Active ingredient
Ezetimibe
41 finished FDA listings contain Ezetimibe as their only active ingredient; 29 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- EZETIMIBE
- Dosage forms
- Tablet
- Routes
- Oral
- Manufacturers / labelers
- 24
- Strengths listed
- 10 mg/1
- Brand names in FDA listings
- Zetia
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 341248
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 021445 | ORGANON | 2002-10-25 | 1 |
| ANDA 078560 | GLENMARK PHARMS LTD | 2015-06-26 | 4 |
| ANDA 203931 | SANDOZ | 2017-06-12 | 2 |
| ANDA 204331 | ZYDUS PHARMS | 2017-06-12 | 4 |
| ANDA 208803 | AMNEAL PHARMS CO | 2017-06-12 | 3 |
| ANDA 207311 | OHM LABS INC | 2017-06-12 | 2 |
| ANDA 200831 | WATSON LABS INC | 2017-06-12 | 1 |
| ANDA 209838 | AUROBINDO PHARMA | 2017-08-25 | 8 |
| ANDA 209234 | ALKEM LABS LTD | 2017-12-21 | 7 |
| ANDA 211550 | ACCORD HLTHCARE | 2018-10-26 | 1 |
| ANDA 210673 | SCIEGEN PHARMS | 2020-10-23 | 1 |
| ANDA 210859 | HETERO LABS LTD III | 2022-07-26 | 4 |
| ANDA 215693 | ORIENT PHARMA | 2022-09-13 | 2 |
| ANDA 211159 | MACLEODS PHARMS | 2024-04-29 | 1 |
Official labeling on DailyMed
- EZETIMIBE TABLET [A-S MEDICATION SOLUTIONS] · version 3 · 2026-07-07
- EZETIMIBE TABLET [A-S MEDICATION SOLUTIONS] · version 6 · 2026-07-07
- EZETIMIBE TABLET [MAJOR PHARMACEUTICALS] · version 8 · 2026-06-08
- EZETIMIBE (EZETIMIBE) TABLET [BRYANT RANCH PREPACK] · version 1 · 2026-02-18
- EZETIMIBE TABLET [AVPAK] · version 6 · 2026-02-10
- ZETIA (EZETIMIBE) TABLET [ORGANON LLC] · version 8 · 2025-11-26
- EZETIMIBE (EZETIMIBE) TABLET [A-S MEDICATION SOLUTIONS] · version 2 · 2025-11-17
- EZETIMIBE (EZETIMIBE) TABLET [A-S MEDICATION SOLUTIONS] · version 1 · 2025-11-17
- EZETIMIBE TABLET [MARLEX PHARMACEUTICALS, INC.] · version 2 · 2025-11-17
- EZETIMIBE TABLET [GLENMARK PHARMACEUTICALS INC., USA] · version 11 · 2025-11-17
- EZETIMIBE TABLET [AMERICAN HEALTH PACKAGING] · version 7 · 2025-11-17
- EZETIMIBE TABLET [ACCORD HEALTHCARE INC.] · version 10 · 2025-11-17
Showing the 12 most recent of 40 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.