Medicine
Montelukast 5 mg chewable tablet
Montelukast 5 mg chewable tablet is a generic prescription medicine for oral use, made by 17 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 4-mg chewable tablets and 5-mg chewable tablets at 25°C…
Key facts
- Active ingredient (INN)
- Montelukast
- Brand
- Sold under the generic name
- Strength
- 5 mg
- Dosage form
- Chewable tablet
- Route
- Oral
- Packs
- 30 tablets, 90 tablets, 500 tablets and 56 more
- Manufacturers
- Camber PharmaceuticalsIndiaMacleods PharmaceuticalsIndiaDr. Reddy's LaboratoriesIndiaAurobindo PharmaIndiaTorrent PharmaceuticalsIndiaUnichem LaboratoriesIndiaAjanta PharmaIndiaProficient RxLannettRising Pharma Holdings17 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store montelukast 4-mg chewable tablets and 5-mg chewable tablets at 25°C (77°F), excursions permitted to 15-30°C (59-86°F). Storage for Bulk Bottles Store bottles of 1000 montelukast 4-mg chewable tablets and 5-mg chewable tablets at 25°C (77°F), excursions permitted to 15-30°C (59-86°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
- 3 August 2012
- Identifiers
- RxCUI 242438, 311759, 200224 +1DailyMed set ID 5cb4298c-10b1-4d6f-95ad-4aad72daf249, ed2caffa-a75c-1c27-ae30-2d8280eaea7d, 2f90a573-27fd-cc16-f3d1-8c4d630224a0 +17NDC 62135-782, 42291-623, 50268-574 +17Application ANDA200405, ANDA090984, ANDA204093 +7
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 17 labelers. The register lists 59 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 tablet, chewable in 1 bottle | 27241-017-03 | Ajanta PharmaIndia | 13 August 2015 |
| 90 tablet, chewable in 1 bottle | 27241-017-09 | Ajanta PharmaIndia | 13 August 2015 |
| 500 tablet, chewable in 1 bottle | 65862-568-05 | Aurobindo PharmaIndia | 3 August 2012 |
| 30 tablet, chewable in 1 bottle | 65862-568-30 | Aurobindo PharmaIndia | 3 August 2012 |
| 90 tablet, chewable in 1 bottle | 65862-568-90 | Aurobindo PharmaIndia | 3 August 2012 |
| 100 tablet, chewable in 1 bottle | 31722-728-01 | Camber PharmaceuticalsIndia | 27 May 2015 |
| 1000 tablet, chewable in 1 bottle | 31722-728-10 | Camber PharmaceuticalsIndia | 27 May 2015 |
| 30 tablet, chewable in 1 bottle | 31722-728-30 | Camber PharmaceuticalsIndia | 27 May 2015 |
| 10 tablet, chewable in 1 blister pack | 31722-728-31 | Camber PharmaceuticalsIndia | 27 May 2015 |
| 100 tablet, chewable in 1 carton | 31722-728-32 | Camber PharmaceuticalsIndia | 27 May 2015 |
| 90 tablet, chewable in 1 bottle | 31722-728-90 | Camber PharmaceuticalsIndia | 27 May 2015 |
| 500 tablet, chewable in 1 bottle | 55111-594-05 | Dr. Reddy's LaboratoriesIndia | 6 August 2012 |
| 30 tablet, chewable in 1 bottle | 55111-594-30 | Dr. Reddy's LaboratoriesIndia | 6 August 2012 |
| 10 blister pack in 1 carton / 10 tablet, chewable in 1 blister pack | 55111-594-78 | Dr. Reddy's LaboratoriesIndia | 6 August 2012 |
| 90 tablet, chewable in 1 bottle | 55111-594-90 | Dr. Reddy's LaboratoriesIndia | 6 August 2012 |
| 30 tablet, chewable in 1 bottle | 33342-111-07 | Macleods PharmaceuticalsIndia | 13 March 2015 |
| 90 tablet, chewable in 1 bottle | 33342-111-10 | Macleods PharmaceuticalsIndia | 13 March 2015 |
| 100 tablet, chewable in 1 blister pack | 33342-111-12 | Macleods PharmaceuticalsIndia | 13 March 2015 |
| 500 tablet, chewable in 1 bottle | 33342-111-15 | Macleods PharmaceuticalsIndia | 13 March 2015 |
| 90 tablet, chewable in 1 blister pack | 33342-111-39 | Macleods PharmaceuticalsIndia | 13 March 2015 |
| 1000 tablet, chewable in 1 bottle | 33342-111-44 | Macleods PharmaceuticalsIndia | 25 September 2015 |
| 500 tablet, chewable in 1 bottle | 13668-080-05 | Torrent PharmaceuticalsIndia | 3 August 2012 |
| 30 tablet, chewable in 1 bottle | 13668-080-30 | Torrent PharmaceuticalsIndia | 3 August 2012 |
| 90 tablet, chewable in 1 bottle | 13668-080-90 | Torrent PharmaceuticalsIndia | 3 August 2012 |
| 1000 tablet, chewable in 1 bottle, plastic | 29300-222-10 | Unichem LaboratoriesIndia | 20 August 2018 |
| 30 tablet, chewable in 1 bottle, plastic | 29300-222-13 | Unichem LaboratoriesIndia | 20 August 2018 |
| 90 tablet, chewable in 1 bottle, plastic | 29300-222-19 | Unichem LaboratoriesIndia | 20 August 2018 |
| 30 tablet, chewable in 1 bottle | 65162-772-03 | Amneal Pharmaceuticals | 4 September 2020 |
| 30 tablet, chewable in 1 bottle | 62135-782-30 | Chartwell RX | 6 October 2023 |
| 30 tablet, chewable in 1 bottle | 62175-205-32 | Lannett | 3 August 2012 |
| 1000 tablet, chewable in 1 bottle | 62175-205-43 | Lannett | 3 August 2012 |
| 90 tablet, chewable in 1 bottle | 62175-205-46 | Lannett | 3 August 2012 |
| 30 tablet, chewable in 1 bottle | 57237-213-30 | Rising Pharma Holdings | 3 August 2012 |
| 90 tablet, chewable in 1 bottle | 57237-213-90 | Rising Pharma Holdings | 3 August 2012 |
| 30 tablet, chewable in 1 bottle | 63187-626-30 | Proficient Rx | 1 December 2018 |
| 60 tablet, chewable in 1 bottle | 63187-626-60 | Proficient Rx | 1 December 2018 |
| 90 tablet, chewable in 1 bottle | 63187-626-90 | Proficient Rx | 1 December 2018 |
| 30 tablet, chewable in 1 bottle | 63187-896-30 | Proficient Rx | 1 August 2017 |
| 60 tablet, chewable in 1 bottle | 63187-896-60 | Proficient Rx | 1 August 2017 |
| 90 tablet, chewable in 1 bottle | 63187-896-90 | Proficient Rx | 1 August 2017 |
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 5 mg chewable 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 5 mg chewable tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.