All strengths: Limited Use — Reason for Use code 397 required; same patient cost rules
Shared coverage and patient cost rules
StatusLimited Use — Reason for Use code 397 required
Patient paysPatient pays: program not supplied; amount cannot be determined.
Androgel · DIN 02245345 · 1% · 2.5g Foil Packet
Limited Use — Reason for Use code 397 requiredMarketed · checked 2026-09-02
Write on scriptLU code 397 (patient must meet the criteria below)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 397
Reason for Use code 397
For male patients with confirmed low morning serum testosterone levels associated with documented, symptomatic hypothalamic, pituitary or testicular disease, or in HIV-infected patients.
Note: Older males with nonspecific symptoms of fatigue, malaise, depression who have a low normal random testosterone level do not satisfy these criteria.
Coverage limit:
LU Authorization Period: 1 year
Savings card: RxHelp ONE lists Androgel (read 2026-09-10) — brand-name savings card, free; cannot be combined with another card on the same claim. (rxhelp.ca ↗)
1 brand, same coverage
Androgel · DIN 02245345
Manufacturer: Solvay Pharma Inc.; listing date 2005-02-22
Health Canada: Marketed since 2016-04-07 · brand ANDROGEL · ATC G03BA03 TESTOSTERONE · form Gel · route Transdermal · ingredients TESTOSTERONE 1 % · company Bgp pharma ulc · schedule Controlled drugs (cdsa iv)
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=69384 · Verify on the e-Formulary ↗ (DIN 02245345)
Source record
DIN 02245345: Androgel
Raw flags: sec12=Y, sec3=Y
Item: 680800030; group id 723; item number 1784; lccId 00160; manufacturer id SPH
Source form: 2.5g Foil Packet; strength: 1%
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $2.5514; ministry $1.6726
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02245345
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=69384Interchangeable products
Taro-Testosterone Gel · DIN 02463792 · $1.6726
Shortage status: resolved shortage (ended 2026-05-05); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02245345
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Taro-Testosterone Gel · DIN 02463792 · 1% · 2.5g Foil Packet
Limited Use — Reason for Use code 397 requiredMarketed · checked 2026-09-02
Write on scriptLU code 397 (patient must meet the criteria below)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 397
Reason for Use code 397
For male patients with confirmed low morning serum testosterone levels associated with documented, symptomatic hypothalamic, pituitary or testicular disease, or in HIV-infected patients.
Note: Older males with nonspecific symptoms of fatigue, malaise, depression who have a low normal random testosterone level do not satisfy these criteria.
Coverage limit:
LU Authorization Period: 1 year
1 brand, same coverage
Taro-Testosterone Gel · DIN 02463792
Manufacturer: Taro Pharmaceuticals Inc.; listing date 2017-12-21
Health Canada: Marketed since 2017-10-31 · brand TARO-TESTOSTERONE GEL · ATC G03BA03 TESTOSTERONE · form Gel · route Transdermal · ingredients TESTOSTERONE 1 % · company Taro pharmaceuticals inc · schedule Controlled drugs (cdsa iv)
Taro-Testosterone Gel: Formulary list price $1.6726/unit (unit not stated in source; not the patient's cost)
Ministry pays: $1.6726 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=95189 · Verify on the e-Formulary ↗ (DIN 02463792)
Source record
DIN 02463792: Taro-Testosterone Gel
Raw flags: sec12=Y, sec3=Y
Item: 680800030; group id 723; item number 1784; lccId 00160; manufacturer id TAR
Source form: 2.5g Foil Packet; strength: 1%
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $1.6726; ministry $1.6726
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02463792
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=95189Interchangeable products
Androgel · DIN 02245345 · $1.6726
Shortage status: active shortage (reported 2026-08-27, estimated to end 2026-10-03, last updated 2026-09-04); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02463792
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Androgel · DIN 02245346 · 1% · 5.0g Foil Packet
Limited Use — Reason for Use code 397 requiredMarketed · checked 2026-09-02
Write on scriptLU code 397 (patient must meet the criteria below)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 397
Reason for Use code 397
For male patients with confirmed low morning serum testosterone levels associated with documented, symptomatic hypothalamic, pituitary or testicular disease, or in HIV-infected patients.
