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.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 071500 | SUN PHARMA CANADA | 1987-06-10 | 4 |
| ANDA 072494 | TARO | 1989-01-19 | 1 |
| ANDA 072488 | TEVA | 1989-02-06 | 3 |
| ANDA 072490 | TEVA | 1989-02-07 | 1 |
| ANDA 073481 | TEVA | 1991-12-27 | 2 |
| ANDA 073085 | COSETTE PHARMS NC | 1992-02-14 | 2 |
| ANDA 072934 | FOUGERA PHARMS INC | 1995-02-27 | 2 |
| ANDA 074204 | COSETTE PHARMS NC | 1995-06-13 | 1 |
| ANDA 074799 | SUN PHARMA CANADA | 1996-12-31 | 1 |
| ANDA 074935 | SUN PHARMA CANADA | 1997-07-29 | 1 |
| ANDA 075008 | SUN PHARMA CANADA | 1999-06-30 | 2 |
| ANDA 200734 | SUN PHARMA CANADA | 2014-07-14 | 2 |
| ANDA 091282 | GLENMARK PHARMS LTD | 2014-07-14 | 1 |
| ANDA 206003 | NOVEL LABS INC | 2017-07-21 | 2 |
| ANDA 209283 | MACLEODS PHARMS | 2018-04-23 | 3 |
| ANDA 211111 | AMNEAL | 2018-06-04 | 1 |
| ANDA 209030 | PADAGIS US | 2018-06-19 | 1 |
| ANDA 208948 | ZYDUS PHARMS | 2018-07-17 | 2 |
| ANDA 210554 | AMNEAL | 2018-08-21 | 3 |
| ANDA 211410 | ENCUBE | 2018-10-16 | 1 |
| ANDA 209699 | ENCUBE ETHICALS | 2018-11-29 | 4 |
| ANDA 207554 | SCIEGEN PHARMS | 2019-03-18 | 1 |
| ANDA 212976 | XIROMED | 2019-11-26 | 5 |
| ANDA 208989 | ZYDUS LIFESCIENCES | 2020-02-10 | 6 |
| ANDA 216389 | QUAGEN | 2025-02-26 | 1 |
Official labeling on DailyMed
- FLUOCINONIDE (FLUOCINONIDE ) OINTMENT [BRYANT RANCH PREPACK] · version 104 · 2026-06-03
- FLUOCINONIDE (FLUOCINONIDE TOPICAL SOLUTION USP, 0.05%) SOLUTION [BRYANT RANCH PREPACK] · version 104 · 2026-05-20
- FLUOCINONIDE SOLUTION [SAPTALIS PHARMACEUTICALS, LLC.] · version 2 · 2026-05-13
- FLUOCINONIDE CREAM [PREFERRED PHARMACEUTICALS INC.] · version 3 · 2026-04-20
- FLUOCINONIDE OINTMENT [PREFERRED PHARMACEUTICALS INC.] · version 4 · 2026-04-20
- FLUOCINONIDE (FLUOCINONIDE TOPICAL SOLUTION USP, 0.05%) SOLUTION [BRYANT RANCH PREPACK] · version 102 · 2026-04-09
- FLUOCINONIDE CREAM [A-S MEDICATION SOLUTIONS] · version 2 · 2026-03-27
- FLUOCINONIDE SOLUTION [BRYANT RANCH PREPACK] · version 101 · 2026-03-23
- FLUOCINONIDE SOLUTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS, LLC] · version 6 · 2026-02-19
- FLUOCINONIDE CREAM [A-S MEDICATION SOLUTIONS] · version 4 · 2026-02-10
- FLUOCINONIDE (FLUOCINONIDE TOPICAL SOLUTION USP, 0.05%) SOLUTION [ENCUBE ETHICALS, INC.] · version 7 · 2026-01-12
- FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 8 · 2025-12-25
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.