, reported by LEO PHARMA INC); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02244149
Protopic · DIN 02244148
Shortage status: discontinued (2025-04-15, reported by LEO PHARMA INC); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02244148