Active ingredient
Montelukast
93 finished FDA listings contain Montelukast as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- MONTELUKAST, MONTELUKAST SODIUM
- Dosage forms
- Granule, Tablet, Tablet, Chewable, Tablet, Coated, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 37
- Strengths listed
- 10 mg/1 · 4 mg/1 · 4 mg/500mg · 5 mg/1
- Brand names in FDA listings
- Montelukast, Montelukast Sodium, Singulair
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 88249
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 020830 | ORGANON | 1998-02-20 | 2 |
| NDA 020829 | ORGANON | 1998-02-20 | 1 |
| NDA 021409 | ORGANON | 2002-07-26 | 1 |
| ANDA 202096 | AUROBINDO PHARMA LTD | 2012-08-03 | 4 |
| ANDA 200405 | LANNETT CO INC | 2012-08-03 | 10 |
| ANDA 200889 | AIPING PHARM INC | 2012-08-03 | 1 |
| ANDA 202468 | AUROBINDO PHARMA LTD | 2012-08-03 | 4 |
| ANDA 090984 | TORRENT PHARMS LTD | 2012-08-03 | 4 |
| ANDA 201515 | TORRENT PHARMS LTD | 2012-08-03 | 3 |
| ANDA 201582 | DR REDDYS LABS LTD | 2012-08-06 | 2 |
| ANDA 201581 | SENORES PHARMS | 2012-08-06 | 2 |
| ANDA 202717 | ACCORD HLTHCARE | 2012-09-21 | 7 |
| ANDA 202843 | HETERO LABS LTD V | 2014-09-10 | 13 |
| ANDA 203366 | MACLEODS PHARMS | 2014-09-11 | 5 |
| ANDA 203037 | PHARMOBEDIENT | 2014-10-30 | 1 |
| ANDA 203582 | MACLEODS PHARMS | 2015-03-12 | 2 |
| ANDA 204093 | HETERO LABS LTD V | 2015-05-22 | 9 |
| ANDA 203432 | AJANTA PHARMA LTD | 2015-07-31 | 2 |
| ANDA 203328 | AJANTA PHARMA LTD | 2015-07-31 | 4 |
| ANDA 203438 | AJANTA PHARMA LTD | 2015-07-31 | 1 |
| ANDA 204604 | AMNEAL PHARMS | 2015-09-04 | 1 |
| ANDA 204290 | UNICHEM | 2015-10-08 | 5 |
| ANDA 205683 | ANBISON LAB | 2016-01-12 | 1 |
| ANDA 209012 | RISING | 2017-04-24 | 2 |
| ANDA 208621 | UNICHEM | 2018-07-02 | 2 |
| ANDA 210431 | TORRENT | 2018-07-31 | 1 |
| ANDA 213471 | AUROBINDO PHARMA LTD | 2020-02-18 | 1 |
| ANDA 205107 | AMNEAL PHARMS | 2020-09-04 | 2 |
Official labeling on DailyMed
- MONTELUKAST TABLET [COUPLER LLC] · version 1 · 2026-08-06
- MONTELUKAST SODIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] · version 3 · 2026-07-30
- MONTELUKAST TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] · version 7 · 2026-07-30
- MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET MONTELUKAST SODIUM GRANULE [TORRENT PHARMACEUTICALS LIMITED] · version 24 · 2026-07-30
- MONTELUKAST SODIUM TABLET [PREFERRED PHARMACEUTICALS INC.] · version 3 · 2026-07-30
- MONTELUKAST (MONTELUKAST SODIUM) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] · version 4 · 2026-07-06
- MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.] · version 11 · 2026-07-01
- MONTELUKAST SODIUM GRANULE MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST) TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AJANTA PHARMA USA INC.] · version 20 · 2026-05-11
- MONTELUKAST TABLET, FILM COATED [REMEDYREPACK INC.] · version 9 · 2026-04-06
- MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE [A-S MEDICATION SOLUTIONS] · version 1 · 2026-03-16
- MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE [A-S MEDICATION SOLUTIONS] · version 10 · 2026-03-09
- MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE [A-S MEDICATION SOLUTIONS] · version 1 · 2026-03-06
Showing the 12 most recent of 64 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.