ACH-MONTELUKAST 4 MG — DIN 02410265
MONTELUKAST (MONTELUKAST SODIUM) : 4 MG · ACCORD HEALTHCARE INC · TABLET (CHEWABLE) · wholesale supply in Canada
Health Canada status: CANCELLED POST MARKET
What is ACH-MONTELUKAST?
ACH-MONTELUKAST 4 MG contains MONTELUKAST (MONTELUKAST SODIUM) : 4 MG. It is listed in the Health Canada Drug Product Database under DIN 02410265, held by ACCORD HEALTHCARE INC, supplied as TABLET (CHEWABLE) for ORAL administration. Health Canada currently lists it as cancelled post market, status dated 07-Aug-2017. This Drug Identification Number is no longer authorized for sale in Canada, so Nexara does not supply it. The record is kept here because buyers still meet the number on old formularies, purchase orders and tender documents; Nexara can help identify an authorized alternative.
What is ACH-MONTELUKAST used for?
Prophylaxis and chronic treatment of asthma in pediatric patients 2 years and older, including prevention of day/night symptoms, ASA-sensitive asthma, and exercise-induced bronchoconstriction.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Montelukast cost around the world?
Montelukast is listed on 15 of the national price registers Nexara ingests. Each country publishes on a different basis, so those figures are not comparable with one another — or with a Canadian wholesale price.
What a market publishes matters more than the number it publishes. Australia publishes a ex-manufacturer; Austria publishes a KVP (Kassenverkaufspreis); Bahrain publishes a retail (max). Comparing an ex-factory ceiling against a pharmacy public price tells you nothing about either, and comparing either against a Canadian landed cost tells you less.
| Market | Price basis published there | Brands | Packs listed | Range |
|---|---|---|---|---|
| South Africa | single exit price | 53 | 64 | ZAR███.██ |
| Italy | prezzo al pubblico (classe A) | 26 | 59 | EUR███.██ |
| Czechia | max producer price (ex-factory) | 10 | 51 | CZK███.██ |
| Sweden | AIP (pharmacy purchase price) | 11 | 46 | SEK███.██ |
| Greece | producer price (ex-factory) | 34 | 34 | EUR███.██ |
| Austria | KVP (Kassenverkaufspreis) | 25 | 26 | EUR███.██ |
| Slovakia | categorised final price | 17 | 26 | EUR███.██ |
| Australia | ex-manufacturer | 8 | 24 | AUD███.██ |
| Romania | max producer price | 11 | 15 | RON███.██ |
| Hungary | producer price (ex-factory) | 12 | 12 | HUF███.██ |
| Luxembourg | reimbursement | 8 | 8 | EUR███.██ |
| Spain | PVP con IVA (public price) | 5 | 5 | EUR███.██ |
| Morocco | PPV (public price) | 1 | 5 | MAD███.██ |
| United Kingdom | hospital | 4 | 4 | GBP███.██ |
| Bahrain | retail (max) | 1 | 1 | BHD███.██ |
380 pack listings across 226 brand entries and 14 price bases, refreshed 08 Sep 2026. Ranges span every Montelukast pack in that market, so a high figure is usually a larger pack rather than the same product.
This table is a regulatory record of where the molecule is listed. The DIN on this page is no longer authorized for sale in Canada, so Nexara does not quote it — see the alternatives above.
Is there a generic Montelukast in Canada, and who makes it?
Every market authorization holder with a Canadian DIN for this molecule, and how many of their listings Health Canada currently shows as marketed.
29 holders have a Canadian DIN containing Montelukast, across 97 DINs, of which 41 are currently marketed. Marketed count is the number that matters: an approval that is not marketed cannot be bought.
