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Active ingredient

Fluorouracil

51 finished FDA listings contain Fluorouracil as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
FLUOROURACIL
Dosage forms
Cream, Injection, Solution, Solution
Routes
Intravenous, Topical
Manufacturers / labelers
23
Strengths listed
.04 g/g · 2 g/40g · 20 mg/ml · 25 mg/ml · 5 mg/g · 50 mg/g · 50 mg/ml
Brand names in FDA listings
Efudex, Favlyxa, Fluorouracil, Tolak

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 4492

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 016831EXTROVIS1970-07-292
ANDA 040278FRESENIUS KABI USA1998-09-303
ANDA 040279FRESENIUS KABI USA1998-09-304
NDA 020985EXTROVIS2000-10-271
ANDA 076526TARO2003-11-052
ANDA 040798ACCORD HLTHCARE2007-04-261
ANDA 040743ACCORD HLTHCARE2007-04-261
ANDA 077524DR REDDYS LABS SA2008-04-112
ANDA 090368TARO2010-03-052
ANDA 202668EUGIA PHARMA SPECLTS2012-07-172
ANDA 202669EUGIA PHARMA SPECLTS2012-07-172
NDA 022259HILL DERMACEUTICALS2015-09-181
ANDA 203609SAGENT PHARMS INC2016-02-171
ANDA 210123GLAND2017-10-277
ANDA 210124GLAND2017-12-267
ANDA 214845ACCORD HLTHCARE2021-10-071
ANDA 217295ALEMBIC2023-03-033
ANDA 217676ALEMBIC2023-10-183
ANDA 215612ENCUBE2023-11-021
ANDA 216494KINDOS2024-09-241
ANDA 215699KINDOS2025-02-061
ANDA 216942ENCUBE2025-02-121
NDA 220201AVYXA HOLDINGS2026-02-202

Official labeling on DailyMed

Showing the 12 most recent of 36 labels.

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