SINGULAIR 10 MG
MONTELUKAST (MONTELUKAST SODIUM) : 10 MG · DIN 02238217 · ORGANON CANADA INC.
Health Canada status: MARKETED
What is SINGULAIR?
SINGULAIR 10 MG contains MONTELUKAST (MONTELUKAST SODIUM) : 10 MG. It is listed in the Health Canada Drug Product Database under DIN 02238217, held by ORGANON CANADA INC., supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 23-Sep-2022. 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 SINGULAIR used for?
Prophylaxis and chronic treatment of asthma (2+ years); exercise-induced bronchoconstriction (2+ years); seasonal allergic rhinitis (15+ years) 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.
What else is SINGULAIR called?
The same molecule, MONTELUKAST, is registered under other names elsewhere. Buyers and prescribers searching from outside Canada — or working from a foreign prescription or tender document — often know it by one of these:
| Name | Script | Registered in |
|---|---|---|
| Montelukast Viatris | Latin | Australia, Czechia, Sweden |
| Montelukast Teva | Latin | Czechia, Sweden |
| MONTELAR | Latin | Czechia |
| Montelukast Krka | Latin | Sweden |
| Montelukast Sandoz | Latin | Sweden |
| Singulair® | Latin | Sweden |
| CASTISPIR | Latin | Czechia |
| MONKASTA | Latin | Czechia |
| Montelukast Accord | Latin | Sweden |
| Montelukast STADA | Latin | Sweden |
| MONTELUKAST MYLAN | Latin | Czechia |
| APX-MONTELUKAST | Latin | Australia |
| Montelukast Lupin | Latin | Australia |
| MONTELUKAST MEDREG | Latin | Czechia |
| MONTELUKAST-WGR | Latin | Australia |
Names are taken from national medicine registers and published price lists. A product registered abroad is not authorized for sale in Canada unless it holds its own DIN; import is possible only through the routes Health Canada permits.
Product details and regulatory record
| DIN | 02238217 |
|---|---|
| Brand name | SINGULAIR |
| Generic / active ingredient | MONTELUKAST (MONTELUKAST SODIUM) : 10 MG |
| Manufacturer | ORGANON CANADA INC. |
| Strength | 10 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | R03DC03 MONTELUKAST |
| AHFS class | 84:28.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 23-Sep-2022 |
| Original market date | 1998-08-24 00:00:00 |
How is this product identified?
Purchase orders, customs paperwork and tender documents each ask for a different identifier, and a DIN written without its leading zeros is the single most common reason an order line fails to match. Every form Nexara accepts for this product is listed here.
| DIN (8-digit, as used in Nexara ordering) | 02238217 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2238217 |
| Brand name | SINGULAIR |
| Active ingredient / INN | MONTELUKAST (MONTELUKAST SODIUM) : 10 MG |
| ATC code | R03DC03 |
| ATC anatomical main group | R — Respiratory system |
| ATC therapeutic subgroup | R03 |
| AHFS class | 84:28.00 |
| Health Canada schedule | Prescription |
| Biosimilar biologic | No |
| Market authorization holder | ORGANON CANADA INC. |
How is it administered?
Adults (15+): 10 mg tablet daily. Children 6-14: 5 mg chewable tablet daily. Children 2-5: 4 mg chewable tablet or granules daily. Take in evening with or without food.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly detailed in provided text (refers to STORAGE AND STABILITY section on page 18, which is not in the snippet).
How is it supplied?
Not explicitly detailed in provided text (refers to packets for granules).
Which pack is which?
| Strength on the label | 10 MG |
|---|---|
| Dosage form | TABLET |
| Route | ORAL |
| Packaging as described in the monograph | Not explicitly detailed in provided text (refers to packets for granules). |
| Storage | Not explicitly detailed in provided text (refers to STORAGE AND STABILITY section on page 18, which is not in the snippet). |
One DIN can cover more than one pack size, and the pack — not the DIN — is what gets priced, shipped and invoiced. Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Contraindications
Hypersensitivity to this drug or to any ingredient in the formulation.
Warnings and precautions
WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS (agitation, depression, suicidal thoughts). Not for acute asthma attacks. Potential for eosinophilic conditions (EGPA). Caution in phenylketonurics.
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 much does MONTELUKAST cost around the world?
MONTELUKAST is listed on 15 national price registers Nexara tracks, across 380 pack listings published on 14 different price bases. What each country publishes is set out below.
| Market | What that country publishes | Brands listed | Pack listings | As of |
|---|---|---|---|---|
| South Africa | single exit price | 53 | 64 | 01 Sep 2026 |
| Italy | prezzo al pubblico (classe A) | 26 | 59 | 02 Sep 2026 |
| Czechia | max producer price (ex-factory) | 10 | 51 | 03 Sep 2026 |
| Sweden | AIP (pharmacy purchase price) | 11 | 46 | 03 Sep 2026 |
| Greece | producer price (ex-factory) | 34 | 34 | 03 Sep 2026 |
| Austria | KVP (Kassenverkaufspreis) | 25 | 26 | 03 Sep 2026 |
| Slovakia | categorised final price | 17 | 26 | 02 Sep 2026 |
| Australia | ex-manufacturer | 8 | 24 | 08 Sep 2026 |
| Romania | max producer price | 11 | 15 | 03 Sep 2026 |
| Hungary | producer price (ex-factory) | 12 | 12 | 03 Sep 2026 |
| Luxembourg | reimbursement | 8 | 8 | 05 Sep 2026 |
| Spain | PVP con IVA (public price) | 5 | 5 | 05 Sep 2026 |
| Morocco | PPV (public price) | 1 | 5 | 05 Sep 2026 |
| United Kingdom | hospital | 4 | 4 | 31 Aug 2026 |
| Bahrain | retail (max) | 1 | 1 | 01 Sep 2026 |
Why there are no figures here. These bases are not comparable. A Brazilian ex-factory ceiling, a Belgian pharmacy public price and a Japanese reimbursement rate answer three different questions, and none of them is what a product lands in Canada for. Putting them side by side would mislead in both directions, so Nexara publishes where a molecule is listed and on what basis, and quotes the delivered Canadian price per 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.