| Market authorization holder | DINs | Marketed | Brand names | Position |
|---|---|---|---|---|
| SANDOZ CANADA INCORPORATED | 4 | 4 | SANDOZ MONTELUKAST | Sourceable in Canada |
| TEVA CANADA LIMITED | 9 | 3 | NTP-MONTELUKAST, RATIO-MONTELUKAST, TEVA-MONTELUKAST | Sourceable in Canada |
| APOTEX INC | 6 | 3 | APO-MONTELUKAST, APO-MONTELUKAST SODIUM, APO-MONTELUKAST SODIUM CHEWABLE | Sourceable in Canada |
| JAMP PHARMA CORPORATION | 5 | 3 | JAMP MONTELUKAST CHEWABLE TABLETS, JAMP-MONTELUKAST | Sourceable in Canada |
| ORGANON CANADA INC. | 4 | 3 | SINGULAIR | Sourceable in Canada |
| AURO PHARMA INC | 3 | 3 | AURO-MONTELUKAST, AURO-MONTELUKAST CHEWABLE TABLET | Sourceable in Canada |
| MINT PHARMACEUTICALS INC | 3 | 3 | MINT-MONTELUKAST | Sourceable in Canada |
| PHARMASCIENCE INC | 3 | 3 | PMS-MONTELUKAST, PMS-MONTELUKAST FC | Sourceable in Canada |
| PRO DOC LIMITEE | 3 | 3 | MONTELUKAST | Sourceable in Canada |
| SIVEM PHARMACEUTICALS ULC | 3 | 3 | MONTELUKAST | Sourceable in Canada |
| SANIS HEALTH INC | 3 | 2 | MONTELUKAST | Sourceable in Canada |
| MARCAN PHARMACEUTICALS INC | 6 | 1 | IPG-MONTELUKAST, MAR-MONTELUKAST | Sourceable in Canada |
Health Canada’s Drug Product Database does not flag which listing is the originator and which are subsequent-entry products, so Nexara does not label them here. Interchangeability is determined provincially, not federally — confirm for your province before a formulary switch. Nexara can confirm which of these is actually obtainable, and on what lead time, per order.
How is it supplied and stored?
Pack configuration, storage class and the handling constraints that drive cold-chain planning. One DIN can cover more than one pack size, and the pack — not the DIN — is what gets priced, shipped and invoiced.
| Strength on the label | 4 MG |
|---|---|
| Dosage form | TABLET (CHEWABLE) |
| Route | ORAL |
| Pack configuration (monograph) | Not explicitly detailed in the provided text (mentions 4 mg and 5 mg strengths). |
| Storage | Not explicitly detailed in the provided text (Table of Contents lists section 15, but text ends at section 12). |
Pack detail is kept as a regulatory record. This DIN is no longer authorized for sale in Canada, so Nexara does not quote this pack.
Substance and classification
| Active substance | Montelukast |
|---|---|
| ATC code | R03DC03 |
| AHFS class | 48:10.24 |
| Biosimilar biologic | No |
Health Canada record and identifiers
The regulatory facts straight from the Drug Product Database, plus every identifier form Nexara accepts on a purchase order. A DIN written without its leading zeros is the commonest reason an order line fails to match.
| DIN (8-digit, as used in ordering) | 02410265 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2410265 |
| Brand name | ACH-MONTELUKAST |
| Generic / active ingredient | MONTELUKAST (MONTELUKAST SODIUM) : 4 MG |
| Market authorization holder | ACCORD HEALTHCARE INC |
| Health Canada schedule | Prescription |
| ATC code | R03DC03 |
| ATC anatomical main group | R — Respiratory system |
| ATC therapeutic subgroup | R03DC |
| Current status | CANCELLED POST MARKET |
| Status date | 07-Aug-2017 |
| Original market date | 2014-06-09 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Pediatrics 6-14 years: one 5 mg chewable tablet daily in the evening. Pediatrics 2-5 years: one 4 mg chewable tablet daily in the evening. Can be taken with or without food.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity to this drug or to any ingredient in the formulation.
Warnings and precautions
Not for acute asthma attacks. Neuropsychiatric events (suicidality, agitation). Potential for systemic eosinophilia (Churg-Strauss syndrome). Contains phenylalanine (aspartame).
What can be used instead?
Alternatives on every axis a buyer actually considers — the same molecule in another presentation, the same class, an adjacent class, or a fixed-dose combination. Every row is led by the marketed DIN count, because that is what can be bought this week.