Note: Older males with nonspecific symptoms of fatigue, malaise, depression who have a low normal random testosterone level do not satisfy these criteria.
Coverage limit:
LU Authorization Period: 1 year
Savings card: RxHelp ONE lists Androgel (read 2026-09-10) — brand-name savings card, free; cannot be combined with another card on the same claim. (rxhelp.ca ↗)
1 brand, same coverage
Androgel · DIN 02245346
Manufacturer: Solvay Pharma Inc.; listing date 2005-02-22
Health Canada: Marketed since 2016-04-07 · brand ANDROGEL · ATC G03BA03 TESTOSTERONE · form Gel · route Transdermal · ingredients TESTOSTERONE 1 % · company Bgp pharma ulc · schedule Controlled drugs (cdsa iv)
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=69385 · Verify on the e-Formulary ↗ (DIN 02245346)
Source record
DIN 02245346: Androgel
Raw flags: sec12=Y, sec3=Y
Item: 680800031; group id 723; item number 1785; lccId 00160; manufacturer id SPH
Source form: 5.0g Foil Packet; strength: 1%
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $4.5117; ministry $2.9575
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02245346
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=69385Interchangeable products
Taro-Testosterone Gel · DIN 02463806 · $2.9575
Shortage status: resolved shortage (ended 2026-08-19); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02245346
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Taro-Testosterone Gel · DIN 02463806 · 1% · 5.0g Foil Packet
Limited Use — Reason for Use code 397 requiredMarketed · checked 2026-09-02
Write on scriptLU code 397 (patient must meet the criteria below)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 397
Reason for Use code 397
For male patients with confirmed low morning serum testosterone levels associated with documented, symptomatic hypothalamic, pituitary or testicular disease, or in HIV-infected patients.
Note: Older males with nonspecific symptoms of fatigue, malaise, depression who have a low normal random testosterone level do not satisfy these criteria.
Coverage limit:
LU Authorization Period: 1 year
1 brand, same coverage
Taro-Testosterone Gel · DIN 02463806
Manufacturer: Taro Pharmaceuticals Inc.; listing date 2017-12-21
Health Canada: Marketed since 2017-10-31 · brand TARO-TESTOSTERONE GEL · ATC G03BA03 TESTOSTERONE · form Gel · route Transdermal · ingredients TESTOSTERONE 1 % · company Taro pharmaceuticals inc · schedule Controlled drugs (cdsa iv)
Taro-Testosterone Gel: Formulary list price $2.9575/unit (unit not stated in source; not the patient's cost)
Ministry pays: $2.9575 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=95190 · Verify on the e-Formulary ↗ (DIN 02463806)
Source record
DIN 02463806: Taro-Testosterone Gel
Raw flags: sec12=Y, sec3=Y
Item: 680800031; group id 723; item number 1785; lccId 00160; manufacturer id TAR
Source form: 5.0g Foil Packet; strength: 1%
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $2.9575; ministry $2.9575
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02463806
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=95190Interchangeable products
Androgel · DIN 02245346 · $2.9575
Shortage status: resolved shortage (ended 2020-08-15); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02463806
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Testim · DIN 02280248 · 1% · Top Gel-5g Pk
Limited Use — Reason for Use code 397 requiredMarketed · checked 2026-09-02
Write on scriptLU code 397 (patient must meet the criteria below)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 397
Reason for Use code 397
For male patients with confirmed low morning serum testosterone levels associated with documented, symptomatic hypothalamic, pituitary or testicular disease, or in HIV-infected patients.
Note: Older males with nonspecific symptoms of fatigue, malaise, depression who have a low normal random testosterone level do not satisfy these criteria.
