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Active ingredient

Halobetasol

17 finished FDA listings contain Halobetasol as their only active ingredient; 1 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
HALOBETASOL PROPIONATE
Dosage forms
Aerosol, Foam, Cream, Lotion, Ointment
Routes
Topical
Manufacturers / labelers
9
Strengths listed
.1 mg/g · .5 mg/g
Brand names in FDA listings
Bryhali, Lexette, Ultravate

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 41208

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
ANDA 077123PADAGIS ISRAEL2004-12-162
ANDA 076872PADAGIS ISRAEL2004-12-164
ANDA 077109COSETTE PHARMS NC2005-06-142
ANDA 078162COSETTE PHARMS NC2007-04-241
NDA 208183LACER PHARMA2015-11-062
ANDA 209978ENCUBE2018-03-201
NDA 209355BAUSCH2018-11-061
ANDA 213560QUAGEN2020-10-062
ANDA 215266PADAGIS ISRAEL2023-08-112

Official labeling on DailyMed

Showing the 12 most recent of 17 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.