Medicine
Montelukast 4 mg/500 mg granules
Montelukast 4 mg/500 mg granules is a generic prescription medicine for oral use, 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 4-mg oral granules, montelukast sodium 4-mg chewable…
Key facts
- Active ingredient (INN)
- Montelukast
- Brand
- Sold under the generic name
- Strength
- 4 mg/500 mg
- Dosage form
- Granules
- Route
- Oral
- Packs
- 30 packets
- Manufacturer
- Torrent PharmaceuticalsIndia
- Origin register
- US FDA, United States
- Storage
- Store montelukast sodium 4-mg oral granules, montelukast sodium 4-mg chewable tablets, 5-mg chewable tablets and 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). Protect from moisture and light. Store in original package.
- 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
- 30 March 2017
- Identifiers
- RxCUI 200224, 242438, 311759 +1DailyMed set ID da038cf6-cfad-43a4-ab8e-d81d028d6087NDC 13668-531Application ANDA210431
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 packet in 1 carton / 500 mg in 1 packet | 13668-531-94 | Torrent PharmaceuticalsIndia | 30 March 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
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 4 mg/500 mg granules 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.