Coverage limit:
LU Authorization Period: 1 year
No interchangeable product listed in the Ontario extract
Testim · DIN 02280248
Manufacturer: Knight Therapeutics Inc.; listing date 2009-09-30
Health Canada: Marketed since 2026-01-16 · brand TESTIM 1% · ATC G03BA03 TESTOSTERONE · form Gel · route Transdermal · ingredients TESTOSTERONE 1 % · company Knight therapeutics inc. · schedule Controlled drugs (cdsa iv)
Testim: Formulary list price $4.4045/unit (unit not stated in source; not the patient's cost)
Ministry pays: $4.4045 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=76591 · Verify on the e-Formulary ↗ (DIN 02280248)
Source record
DIN 02280248: Testim
Raw flags: sec12=Y, sec3=Y
Item: 680800033; group id 723; item number 1786; lccId 00160; manufacturer id KNT
Source form: Top Gel-5g Pk; strength: 1%
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $4.4045; ministry $4.4045
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02280248
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=76591
Shortage status: resolved shortage (ended 2019-07-22); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02280248
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Limited Use — Reason for Use code 397 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 397 required
Write on scriptLU code 397 (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 397
Reason for Use code 397
For male patients with confirmed low morning serum testosterone levels associated with documented, symptomatic hypothalamic, pituitary or testicular disease, or in HIV-infected patients.
Note: Older males with nonspecific symptoms of fatigue, malaise, depression who have a low normal random testosterone level do not satisfy these criteria.
Coverage limit:
LU Authorization Period: 1 year
1 brand, same coverage
Taro-Testosterone Cypionate Injection · DIN 02496003
Manufacturer: Taro Pharmaceuticals Inc.; listing date 2021-04-30
Health Canada: Marketed since 2020-10-20 · brand TARO-TESTOSTERONE CYPIONATE INJECTION · ATC G03BA03 TESTOSTERONE · form Solution · route Intramuscular · ingredients TESTOSTERONE CYPIONATE 100 MG/ML · company Taro pharmaceuticals inc · schedule Controlled drugs (cdsa iv)
Taro-Testosterone Cypionate Injection: Formulary list price $34.8780/unit (unit not stated in source; not the patient's cost)
Ministry pays: $34.8780 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=98589 · Verify on the e-Formulary ↗ (DIN 02496003)
Source record
DIN 02496003: Taro-Testosterone Cypionate Injection
Raw flags: sec12=Y, sec3=Y
Item: 680800013; group id 724; item number 1787; lccId 00175; manufacturer id TAR
Source form: Oily Inj Sol-10mL Pk; strength: 100mg/mL
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $34.8780; ministry $34.8780
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02496003
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=98589Interchangeable products
Depo-Testosterone · DIN 00030783 · not recorded
Shortage status: resolved shortage (ended 2025-11-25); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02496003
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Listed, not a benefit; Health Canada lists this DIN as Cancelled post market since 2025-07-18 — choose a marketed DIN from the same-category list.Discontinued 2025-07-18 · checked 2026-09-02
StatusListed, not a benefit; Health Canada lists this DIN as Cancelled post market since 2025-07-18 — choose a marketed DIN from the same-category list.
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives; Health Canada lists this DIN as Cancelled post market since 2025-07-18 — choose a marketed DIN from the same-category list.
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 397
Reason for Use code 397
For male patients with confirmed low morning serum testosterone levels associated with documented, symptomatic hypothalamic, pituitary or testicular disease, or in HIV-infected patients.
Note: Older males with nonspecific symptoms of fatigue, malaise, depression who have a low normal random testosterone level do not satisfy these criteria.
