Active ingredient
Betamethasone
88 finished FDA listings contain Betamethasone as their only active ingredient; 32 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- BETAMETHASONE, BETAMETHASONE ACETATE, BETAMETHASONE DIPROPIONATE, BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE VALERATE
- Dosage forms
- Aerosol, Foam, Cream, Cream, Augmented, Gel, Lotion, Lotion, Augmented, Ointment, Ointment, Augmented, Spray
- Routes
- Topical
- Manufacturers / labelers
- 31
- Strengths listed
- .5 mg/g · .5 mg/ml · 1 mg/g · 1 mg/ml · 1.2 mg/g
- Brand names in FDA listings
- Betamethasone Valerate, Diprolene, Sernivo
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1514
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 018642 | COSETTE PHARMS NC | 1983-03-24 | 4 |
| NDA 018741 | ORGANON | 1983-07-27 | 2 |
| NDA 018861 | FOUGERA | 1983-08-31 | 3 |
| NDA 018865 | FOUGERA | 1983-08-31 | 2 |
| NDA 018866 | FOUGERA | 1983-08-31 | 1 |
| NDA 019137 | FOUGERA | 1984-06-26 | 3 |
| NDA 019141 | FOUGERA | 1984-09-04 | 2 |
| ANDA 070275 | FOUGERA PHARMS INC | 1985-08-12 | 1 |
| ANDA 070069 | COSETTE PHARMS NC | 1985-12-19 | 2 |
| ANDA 071012 | ACTAVIS MID ATLANTIC | 1987-02-03 | 1 |
| ANDA 070885 | ACTAVIS MID ATLANTIC | 1987-02-03 | 2 |
| ANDA 071467 | COSETTE PHARMS NC | 1987-08-10 | 1 |
| ANDA 072041 | SUN PHARMA CANADA | 1988-01-06 | 5 |
| ANDA 072538 | PADAGIS US | 1990-01-31 | 1 |
| ANDA 073552 | SUN PHARMA CANADA | 1992-04-30 | 3 |
| ANDA 074304 | ACTAVIS MID ATLANTIC | 1995-08-31 | 1 |
| ANDA 075373 | FOUGERA PHARMS | 1999-06-22 | 2 |
| ANDA 076508 | SUN PHARMA CANADA | 2003-12-02 | 1 |
| ANDA 076592 | PADAGIS ISRAEL | 2003-12-09 | 7 |
| ANDA 076543 | SUN PHARMA CANADA | 2003-12-09 | 5 |
| ANDA 077111 | FOUGERA PHARMS | 2007-05-21 | 1 |
| ANDA 077477 | SUN PHARMA CANADA | 2007-05-21 | 1 |
| ANDA 078930 | GLENMARK PHARMS | 2008-09-23 | 1 |
| ANDA 078337 | PADAGIS ISRAEL | 2012-11-26 | 1 |
| NDA 208079 | PRIMUS PHARMS | 2016-02-05 | 1 |
| ANDA 208204 | TARO | 2017-05-24 | 1 |
| ANDA 206389 | ENCUBE | 2018-02-13 | 1 |
| ANDA 210217 | COSETTE PHARMS NC | 2018-10-12 | 1 |
| ANDA 208885 | ZYDUS PHARMS | 2019-01-11 | 6 |
| ANDA 209106 | LUPIN | 2019-12-18 | 2 |
| ANDA 211722 | SUN PHARMA CANADA | 2020-06-17 | 1 |
| ANDA 214048 | ZYDUS LIFESCIENCES | 2020-07-14 | 2 |
| ANDA 215186 | TP ANDA HOLDINGS | 2022-02-18 | 1 |
| ANDA 215847 | PADAGIS ISRAEL | 2022-04-12 | 5 |
| ANDA 210639 | XIROMED | 2023-04-18 | 1 |
| ANDA 218289 | AUROBINDO PHARMA LTD | 2024-04-10 | 2 |
| ANDA 215832 | ALEMBIC | 2024-08-22 | 2 |
| ANDA 219348 | AUROBINDO PHARMA LTD | 2026-01-26 | 1 |
Official labeling on DailyMed
- BETAMETHASONE DIPROPIONATE CREAM [REMEDYREPACK INC.] · version 3 · 2026-09-02
- BETAMETHASONE DIPROPIONATE OINTMENT [ACTAVIS PHARMA, INC.] · version 13 · 2026-08-31
- BETAMETHASONE DIPROPIONATE CREAM BETAMETHASONE DIPROPIONATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS, LLC] · version 13 · 2026-08-24
- BETAMETHASONE DIPROPIONATE OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS, LLC] · version 1 · 2026-08-14
- BETAMETHASONE DIPROPIONATE CREAM [REDPHARM DRUG] · version 1 · 2026-07-22
- BETAMETHASONE DIPROPIONATE OINTMENT, AUGMENTED [A-S MEDICATION SOLUTIONS] · version 3 · 2026-05-12
- BETAMETHASONE DIPROPIONATE CREAM [AUROBINDO PHARMA LIMITED] · version 2 · 2026-05-06
- SERNIVO (BETAMETHASONE DIPROPIONATE) SPRAY [PRIMUS PHARMACEUTICALS, INC.] · version 7 · 2026-04-27
- BETAMETHASONE DIPROPIONATE OINTMENT, AUGMENTED [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS, LLC] · version 13 · 2026-04-08
- BETAMETHASONE VALERATE AEROSOL, FOAM [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 3 · 2026-03-31
- BETAMETHASONE DIPROPIONATE CREAM [PREFERRED PHARMACEUTICALS, INC.] · version 12 · 2026-03-20
- BETAMETHASONE VALERATE OINTMENT [PREFERRED PHARMACEUTICALS INC.] · version 5 · 2026-03-20
Showing the 12 most recent of 76 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.