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Active ingredient

Fluocinonide

53 finished FDA listings contain Fluocinonide as their only active ingredient.

FDA NDC Directory

Ingredient names as written by FDA
FLUOCINONIDE
Dosage forms
Cream, Gel, Ointment, Solution
Routes
Topical
Manufacturers / labelers
25
Strengths listed
.05 mg/g · .5 mg/g · .5 mg/ml · 1 mg/g
Brand names in FDA listings
Fluocinonide, Fluocinonide Cream

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 4462

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 071500SUN PHARMA CANADA1987-06-104
ANDA 072494TARO1989-01-191
ANDA 072488TEVA1989-02-063
ANDA 072490TEVA1989-02-071
ANDA 073481TEVA1991-12-272
ANDA 073085COSETTE PHARMS NC1992-02-142
ANDA 072934FOUGERA PHARMS INC1995-02-272
ANDA 074204COSETTE PHARMS NC1995-06-131
ANDA 074799SUN PHARMA CANADA1996-12-311
ANDA 074935SUN PHARMA CANADA1997-07-291
ANDA 075008SUN PHARMA CANADA1999-06-302
ANDA 200734SUN PHARMA CANADA2014-07-142
ANDA 091282GLENMARK PHARMS LTD2014-07-141
ANDA 206003NOVEL LABS INC2017-07-212
ANDA 209283MACLEODS PHARMS2018-04-233
ANDA 211111AMNEAL2018-06-041
ANDA 209030PADAGIS US2018-06-191
ANDA 208948ZYDUS PHARMS2018-07-172
ANDA 210554AMNEAL2018-08-213
ANDA 211410ENCUBE2018-10-161
ANDA 209699ENCUBE ETHICALS2018-11-294
ANDA 207554SCIEGEN PHARMS2019-03-181
ANDA 212976XIROMED2019-11-265
ANDA 208989ZYDUS LIFESCIENCES2020-02-106
ANDA 216389QUAGEN2025-02-261

Official labeling on DailyMed

Showing the 12 most recent of 49 labels.

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