Coverage limit:
LU Authorization Period: 1 year
1 brand, same coverage
Depo-Testosterone · DIN 00030783
Manufacturer: Pfizer Canada Inc.; listing date 1996-10-01
Health Canada: Cancelled post market since 2025-07-18 · brand DEPO-TESTOSTERONE INJ 100MG/ML · ATC G03BA03 TESTOSTERONE · form Solution · route Intramuscular · ingredients TESTOSTERONE CYPIONATE 100 MG/ML · company Pfizer canada ulc · schedule Controlled drugs (cdsa iv)
Depo-Testosterone: Formulary list price not recorded/unit (unit not stated in source; not the patient's cost)
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=1398 · Verify on the e-Formulary ↗ (DIN 00030783)
Source record
DIN 00030783: Depo-Testosterone
Raw flags: notABenefit=Y, sec3=Y
Item: 680800013; group id 724; item number 1787; lccId 00175; manufacturer id PFI
Source form: Oily Inj Sol-10mL Pk; strength: 100mg/mL
Recorded listing: Listed, not a benefit; ODB pays only for the benefit products in this interchangeable category
Source prices (unrounded): not recorded; ministry not recorded
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=00030783
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=1398Interchangeable products
Taro-Testosterone Cypionate Injection · DIN 02496003 · $34.8780
Shortage status: discontinued (2025-10-23, reported by PFIZER CANADA ULC); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=00030783
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Health Canada lists this DIN as Cancelled post market since 2025-07-18 — choose a marketed DIN from the same-category list.
Limited Use — Reason for Use code 397 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 397 required
Write on scriptLU code 397 (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 397
Reason for Use code 397
For male patients with confirmed low morning serum testosterone levels associated with documented, symptomatic hypothalamic, pituitary or testicular disease, or in HIV-infected patients.
Note: Older males with nonspecific symptoms of fatigue, malaise, depression who have a low normal random testosterone level do not satisfy these criteria.
Coverage limit:
LU Authorization Period: 1 year
1 brand, same coverage
Testosterone Enanthate Injection, USP · DIN 02536315
Manufacturer: Hikma Canada Limited; listing date 2024-10-31
Health Canada: Marketed since 2024-01-30 · brand TESTOSTERONE ENANTHATE INJECTION, USP · ATC G03BA03 TESTOSTERONE · form Solution · route Intramuscular · ingredients TESTOSTERONE ENANTHATE 200 MG/ML · company Hikma canada limited · schedule Controlled drugs (cdsa iv)
Testosterone Enanthate Injection, USP: Formulary list price $35.5943/unit (unit not stated in source; not the patient's cost)
Ministry pays: $35.5943 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=102510 · Verify on the e-Formulary ↗ (DIN 02536315)
Source record
DIN 02536315: Testosterone Enanthate Injection, USP
Raw flags: sec12=Y, sec3=Y
Item: 680800014; group id 725; item number 1788; lccId 00176; manufacturer id HIK
Source form: Oily Inj Sol-5mL Pk; strength: 1000mg/5mL
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $35.5943; ministry $35.5943
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02536315
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102510Interchangeable products
Delatestryl · DIN 00029246 · not recorded
Shortage status: resolved shortage (ended 2026-05-05); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02536315
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Listed, not a benefit; Health Canada lists this DIN as Cancelled post market since 2025-12-18 — choose a marketed DIN from the same-category list.Discontinued 2025-12-18 · checked 2026-09-02
StatusListed, not a benefit; Health Canada lists this DIN as Cancelled post market since 2025-12-18 — choose a marketed DIN from the same-category list.
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives; Health Canada lists this DIN as Cancelled post market since 2025-12-18 — choose a marketed DIN from the same-category list.
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 397
Reason for Use code 397
For male patients with confirmed low morning serum testosterone levels associated with documented, symptomatic hypothalamic, pituitary or testicular disease, or in HIV-infected patients.
Note: Older males with nonspecific symptoms of fatigue, malaise, depression who have a low normal random testosterone level do not satisfy these criteria.
Coverage limit:
LU Authorization Period: 1 year
1 brand, same coverage
Delatestryl · DIN 00029246
Manufacturer: Valeant Canada Ltd.; listing date 1996-10-01
Health Canada: Cancelled post market since 2025-12-18 · brand DELATESTRYL · ATC G03BA03 TESTOSTERONE · form Solution · route Intramuscular · ingredients TESTOSTERONE ENANTHATE 200 MG/ML · company Bausch health, canada inc. · schedule Controlled drugs (cdsa iv)
Delatestryl: Formulary list price not recorded/unit (unit not stated in source; not the patient's cost)
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=1275 · Verify on the e-Formulary ↗ (DIN 00029246)
Source record
DIN 00029246: Delatestryl
Raw flags: notABenefit=Y, sec3=Y
Item: 680800014; group id 725; item number 1788; lccId 00176; manufacturer id VAL
Source form: Oily Inj Sol-5mL Pk; strength: 1000mg/5mL
Recorded listing: Listed, not a benefit; ODB pays only for the benefit products in this interchangeable category
Source prices (unrounded): not recorded; ministry not recorded
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=00029246
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=1275Interchangeable products
Testosterone Enanthate Injection, USP · DIN 02536315 · $35.5943
Shortage status: discontinued (2024-04-25, reported by BAUSCH HEALTH, CANADA INC.); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=00029246
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Health Canada lists this DIN as Cancelled post market since 2025-12-18 — choose a marketed DIN from the same-category list.
