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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.

ApplicationSponsorOriginal approvalListings
NDA 018642COSETTE PHARMS NC1983-03-244
NDA 018741ORGANON1983-07-272
NDA 018861FOUGERA1983-08-313
NDA 018865FOUGERA1983-08-312
NDA 018866FOUGERA1983-08-311
NDA 019137FOUGERA1984-06-263
NDA 019141FOUGERA1984-09-042
ANDA 070275FOUGERA PHARMS INC1985-08-121
ANDA 070069COSETTE PHARMS NC1985-12-192
ANDA 071012ACTAVIS MID ATLANTIC1987-02-031
ANDA 070885ACTAVIS MID ATLANTIC1987-02-032
ANDA 071467COSETTE PHARMS NC1987-08-101
ANDA 072041SUN PHARMA CANADA1988-01-065
ANDA 072538PADAGIS US1990-01-311
ANDA 073552SUN PHARMA CANADA1992-04-303
ANDA 074304ACTAVIS MID ATLANTIC1995-08-311
ANDA 075373FOUGERA PHARMS1999-06-222
ANDA 076508SUN PHARMA CANADA2003-12-021
ANDA 076592PADAGIS ISRAEL2003-12-097
ANDA 076543SUN PHARMA CANADA2003-12-095
ANDA 077111FOUGERA PHARMS2007-05-211
ANDA 077477SUN PHARMA CANADA2007-05-211
ANDA 078930GLENMARK PHARMS2008-09-231
ANDA 078337PADAGIS ISRAEL2012-11-261
NDA 208079PRIMUS PHARMS2016-02-051
ANDA 208204TARO2017-05-241
ANDA 206389ENCUBE2018-02-131
ANDA 210217COSETTE PHARMS NC2018-10-121
ANDA 208885ZYDUS PHARMS2019-01-116
ANDA 209106LUPIN2019-12-182
ANDA 211722SUN PHARMA CANADA2020-06-171
ANDA 214048ZYDUS LIFESCIENCES2020-07-142
ANDA 215186TP ANDA HOLDINGS2022-02-181
ANDA 215847PADAGIS ISRAEL2022-04-125
ANDA 210639XIROMED2023-04-181
ANDA 218289AUROBINDO PHARMA LTD2024-04-102
ANDA 215832ALEMBIC2024-08-222
ANDA 219348AUROBINDO PHARMA LTD2026-01-261

Official labeling on DailyMed

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.