Look up one drug

Reason for Use code 382 For the treatment of asthma in patients aged 2-5 years old. Coverage limit: LU Authorization Period: 1 year Exceptional Access criteria on record are for Brand(s): Singulair; DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Montelukast Brand(s): Singulair DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet Updated criteria: October 28, 2010 For the treatment of asthma patients who cannot manage the use of an inhalation device despite assistance with a spacer (e.g. physically or mentally disabled patients or pediatric patients). Duration of Approval: 5 years OR For the treatment of asthma in children and adolescents whose asthma cannot be controlled on ICS alone and where the condition remains uncontrolled despite using full doses of ICS with addition of LABA, and with assurance of good adherence and inhaler technique Duration of Approval: 5 years (up until age of 18) Renewal of requests that meet the above criteria will be provided where the following apply: • Current medications and dosages must be clearly specified; AND Objective evidence of positive response from treatment (spirometry OR decrease in health care utilization) must be provided Duration of Approval: 5 years (up until age of 18) 65 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 65, record 42, corpus 2025-01-01; name match only, not an eligibility decision

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 ↗)

Sandoz Montelukast · DIN 02330385 Manufacturer: Sandoz Canada Inc.; listing date 2012-01-19 Health Canada: Marketed since 2011-10-11 · brand SANDOZ MONTELUKAST · ATC R03DC03 MONTELUKAST · form Tablet (chewable) · route Oral · ingredients MONTELUKAST (MONTELUKAST SODIUM) 4 MG · company Sandoz canada incorporated · schedule Prescription

DIN 02330385: Sandoz Montelukast Raw flags: sec12=Y, sec3=Y Item: 920000406; group id 935; item number 2229; lccId 00154; manufacturer id SDZ Source form: Chew Tab; strength: 4mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $0.2758; ministry $0.2758 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02330385 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=81612

Interchangeable products

Apo-Montelukast · DIN 02377608 · $0.2758 Auro-Montelukast Chewable Tablet · DIN 02422867 · $0.2758 Jamp Montelukast Chewable Tablets · DIN 02514877 · $0.2758 Jamp-Montelukast · DIN 02442353 · $0.2758 Mar-Montelukast · DIN 02399865 · $0.2758 Mint-Montelukast · DIN 02408627 · $0.2758 Montelukast · DIN 02382458 · $0.2758 Nat-Montelukast · DIN 02522101 · $0.2758 PMS-Montelukast · DIN 02354977 · $0.2758 Singulair · DIN 02243602 · $0.2758 Teva-Montelukast · DIN 02355507 · $0.2758

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=02330385

Shortage record checked 2026-09-13T08:10:21.292534+00:00