Active ingredient
Zafirlukast
12 finished FDA listings contain Zafirlukast as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ZAFIRLUKAST
- Dosage forms
- Tablet, Coated, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 7
- Strengths listed
- 10 mg/1 · 20 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 114970
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 020547 | STRIDES PHARMA INTL | 1996-09-26 | 4 |
| ANDA 090372 | DR REDDYS LABS LTD | 2010-11-18 | 3 |
| ANDA 212475 | ANNORA PHARMA | 2020-09-10 | 3 |
| ANDA 213163 | AUROBINDO PHARMA | 2023-11-27 | 2 |
Official labeling on DailyMed
- ZAFIRLUKAST TABLET, COATED [STRIDES PHARMA SCIENCE LIMITED] · version 7 · 2026-03-17
- ZAFIRLUKAST TABLET, COATED [AVKARE] · version 3 · 2025-08-04
- ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] · version 7 · 2024-10-14
- ZAFIRLUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 100 · 2024-07-02
- ZAFIRLUKAST TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] · version 1 · 2023-12-04
- ZAFIRLUKAST TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] · version 1 · 2020-09-28
- ZAFIRLUKAST TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] · version 9 · 2019-03-12
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.