Medicine
Montelukast 10 mg tablet
Montelukast 10 mg tablet is a generic prescription medicine for oral use, made by 30 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store montelukast sodium 10-mg film-coated tablets at 20° to 25°C (68° to…
Key facts
- Active ingredient (INN)
- Montelukast
- Brand
- Sold under the generic name
- Strength
- 10 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets, 90 tablets, 1000 tablets and 124 more
- Manufacturers
- Aurobindo PharmaIndiaCamber PharmaceuticalsIndiaDr. Reddy's LaboratoriesIndiaMacleods PharmaceuticalsIndiaTorrent PharmaceuticalsIndiaUnichem LaboratoriesIndiaAccord HealthcareIndiaAjanta PharmaIndiaRising Pharma HoldingsAmneal Pharmaceuticals30 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store montelukast sodium 10-mg film-coated tablets at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). Storage for Bulk Bottles Store bottles of 500 montelukast sodium 10-mg filmcoated tablets at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). Protect from moisture and light. Store in original package. Store in original container.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- R03DC03 Montelukast
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 28 February 2012
- Identifiers
- RxCUI 200224, 242438, 311759 +1DailyMed set ID 4c411d3e-47b6-481b-b846-419ed4cbb947, 3d4451a9-d73d-b9de-68ec-853bfeff6e4b, 901385e5-7384-4c28-a36a-7dd84c36f5fd +37NDC 68001-361, 55111-725, 63187-692 +37Application ANDA203366, ANDA201582, ANDA203432 +9
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
A sample of 40 packs from 30 labelers. The register lists 127 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 tablet, film coated in 1 bottle | 16729-119-10 | Accord HealthcareIndia | 11 June 2013 |
| 90 tablet, film coated in 1 bottle | 16729-119-15 | Accord HealthcareIndia | 11 April 2013 |
| 1000 tablet, film coated in 1 bottle | 16729-119-17 | Accord HealthcareIndia | 20 November 2014 |
| 30 tablet, coated in 1 bottle | 27241-018-03 | Ajanta PharmaIndia | 13 August 2015 |
| 90 tablet, coated in 1 bottle | 27241-018-09 | Ajanta PharmaIndia | 13 August 2015 |
| 1000 tablet, coated in 1 bottle | 27241-018-90 | Ajanta PharmaIndia | 13 August 2015 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 65862-574-10 | Aurobindo PharmaIndia | 3 August 2012 |
| 10000 tablet, film coated in 1 bottle | 65862-574-19 | Aurobindo PharmaIndia | 3 August 2012 |
| 30 tablet, film coated in 1 bottle | 65862-574-30 | Aurobindo PharmaIndia | 3 August 2012 |
| 6000 tablet, film coated in 1 bottle | 65862-574-66 | Aurobindo PharmaIndia | 31 August 2026 |
| 90 tablet, film coated in 1 bottle | 65862-574-90 | Aurobindo PharmaIndia | 3 August 2012 |
| 100 tablet, film coated in 1 bottle | 31722-726-01 | Camber PharmaceuticalsIndia | 10 September 2014 |
| 1000 tablet, film coated in 1 bottle | 31722-726-10 | Camber PharmaceuticalsIndia | 10 September 2014 |
| 30 tablet, film coated in 1 bottle | 31722-726-30 | Camber PharmaceuticalsIndia | 10 September 2014 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 31722-726-32 | Camber PharmaceuticalsIndia | 10 September 2014 |
| 90 tablet, film coated in 1 bottle | 31722-726-90 | Camber PharmaceuticalsIndia | 10 September 2014 |
| 100 tablet, coated in 1 bottle | 55111-725-01 | Dr. Reddy's LaboratoriesIndia | 6 August 2012 |
| 1000 tablet, coated in 1 bottle | 55111-725-10 | Dr. Reddy's LaboratoriesIndia | 6 August 2012 |
| 30 tablet, coated in 1 bottle | 55111-725-30 | Dr. Reddy's LaboratoriesIndia | 6 August 2012 |
| 10 blister pack in 1 carton / 10 tablet, coated in 1 blister pack | 55111-725-78 | Dr. Reddy's LaboratoriesIndia | 6 August 2012 |
| 90 tablet, coated in 1 bottle | 55111-725-90 | Dr. Reddy's LaboratoriesIndia | 6 August 2012 |
| 30 tablet in 1 bottle | 33342-102-07 | Macleods PharmaceuticalsIndia | 11 September 2014 |
| 90 tablet in 1 bottle | 33342-102-10 | Macleods PharmaceuticalsIndia | 11 September 2014 |
| 100 tablet in 1 blister pack | 33342-102-12 | Macleods PharmaceuticalsIndia | 11 September 2014 |
| 500 tablet in 1 bottle | 33342-102-15 | Macleods PharmaceuticalsIndia | 11 September 2014 |
| 90 tablet in 1 blister pack | 33342-102-39 | Macleods PharmaceuticalsIndia | 11 September 2014 |
| 500 tablet in 1 bottle | 13668-081-05 | Torrent PharmaceuticalsIndia | 3 August 2012 |
| 30 tablet in 1 bottle | 13668-081-30 | Torrent PharmaceuticalsIndia | 3 August 2012 |
| 3200 tablet in 1 bottle | 13668-081-32 | Torrent PharmaceuticalsIndia | 3 August 2012 |
| 100 tablet in 1 carton | 13668-081-74 | Torrent PharmaceuticalsIndia | 3 August 2012 |
| 90 tablet in 1 bottle | 13668-081-90 | Torrent PharmaceuticalsIndia | 3 August 2012 |
| 100 tablet, film coated in 1 bottle, plastic | 29300-220-01 | Unichem LaboratoriesIndia | 1 January 2016 |
| 1000 tablet, film coated in 1 bottle, plastic | 29300-220-10 | Unichem LaboratoriesIndia | 1 January 2016 |
| 30 tablet, film coated in 1 bottle, plastic | 29300-220-13 | Unichem LaboratoriesIndia | 1 January 2016 |
| 90 tablet, film coated in 1 bottle, plastic | 29300-220-19 | Unichem LaboratoriesIndia | 1 January 2016 |
| 90 tablet in 1 bottle | 16571-100-09 | Rising Pharma Holdings | 1 June 2023 |
| 1000 tablet in 1 bottle | 16571-100-10 | Rising Pharma Holdings | 1 June 2023 |
| 30 tablet, film coated in 1 bottle | 57237-255-30 | Rising Pharma Holdings | 3 August 2012 |
| 90 tablet, film coated in 1 bottle | 57237-255-90 | Rising Pharma Holdings | 3 August 2012 |
| 30 tablet in 1 bottle | 65162-732-03 | Amneal Pharmaceuticals | 31 July 2013 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 20 February 1998 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Montelukast 10 mg tablet.
Other strengths and forms of Montelukast
Clinical summary
Montelukast is a leukotriene receptor antagonist indicated for prophylaxis and chronic treatment of asthma in patients 12 months of age and older, among other approved uses. MedsAcross supplies Montelukast for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about MontelukastFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- SINGULAIR prescribing information (Organon) · U.S. National Library of Medicine, DailyMed
Need Montelukast 10 mg tablet for your hospital or patient?
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