TESTOSTERONE UNDECANOATE
1 Limited Use · 1 not a benefit
Taro-Testosterone · DIN 02421186 · 40mg · capsule
Limited Use — Reason for Use code 397 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 397 required
Write on scriptLU code 397 (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 397
Reason for Use code 397
For male patients with confirmed low morning serum testosterone levels associated with documented, symptomatic hypothalamic, pituitary or testicular disease, or in HIV-infected patients.
Note: Older males with nonspecific symptoms of fatigue, malaise, depression who have a low normal random testosterone level do not satisfy these criteria.
Coverage limit:
LU Authorization Period: 1 year
1 brand, same coverage
Taro-Testosterone · DIN 02421186
Manufacturer: Taro Pharmaceuticals Inc.; listing date 2014-10-29
Health Canada: Marketed since 2014-09-02 · brand TARO-TESTOSTERONE · ATC G03BA03 TESTOSTERONE · form Capsule · route Oral · ingredients TESTOSTERONE UNDECANOATE 40 MG · company Taro pharmaceuticals inc · schedule Controlled drugs (cdsa iv)
Taro-Testosterone: Formulary list price $0.5649/unit (unit not stated in source; not the patient's cost)
Ministry pays: $0.5649 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=90578 · Verify on the e-Formulary ↗ (DIN 02421186)
Source record
DIN 02421186: Taro-Testosterone
Raw flags: sec12=Y, sec3=Y
Item: 680800025; group id 726; item number 1789; lccId 00177; manufacturer id TAR
Source form: Cap; strength: 40mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $0.5649; ministry $0.5649
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02421186
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=90578Interchangeable products
Andriol · DIN 00782327 · not recorded
Shortage status: resolved shortage (ended 2026-06-10); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02421186
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Andriol · DIN 00782327 · 40mg · capsule
Listed, not a benefit; Health Canada lists this DIN as Cancelled post market since 2018-01-29 — choose a marketed DIN from the same-category list.Discontinued 2018-01-29 · checked 2026-09-02
StatusListed, not a benefit; Health Canada lists this DIN as Cancelled post market since 2018-01-29 — choose a marketed DIN from the same-category list.
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives; Health Canada lists this DIN as Cancelled post market since 2018-01-29 — choose a marketed DIN from the same-category list.
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 397
Reason for Use code 397
For male patients with confirmed low morning serum testosterone levels associated with documented, symptomatic hypothalamic, pituitary or testicular disease, or in HIV-infected patients.
Note: Older males with nonspecific symptoms of fatigue, malaise, depression who have a low normal random testosterone level do not satisfy these criteria.
Coverage limit:
LU Authorization Period: 1 year
1 brand, same coverage
Andriol · DIN 00782327
Manufacturer: Organon Canada Ltd./Ltee; listing date 1996-10-01
Health Canada: Cancelled post market since 2018-01-29 · brand ANDRIOL · ATC G03BA03 TESTOSTERONE · form Capsule · route Oral · ingredients TESTOSTERONE UNDECANOATE 40 MG · company Merck canada inc · schedule Controlled drugs (cdsa iv)
Andriol: Formulary list price not recorded/unit (unit not stated in source; not the patient's cost)
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=13411 · Verify on the e-Formulary ↗ (DIN 00782327)
Source record
DIN 00782327: Andriol
Raw flags: notABenefit=Y, sec3=Y
Item: 680800025; group id 726; item number 1789; lccId 00177; manufacturer id ORG
Source form: Cap; strength: 40mg
Recorded listing: Listed, not a benefit; ODB pays only for the benefit products in this interchangeable category
Source prices (unrounded): not recorded; ministry not recorded
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=00782327
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=13411Interchangeable products
Taro-Testosterone · DIN 02421186 · $0.5649
Shortage status: discontinued (2018-01-29, reported by MERCK CANADA INC); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=00782327
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Health Canada lists this DIN as Cancelled post market since 2018-01-29 — choose a marketed DIN from the same-category list.
