Fluorouracil

Treats multiple actinic or solar keratoses. Sold as Fluorouracil, Fluoroplex, Efudex, Adrucil, Carac and 2 more. Every FDA application for this active ingredient: 8 branded and 44 generic.

As of Nov 14, 2026, FDA lists 52 applications for Fluorouracil (sold as Fluorouracil, Fluoroplex, Efudex and others), first approved Apr 25, 1962, with 1 new use approved and 0 published complete response letters.

First approved: Apr 25, 1962
Applications: 52
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $52.6M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Fluorouracil	Part D	$50.3M	+10%	696,245
Adrucil	Part B	$2.2M	-35%	34,129
Efudex	Part D	$1K	-97%	23
Tolak	Part D	$0K	-100%	0

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

FLUOROURACIL 0.5% CREAM: $42.82 per GMGeneric · new this year
FLUOROURACIL 2% TOPICAL SOLN: $3.38 per MLGeneric · -23% in a year
FLUOROURACIL 5% CREAM: $0.647 per GMGeneric · +2% in a year
FLUOROURACIL 5% TOPICAL SOLN: $4.29 per MLGeneric · -3% in a year

Orphan Designations (FDA)

4 designations, 0 approved for the designated use; see all orphan designations

Treatment of glioblastoma multiforme.Ethypharm SA · designated Jun 29, 2000
For use in combination with interferon alpha-2a, recombinant, for the treatment of advanced colorectal carcinoma.Hoffmann-La Roche, Inc. · designated Apr 18, 1990 · withdrawn
For use in combination with interferon alpha-2a, recombinant, for the treatment of esophageal carcinoma.Hoffmann-La Roche, Inc. · designated Oct 27, 1989 · withdrawn
For use in combination with leucovorin for therapy of metastatic adenocarcinoma of the colon and rectum.Lederle Laboratories · designated Feb 6, 1989

Approvals in Japan (PMDA)

PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

5-FUDrugs with a new indication and a new dosage for the treatment of unresectable advanced or recurrent gastric cancer. · Kyowa Kirin Co., Ltd. · Mar 26, 2024
5-FUDrugs with a new indication and a new dosage for the treatment of unresectable advanced or recurrent gastric cancer. · Kyowa Kirin Co., Ltd. · Mar 27, 2023
5-FUDrugs with a new indication and a new dosage for the treatment of esophageal cancer. · Kyowa Kirin Co., Ltd. · Nov 25, 2021
5-FUDrugs with a new indication and a new dosage for the treatment of small intestine cancer. · Kyowa Hakko Kirin Co., Ltd. · Sep 21, 2018