1 · Same molecule, other Canadian presentations
41 of 97 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| ACH-MONTELUKAST | 10 MG | TABLET | ACCORD HEALTHCARE INC | MARKETED | 02379236 |
| AG-MONTELUKAST | 10 MG | TABLET | ANGITA PHARMA INC. | MARKETED | 02482835 |
| APO-MONTELUKAST | 4 MG | TABLET (CHEWABLE) | APOTEX INC | MARKETED | 02377608 |
| APO-MONTELUKAST | 5 MG | TABLET (CHEWABLE) | APOTEX INC | MARKETED | 02377616 |
| APO-MONTELUKAST | 10 MG | TABLET | APOTEX INC | MARKETED | 02374609 |
| AURO-MONTELUKAST | 10 MG | TABLET | AURO PHARMA INC | MARKETED | 02401274 |
| AURO-MONTELUKAST CHEWABLE TABLET | 4 MG | TABLET (CHEWABLE) | AURO PHARMA INC | MARKETED | 02422867 |
| AURO-MONTELUKAST CHEWABLE TABLET | 5 MG | TABLET (CHEWABLE) | AURO PHARMA INC | MARKETED | 02422875 |
| BIO-MONTELUKAST | 10 MG | TABLET | BIOMED PHARMA | MARKETED | 02445735 |
| JAMP MONTELUKAST CHEWABLE TABLETS | 4 MG | TABLET (CHEWABLE) | JAMP PHARMA CORPORATION | MARKETED | 02514877 |
2 · Same class — other molecules in ATC R03DC
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Montelukast | ACCEL-MONTELUKAST SODIUM TABLETS · ACH-MONTELUKAST · AG-MONTELUKAST · APO-MONTELUKAST · +34 more | 97 | 41 | Yes |
| Zafirlukast | ACCOLATE TAB 20 MG | 1 | 0 | Not in Canada |
A molecule with zero marketed DINs cannot be sourced domestically, however many approvals it holds — if one of these sits on a formulary or in an older protocol, that is the line to check.
3 · Adjacent classes in ATC R03D
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| R03DX | Benralizumab · Mepolizumab · Omalizumab · Reslizumab · Roflumilast · +1 more | 19 | 17 |
| R03DA | Aminophylline · Choline Theophyllinate · Diprophylline · Theophylline · Theophylline, Combinations Excl. Psycholeptics | 82 | 8 |
| R03DB | Theophylline And Adrenergics | 1 | 0 |
Not clinical advice. These tables describe what can be supplied in Canada, not what should be prescribed. Substitution within or across classes is a prescriber and pharmacist decision, and interchangeability is determined provincially.
What else is ACH-MONTELUKAST 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 |
| Singulair | Latin | Czechia, Morocco, 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 |
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.
What is Montelukast called in other languages?
Buyers, prescribers and procurement teams outside Canada often search for the ingredient in their own script. These are phonetic renderings of the ingredient name Montelukast, published to help those searches reach this page.
| Language | Montelukast |
|---|---|
| Arabic العربية | مونتيلوكاست |
| Chinese (Simplified) 简体中文 | 孟鲁司特 |
| Russian Русский | монтелукаст |
| Spanish Español | montelukast |
| Portuguese Português | montelucaste |
| German Deutsch | Montelukast |
| Hindi हिन्दी | मोंटेलुकास्ट |
| Turkish Türkçe | montelukast |
| Japanese 日本語 | モンテルカスト |
| Thai ไทย | มอนเทลูคาสต์ |
| Vietnamese Tiếng Việt | montelukast |
| Indonesian Bahasa Indonesia | montelukast |
| Polish Polski | montelukast |
| Italian Italiano | montelukast |
These are transliterations of the ingredient name, generated automatically and published only where two independent checks agreed. They are not registered local trade names and carry no marketing authorisation in any market. Always confirm a product against its local registration before ordering.
Can this still be bought in Canada?
No. This Drug Identification Number is cancelled post market in Health Canada's Drug Product Database, so the product is no longer authorized for sale in Canada and Nexara does not supply it. This page is kept as a regulatory record.
If you are looking for a current equivalent, the alternatives above list every product sharing this therapeutic class, with the marketed ones first. Ask us to source an alternative
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. Patients and unlicensed buyers are routed to a partner pharmacy.
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.
Why is there no price on this page?
Nexara quotes a delivered Canadian price per order, against a verified licence. Foreign list prices are published on incompatible bases and are not a guide to what any buyer can obtain here, so this page shows which markets list the molecule and on what basis, and nothing more.
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.