Active ingredient
Bexarotene
10 finished FDA listings contain Bexarotene as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- BEXAROTENE
- Dosage forms
- Capsule, Capsule, Liquid Filled, Gel
- Routes
- Oral, Topical
- Manufacturers / labelers
- 8
- Strengths listed
- 1 g/100g · 10 mg/g · 75 mg/1
- Brand names in FDA listings
- Targretin
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 233272
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 021055 | BAUSCH | 1999-12-29 | 1 |
| NDA 021056 | BAUSCH | 2000-06-28 | 1 |
| ANDA 203174 | BIONPHARMA | 2014-08-12 | 1 |
| ANDA 209861 | ANI PHARMS | 2018-05-08 | 1 |
| ANDA 209886 | UPSHER SMITH LABS | 2018-07-25 | 1 |
| ANDA 210105 | AMNEAL PHARMS NY | 2018-09-04 | 2 |
| ANDA 209931 | TEVA PHARMS USA | 2021-01-14 | 1 |
| ANDA 215398 | AMNEAL | 2022-04-27 | 1 |
| ANDA 208628 | ASCENT PHARMS INC | 2024-09-06 | 1 |
Official labeling on DailyMed
- TARGRETIN (BEXAROTENE) CAPSULE, LIQUID FILLED [BAUSCH HEALTH US, LLC] · version 16 · 2026-07-20
- BEXAROTENE CAPSULE [AVKARE] · version 2 · 2025-11-17
- BEXAROTENE CAPSULE, LIQUID FILLED [ANI PHARMACEUTICALS, INC.] · version 8 · 2025-09-15
- BEXAROTENE CAPSULE [CAMBER PHARMACEUTICALS, INC.] · version 1 · 2025-09-10
- BEXAROTENE CAPSULE, LIQUID FILLED [ACTAVIS PHARMA, INC.] · version 8 · 2025-02-05
- BEXAROTENE GEL [AMNEAL PHARMACEUTICALS NY LLC] · version 7 · 2024-01-01
- BEXAROTENE CAPSULE [AMNEAL PHARMACEUTICALS NY LLC] · version 12 · 2023-06-08
- BEXAROTENE CAPSULE [UPSHER-SMITH LABORATORIES, INC.] · version 3 · 2023-04-17
- TARGRETIN (BEXAROTENE) GEL [BAUSCH HEALTH US, LLC] · version 11 · 2022-08-23
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.