Medicine
Zafirlukast 20 mg tablet
Zafirlukast 20 mg tablet is a generic prescription medicine for oral use, made by 7 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 at controlled room temperature, 20 to 25°C (68 to 77°F). Protect from…
Key facts
- Active ingredient (INN)
- Zafirlukast
- Brand
- Sold under the generic name
- Strength
- 20 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 60 tablets, 10 blister pack, 500 tablets and 10 more
- Manufacturers
- Dr. Reddy's LaboratoriesIndiaCamber PharmaceuticalsIndiaAurobindo PharmaIndiaStrides PharmaIndiaAmerican Health PackagingAvKAREBryant Ranch Prepack
- Origin register
- US FDA, United States
- Storage
- Store at controlled room temperature, 20 to 25°C (68 to 77°F). Protect from light and moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- R03DC01 Zafirlukast
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 18 November 2010
- Identifiers
- RxCUI 199655, 313758DailyMed set ID f89a821d-396f-a3aa-e053-6294a90a4577, 5d30ffab-38a1-411d-94ad-0a15c227d882, a60f39f6-d590-4b00-8751-7f12b7ec5385 +4NDC 42291-971, 31722-008, 68084-059 +4Application NDA020547, ANDA212475, ANDA090372 +1
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 60 tablet, film coated in 1 bottle | 59651-292-60 | Aurobindo PharmaIndia | 27 November 2023 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 31722-008-01 | Camber PharmaceuticalsIndia | 10 September 2020 |
| 500 tablet, film coated in 1 bottle | 31722-008-05 | Camber PharmaceuticalsIndia | 10 September 2020 |
| 60 tablet, film coated in 1 bottle | 31722-008-60 | Camber PharmaceuticalsIndia | 10 September 2020 |
| 100 tablet, film coated in 1 bottle | 55111-626-01 | Dr. Reddy's LaboratoriesIndia | 18 November 2010 |
| 500 tablet, film coated in 1 bottle | 55111-626-05 | Dr. Reddy's LaboratoriesIndia | 18 November 2010 |
| 30 tablet, film coated in 1 bottle | 55111-626-30 | Dr. Reddy's LaboratoriesIndia | 18 November 2010 |
| 60 tablet, film coated in 1 bottle | 55111-626-60 | Dr. Reddy's LaboratoriesIndia | 18 November 2010 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 55111-626-78 | Dr. Reddy's LaboratoriesIndia | 18 November 2010 |
| 60 tablet, coated in 1 bottle | 64380-188-01 | Strides PharmaIndia | 1 August 2022 |
| 30 blister pack in 1 box, unit-dose / 1 tablet, film coated in 1 blister pack | 68084-059-21 | American Health Packaging | 3 June 2013 |
| 60 tablet, coated in 1 bottle | 42291-971-60 | AvKARE | 5 April 2023 |
| 60 tablet, film coated in 1 bottle | 72162-2361-6 | Bryant Ranch Prepack | 28 June 2024 |
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 26 September 1996 | 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 Zafirlukast
Clinical summary
Zafirlukast is a leukotriene receptor antagonist indicated for the prophylaxis and chronic treatment of asthma in adults and children 5 years of age and older. It is available as tablets for oral use. MedsAcross supplies Zafirlukast 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 ZafirlukastFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Zafirlukast prescribing information (Strides Pharma) · U.S. National Library of Medicine, DailyMed
Need Zafirlukast 20 mg 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.