Other drugs in the same formulary class (68:08 Androgens) and how they are covered
Matched class: 68:08 Androgens
Drug-class inventory only. Lists recorded Ontario formulary products, not every Canadian medication; does not recommend treatment.
Covered without a code on the Ontario formulary: DANAZOL
68:08 Androgens
1 INDICATIONS
ANDROGEL (testosterone) is indicated for:
• testosterone replacement therapy in adult males for conditions associated with a deficiency or
absence of endogenous testosterone (hypogonadism).
ANDROGEL should not be used to treat non-specific symptoms suggestive of hypogonadism if
testosterone deficiency has not been demonstrated and if other etiologies responsible for the
symptoms have not been excluded. Testosterone deficiency should be clearly demonstrated by clinical
features and confirmed by biochemical assays (Endocrine Society Guidelines recommend two separate
tests preferably in the morning) before initiating therapy with any testosterone replacement, including
ANDROGEL treatment. Due to variability in laboratory values, all measures of testosterone should be
carried out in the same laboratory.
1.1 Pediatrics
ANDROGEL is not indicated for use in children < 18 years of age since safety and efficacy have not been
established in this patient population (see 7.1.3 Pediatrics).
1.2 Geriatrics
There are limited controlled clinical study data supporting the use of ANDROGEL in the geriatric
population (see 7 WARNINGS AND PRECAUTIONS…
https://pdf.hres.ca/dpd_pm/00081277.PDF
PM date: FEB 06, 2002
Source product: ANDROGEL; DIN 02245345; fetched 2026-09-10
Product monograph posted by Health Canada; excerpt for lookup only.
What the Health Canada label says it is for
INDICATIONS AND CLINICAL USE
TARO–TESTOSTERONE CYPIONATE INJECTION (testosterone cypionate injection) is
indicated for testosterone replacement therapy in adult males for conditions associated with a
deficiency or absence of endogenous testosterone (hypogonadism).
TARO–TESTOSTERONE CYPIONATE INJECTION (testosterone cypionate injection)
should not be used to treat non- specific symptoms suggestive of hypogonadism if testosterone
deficiency has not been demonstrated and if other etiologies responsible for the symptoms have
not been excluded. Testosterone deficiency should be clearly demonstrated by clinical features
and confirmed by two separate validated biochemical assays (morning testosterone) before
initiating therapy with any testosterone replacement, including TARO–TESTOSTERONE
CYPIONATE INJECTION treatment.
Safety and efficacy of testosterone cypionate injection in men with “age- related
hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.
Ge riatrics (> 65 ye ars of age ):
There are no controlled clinical trial data to support the use of testosterone cypionate injection
in the geriatric population (see WARNINGS AND PRECAUTIONS – Spe cia…
https://pdf.hres.ca/dpd_pm/00066102.PDF
PM date: May 26, 2022
Source product: TARO-TESTOSTERONE CYPIONATE INJECTION; DIN 02496003; fetched 2026-09-10
Product monograph posted by Health Canada; excerpt for lookup only.
What the Health Canada label says it is for
INDICATIONS AND CLINICAL USE
Testosterone Enanthate Injection, USP (testosterone enanthate) is indicated for testosterone
replacement therapy in adult males for conditions associated with a deficiency or absence of
endogenous testosterone (hypogonadism).
