Fluorouracil

Product NDC: 51672-4062
11-digit product format: 516724062
Labeler code: 51672
Product ID: 51672-4062_3225bf24-833e-4d6a-bfe8-08df4fecb218
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluorouracil
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Taro Pharmaceuticals U.S.A., Inc.
Application: ANDA076526
Marketing category: ANDA
Marketing start: 2003-11-05
Substance: FLUOROURACIL
Active strength: 20 mg/mL
Pharmacologic classes: Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
FLUOROURACIL	20 mg/mL

Field, Values table
Field	Values
Unii	U3P01618RT
Rxcui	310379, 310380

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75	Product name	2	20250814
7dc9482d-9b87-4471-9708-4f1b4585846b	Product name	2	20250723
a2ca0bf8-8306-49cc-93a3-3e6e4137c7cb	Product name	5	20250630
dc0d2364-4811-4665-a3ee-7ed8c7301465	Product name	2	20171219
62fb8671-1693-49d8-8aab-0c1bfdd6794e	Product name	1	20151005
878ca466-81fd-9d24-1349-31baf36065c6	Product name	2	20150506
630d1bc2-ae6b-fd31-1264-c4733e788193	Product name	1	20140508

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51672-4062-1	Fluorouracil	10 mL in 1 BOTTLE	SOLUTION	10		6
51672-4062-1	Fluorouracil	1 in 1 CARTON	SOLUTION	1		6

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-4062-1	ML - Milliliter	51672-4062	e380219d-8288-4409-81f0-89683eda27f0	1	2013-02-13

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Fluorouracil	ACTIVE INGREDIENT	U3P01618RT	FLUOROURACIL SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]	2
Fluorouracil	ACTIVE MOIETY	U3P01618RT	FLUOROURACIL SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]	2
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	FLUOROURACIL SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]	2
hydroxypropyl cellulose	INACTIVE INGREDIENT	RFW2ET671P	FLUOROURACIL SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]	2
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	FLUOROURACIL SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]	2
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	FLUOROURACIL SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]	2
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	FLUOROURACIL SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]	2
tromethamine	INACTIVE INGREDIENT	023C2WHX2V	FLUOROURACIL SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]	2
water	INACTIVE INGREDIENT	059QF0KO0R	FLUOROURACIL SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]	2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51672-4062	FLUOROURACIL SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]	6	Current NDC, Legacy NDC, 2 package rows	20221014_1b2f6145-b338-42ed-88a7-f4da65c59164.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U3P01618RT	FLUOROURACIL	51-21-8	FLUOROURACIL

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310379	fluorouracil 2 % Topical Solution	PSN	1b2f6145-b338-42ed-88a7-f4da65c59164	6
310380	fluorouracil 5 % Topical Solution	PSN	1b2f6145-b338-42ed-88a7-f4da65c59164	6
310379	fluorouracil 20 MG/ML Topical Solution	SCD	1b2f6145-b338-42ed-88a7-f4da65c59164	6
310380	fluorouracil 50 MG/ML Topical Solution	SCD	1b2f6145-b338-42ed-88a7-f4da65c59164	6
310379	5-5-fluorouracil 20 MG/ML Topical Solution	SY	1b2f6145-b338-42ed-88a7-f4da65c59164	6
310380	5-5-fluorouracil 50 MG/ML Topical Solution	SY	1b2f6145-b338-42ed-88a7-f4da65c59164	6
310379	5-FU 20 MG/ML Topical Solution	SY	1b2f6145-b338-42ed-88a7-f4da65c59164	6
310380	5-FU 50 MG/ML Topical Solution	SY	1b2f6145-b338-42ed-88a7-f4da65c59164	6
310379	fluorouracil 2 % Topical Solution	SY	1b2f6145-b338-42ed-88a7-f4da65c59164	6
310380	fluorouracil 5 % Topical Solution	SY	1b2f6145-b338-42ed-88a7-f4da65c59164	6

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51672-4062-1	51672406201	1 BOTTLE in 1 CARTON (51672-4062-1) / 10 mL in 1 BOTTLE	1 bottle	2003-11-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluorouracil Topical Solution USP, 2% and 5%	Taro Pharmaceuticals U.S.A., Inc. \| Taro Pharmaceutical Industries Ltd.	2022-09-29	HUMAN PRESCRIPTION DRUG LABEL	6