Clinical Trials

1,279 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


RC118 Combined With RC148 as First-Line Treatment for Claudin 18.2-Positive, HER2-Negative Advanced G/GEJ AdenocarcinomaAdvanced Gastric or Gastroesophageal Junction Adenocarcinoma · RemeGen Co., Ltd.	Phase 2 / Phase 3	Not yet recruiting	Nov 13, 2026
SCRT Combined With CAPOX and PD-1 Antibody Versus LCRT Combined With CAPOX for Early Low-lying Rectal Cancer (TORCH-E3)Early Low Rectal Cancer · Fudan University	Phase 3	Not yet recruiting	Nov 12, 2026
QL1706 and Lenvatinib Combined With FOLFOX Systemic Chemotherapy as Second-line Treatment in Advanced Hepatocellular Carcinoma PatientsHepatocellular Carcinoma (HCC) · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Phase 2	Not yet recruiting	Nov 12, 2026
Predicting Benefit From Anthracycline-Free Adjuvant Chemotherapy in High-Risk HER2-Negative Breast CancerBreast Neoplasms, HER2-negative Breast Cancer · Peking Union Medical College Hospital	—	Active, not recruiting	Nov 9, 2026
Hepatic Arterial Infusion Chemotherapy Versus Capecitabine as Adjuvant Therapy for Resected Biliary Tract CancerBiliary Tract Cancer, Cholangiocarcinoma · Zhai Wenlong	Phase 3	Not yet recruiting	Nov 4, 2026
Sintilimab Combined With LCCRT Followed by Capeox Chemotherapy in pMMR/MSS/MSI-L Locally Advanced Rectal CancerLocally Advanced Rectal Cancer · Innovent Biologics (Suzhou) Co. Ltd.	Phase 3	Not yet recruiting	Nov 4, 2026
A Phase Ib/II Study of GFH276 in Combination With Chemotherapy (± Bevacizumab) or Cetuximab in Patients With RAS-mutant Metastatic Colorectal CancerCRC · Genfleet Therapeutics (Shanghai) Inc.	Phase 1 / Phase 2	Not yet recruiting	Nov 4, 2026
Feasibility Study of Huangqi Yangyuan Formula for Capecitabine-Induced Adverse Reactions in Advanced Colorectal CancerAdvanced Colorectal Cancer, Capecitabine-Related Adverse Reaction · Huanfang Fan	Not applicable	Not yet recruiting	Nov 3, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Apr 25, 1962	FluorouracilNDA 12209 · New molecular entity	Spectrum Pharms	28	Discontinued
Jul 29, 1970	EfudexNDA 16831 · New dosage form	Extrovis	45	Marketed
Jul 31, 1970	FluoroplexNDA 16765 · New dosage form	Elorac	17	Discontinued
Aug 6, 1971	FluoroplexNDA 16988 · New formulation or manufacturer	Chartwell Rx	20	Discontinued
Oct 13, 1982	FluorouracilANDA 87792	Spectrum Pharms	3	Discontinued
Jan 18, 1983	FluorouracilANDA 87791	Marchar	0	Discontinued
Jan 26, 1988	FluorouracilANDA 89508	Bedford	3	Discontinued
Aug 28, 1991	AdrucilANDA 81225	Teva Parenteral	5	Discontinued
Oct 18, 1991	AdrucilANDA 40023	Teva Parenteral	4	Discontinued
Sep 30, 1998	FluorouracilANDA 40278	Fresenius Kabi USA	5	Marketed
Sep 30, 1998	FluorouracilANDA 40279	Fresenius Kabi USA	5	Marketed
Mar 24, 1999	FluorouracilANDA 40291	Fresenius Kabi USA	1	Discontinued
Jan 27, 2000	FluorouracilANDA 40333	Teva Pharms USA	3	Discontinued
Feb 25, 2000	FluorouracilANDA 40334	Teva Pharms USA	3	Discontinued
Oct 27, 2000	CaracNDA 20985 · New dosage form	Extrovis	8	Marketed
Nov 15, 2000	FluorouracilANDA 40379	Fresenius Kabi USA	0	Discontinued
Nov 5, 2003	FluorouracilANDA 76526	Taro	1	Marketed
Apr 26, 2007	FluorouracilANDA 40743	Accord Hlthcare	3	Marketed
Apr 26, 2007	FluorouracilANDA 40798	Accord Hlthcare	3	Marketed
Apr 11, 2008	FluorouracilANDA 77524	Dr Reddys Labs SA	2	Marketed
Aug 11, 2008	FluorouracilANDA 40772	Ebewe Pharma	0	Discontinued
Mar 5, 2010	FluorouracilANDA 90368	Taro	2	Marketed
May 2, 2011	FluorouracilANDA 91299	Sandoz	0	Discontinued
Jul 17, 2012	FluorouracilANDA 202668	Eugia Pharma Speclts	3	Marketed
Jul 17, 2012	FluorouracilANDA 202669	Eugia Pharma Speclts	3	Marketed
Apr 20, 2015	FluorouracilANDA 203122	Extrovis	1	Discontinued
Sep 18, 2015	TolakNDA 22259 · New formulation or manufacturer	Hill Dermaceuticals	1	Marketed
Feb 17, 2016	FluorouracilANDA 203609	Sagent Pharms Inc	3	Marketed
May 11, 2017	FluorouracilANDA 203608	Sagent Pharms Inc	2	Marketed
Oct 27, 2017	FluorouracilANDA 210123	Gland	2	Marketed
Dec 26, 2017	FluorouracilANDA 210124	Gland	2	Marketed
Dec 11, 2019	FluorouracilANDA 209271	Ingenus Pharms LLC	2	Discontinued
Dec 12, 2019	FluorouracilANDA 209219	Ingenus Pharms LLC	2	Discontinued
Oct 7, 2021	FluorouracilANDA 214845	Accord Hlthcare	1	Marketed
Mar 3, 2023	FluorouracilANDA 217295	Alembic	2	Marketed
Oct 18, 2023	FluorouracilANDA 217676	Alembic	2	Marketed
Nov 2, 2023	FluorouracilANDA 215612	Encube	0	Marketed
Sep 24, 2024	FluorouracilANDA 216494	Kindos	1	Marketed
Feb 6, 2025	FluorouracilANDA 215699	Kindos	1	Marketed
Feb 12, 2025	FluorouracilANDA 216942	Encube	0	Marketed
Feb 20, 2026	FavlyxaNDA 220201 · New formulation or manufacturer	Avyxa Holdings	0	Marketed
—	AdrucilNDA 17959	Pharmacia And Upjohn	0	Discontinued
—	AdrucilANDA 81222	Pharmacia And Upjohn	0	Discontinued
—	FluorouracilANDA 88766	Smith And Nephew	0	Discontinued
—	FluorouracilANDA 88767	Smith And Nephew	0	Discontinued
—	FluorouracilANDA 88929	Abic	0	Discontinued
—	FluorouracilANDA 89152	Abraxis Pharm	0	Discontinued
—	FluorouracilANDA 89368	Quad Pharms	0	Discontinued
—	FluorouracilANDA 89428	Abraxis Pharm	0	Discontinued
—	FluorouracilANDA 89434	Smith And Nephew	0	Discontinued
—	FluorouracilANDA 89455	Quad Pharms	0	Discontinued
—	FluorouracilANDA 89519	Abraxis Pharm	0	Discontinued

Show all 52

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA