SPC-MONTELUKAST 10 MG
MONTELUKAST (MONTELUKAST SODIUM) : 10 MG · DIN 02389517 · SUN PHARMA CANADA INC
Health Canada status: MARKETED
What is SPC-MONTELUKAST?
SPC-MONTELUKAST 10 MG contains MONTELUKAST (MONTELUKAST SODIUM) : 10 MG. It is listed in the Health Canada Drug Product Database under DIN 02389517, held by SUN PHARMA CANADA INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 15-Apr-2025. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.
What is SPC-MONTELUKAST used for?
Prophylaxis and chronic treatment of asthma (15+ years); exercise-induced bronchoconstriction; relief of seasonal allergic rhinitis symptoms when other treatments are ineffective/not tolerated.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Product details and regulatory record
| DIN | 02389517 |
|---|---|
| Brand name | SPC-MONTELUKAST |
| Generic / active ingredient | MONTELUKAST (MONTELUKAST SODIUM) : 10 MG |
| Manufacturer | SUN PHARMA CANADA INC |
| Strength | 10 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | R03DC03 MONTELUKAST |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 15-Apr-2025 |
How is it administered?
Adults 15+: One 10 mg tablet daily taken in the evening. Can be taken with or without food. For asthma, take daily even when asymptomatic.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly detailed in provided text (Table of Contents lists section but text cuts off).
How is it supplied?
Not explicitly detailed in provided text beyond "10 mg tablets" and "film-coated".
Contraindications
Hypersensitivity to this drug or to any ingredient in the formulation.
Warnings and precautions
WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS (agitation, aggression, depression, sleep disturbances, suicidal thoughts/behavior). Not for acute asthma attacks. Risk of eosinophilic conditions (EGPA).
What can be used instead?
Other Canadian products sharing ATC code R03DC03 MONTELUKAST. 41 of 97 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.
| Product | Strength | Form | Manufacturer | Health Canada status | DIN |
|---|---|---|---|---|---|
| ACH-MONTELUKAST | 10 MG | TABLET | ACCORD HEALTHCARE INC | MARKETED | DIN 02379236 |
| AG-MONTELUKAST | 10 MG | TABLET | ANGITA PHARMA INC. | MARKETED | DIN 02482835 |
| APO-MONTELUKAST | 10 MG | TABLET | APOTEX INC | MARKETED | DIN 02374609 |
| APO-MONTELUKAST | 4 MG | TABLET (CHEWABLE) | APOTEX INC | MARKETED | DIN 02377608 |
| APO-MONTELUKAST | 5 MG | TABLET (CHEWABLE) | APOTEX INC | MARKETED | DIN 02377616 |
| AURO-MONTELUKAST | 10 MG | TABLET | AURO PHARMA INC | MARKETED | DIN 02401274 |
| AURO-MONTELUKAST CHEWABLE TABLET | 4 MG | TABLET (CHEWABLE) | AURO PHARMA INC | MARKETED | DIN 02422867 |
| AURO-MONTELUKAST CHEWABLE TABLET | 5 MG | TABLET (CHEWABLE) | AURO PHARMA INC | MARKETED | DIN 02422875 |
| BIO-MONTELUKAST | 10 MG | TABLET | BIOMED PHARMA | MARKETED | DIN 02445735 |
| JAMP MONTELUKAST CHEWABLE TABLETS | 4 MG | TABLET (CHEWABLE) | JAMP PHARMA CORPORATION | MARKETED | DIN 02514877 |
Who else supplies MONTELUKAST worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. MONTELUKAST appears in 1299 registered pack listings across 14 markets, published on 11 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.
Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.
How can I get it?
Nexara Health supplies this product to licensed Canadian buyers — pharmacies, hospitals, clinics, licensed distributors, and clinical trial sponsors or their CROs. We confirm stock, pack size, expiry and pricing at the time of quotation. If the product is on backorder or in shortage, we identify equivalent alternatives and import options where permitted.
Ordering questions
Who can buy this from Nexara?
Licensed entities only. Nexara holds Health Canada establishment licence DEL 3-002896-A and ships only to a licensed address.
Is there a minimum order?
Yes, set per product line and per pack multiple rather than on the order total, so you are never asked to buy a part-pack. The minimum for this line is confirmed with your quote.
What is the lead time?
Confirmed per order at quotation, and it depends on current stock position and whether the product is in shortage.
Can Nexara supply this for a clinical trial?
Yes — comparator and background-therapy supply, including sourcing from other markets where a Canadian pack will not satisfy the protocol. Clinical trial supply.