Testosterone Enanthate Injection, USP should not be used to treat non-specific symptoms suggestive
of hypogonadism if testosterone deficiency has not been demonstrated and if other etiologies
responsible for the symptoms have not been excluded. Testosterone deficiency should be clearly
demonstrated by clinical features and confirmed by two separate biochemical assays (morning
testosterone) before initiating therapy with any testosterone replacement, including Testosterone
Enanthate Injection, USP treatment.
Geriatrics (> 65 years of age):
There are limited controlled clinical study data supporting the use of testosterone enanthate in the
geriatric population (see WARNINGS AND PRECAUTIONS and CLINICAL TRIALS).
Pediatrics (< 18 years of age):
Testosterone Enanthate Injection, USP is not indicated for use in children < 18 years of age since
safety and …
https://pdf.hres.ca/dpd_pm/00071616.PDF
PM date: not printed or not captured
Source product: TESTOSTERONE ENANTHATE INJECTION, USP; DIN 02536315; fetched 2026-09-10
Product monograph posted by Health Canada; excerpt for lookup only.
What the Health Canada label says it is for
INDICATIONS AND CLINICAL USE
Taro-Testosterone (testosterone undecanoate capsules) is indicated for testosterone replacement
therapy in adult males for conditions associated with a deficiency or absence of endogenous
testosterone.
Taro-Testosterone should not be used to treat non-specific symptoms suggestive of hypogonadism if
testosterone deficiency has not been demonstrated and if other etiologies responsible for the symptoms
have not been excluded. Testosterone deficiency should be clearly demonstrated by clinical features
and confirmed by two separate validated biochemical assays (morning testosterone) before initiating
therapy with any testosterone replacement, including Taro-Testosterone treatment.
Geriatrics (> 65 years of age): There is limited Taro-Testosterone use in the geriatric population. (see
CLINICAL TRIALS)
Pediatrics (< 18 years of age): Taro-Testosterone is not indicated for use in children < 18 years of
age since safety and efficacy have not been established in this patient population (see WARNINGS
AND PRECAUTIONS)
Taro-Testosterone (testosterone undecanoate capsules) 40 mg Page 3 of 28
https://pdf.hres.ca/dpd_pm/00048154.PDF
PM date: not printed or not captured
Source product: TARO-TESTOSTERONE; DIN 02421186; fetched 2026-09-10
Product monograph posted by Health Canada; excerpt for lookup only.
Availability
Taro-Testosterone Gel · DIN 02463792
Shortage status: active shortage (reported 2026-08-27, estimated to end 2026-10-03, last updated 2026-09-04); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02463792
For Depo-Testosterone, Delatestryl, Andriol: no applicable EAP criteria are held and no ODB benefit is established. These policies do not establish coverage.
For rare, immediately life-, limb- or organ-threatening circumstances, the Compassionate Review Policy may consider an unfunded drug or indication, subject to its criteria and without bypassing the drug review process. Compassionate Review Policy
Compassionate Review Policy: source quote
Where there are rare clinical circumstances in immediately life, limb, or organ-threatening conditions, the Executive Officer will also consider requests for drugs or indications in situations where there has not been a decision by the Executive Officer to provide funding of the drug or indication as part of the Ontario Drug Benefit program (and the EAP), and the drug or indication requested would not circumvent the established review process for new drugs or indications as part of the drug submission process for listing within the Ontario Drug Benefit program. Requests must meet the criteria for the Compassionate Review Policy.
For cancer drugs, Case-by-Case Review considers rare, immediately life-threatening circumstances when no satisfactory funded treatment exists; its criteria and application process apply. Case-by-Case Review (cancer drugs)
Case-by-Case Review (cancer drugs): source quote
Note: Requests for cancer drugs are considered under the Case-by-Case Review Program (CBCRP) which is administered by Ontario Health (Cancer Care Ontario) on behalf of the Ministry of Health. The CBCRP considers funding requests for drugs (both oral therapies and injectable drugs) for the treatment of cancer in patients who have a rare clinical circumstance that is immediately life-threatening (death is likely within a matter of months) and who require treatment with an unfunded drug, because there is no other satisfactory and funded treatment. Please refer to the Ontario Health website for information on the application process, FAQs, eligibility criteria and program policies.