Sandoz Guanfacine XR · DIN 02563207 · 3mg · extended release tablet
Limited Use — Reason for Use code 540 requiredMarketed · checked 2026-09-20
StatusLimited Use — Reason for Use code 540 required
Write on scriptLU code 540 (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 540
Reason for Use code 540
For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 to 17 years who meet the following criteria:
(i) As adjunctive therapy to psychostimulants; OR
(ii) As monotherapy in patients who have significant intolerance to psychostimulants AND who have had an inadequate response to either atomoxetine or other non-stimulant alternative(s).
Coverage limit:
LU Authorization Period: 1 year
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 Guanfacine XR · DIN 02563207
Manufacturer: Sandoz Canada Inc.; listing date 2026-05-29
Health Canada: Marketed since 2026-04-30 · brand SANDOZ GUANFACINE XR · ATC C02AC02 GUANFACINE · form Tablet (extended-release) · route Oral · ingredients GUANFACINE (GUANFACINE HYDROCHLORIDE) 3 MG · company Sandoz canada incorporated · schedule Prescription
Sandoz Guanfacine XR: Formulary list price $1.1019/unit (unit not stated in source; not the patient's cost)
Ministry pays: $1.1019 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=106601 · Verify on the e-Formulary ↗ (DIN 02563207)
Source record
DIN 02563207: Sandoz Guanfacine XR
Raw flags: sec12=Y, sec3=Y
Item: 240816003; group id 360; item number 0842; lccId 00326; manufacturer id SDZ
Source form: ER Tab; strength: 3mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $1.1019; ministry $1.1019
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02563207
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=106601
Interchangeable products
Apo-Guanfacine XR · DIN 02523744 · $1.1019
Intuniv XR · DIN 02409127 · $1.1019
Jamp Guanfacine XR · DIN 02523574 · $1.1019
Shortage status: not checked (no credentials)