Home NDC 51672-4062 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076526-001 FLUOROURACIL FLUOROURACIL 2% SOLUTION / TOPICAL AT 2003-11-05 A076526-002 FLUOROURACIL FLUOROURACIL 5% SOLUTION / TOPICAL AT RS 2003-11-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A076526-001 FLUOROURACIL 2% SOLUTION / TOPICAL AT 2003-11-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076526-002 FLUOROURACIL 5% SOLUTION / TOPICAL AT RS 2003-11-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076526-001 FLUOROURACIL 2% SOLUTION / TOPICAL AT 2003-11-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076526-002 FLUOROURACIL 5% SOLUTION / TOPICAL AT RS 2003-11-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076526-001 FLUOROURACIL 2% SOLUTION / TOPICAL AT 2003-11-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076526-002 FLUOROURACIL 5% SOLUTION / TOPICAL AT RS 2003-11-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076526-001 FLUOROURACIL 2% SOLUTION / TOPICAL AT 2003-11-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076526-002 FLUOROURACIL 5% SOLUTION / TOPICAL AT RS 2003-11-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076526-001 FLUOROURACIL 2% SOLUTION / TOPICAL AT 2003-11-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076526-002 FLUOROURACIL 5% SOLUTION / TOPICAL AT RS 2003-11-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076526-001 FLUOROURACIL 2% SOLUTION / TOPICAL AT 2003-11-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076526-002 FLUOROURACIL 5% SOLUTION / TOPICAL AT RS 2003-11-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076526-001 FLUOROURACIL 2% SOLUTION / TOPICAL AT 2003-11-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076526-002 FLUOROURACIL 5% SOLUTION / TOPICAL AT RS 2003-11-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076526-001 FLUOROURACIL 2% SOLUTION / TOPICAL AT 2003-11-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076526-002 FLUOROURACIL 5% SOLUTION / TOPICAL AT RS 2003-11-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076526-001 FLUOROURACIL 2% SOLUTION / TOPICAL AT 2003-11-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076526-002 FLUOROURACIL 5% SOLUTION / TOPICAL AT RS 2003-11-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076526-001 FLUOROURACIL 2% SOLUTION / TOPICAL AT 2003-11-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076526-002 FLUOROURACIL 5% SOLUTION / TOPICAL AT RS 2003-11-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076526-001 FLUOROURACIL 2% SOLUTION / TOPICAL AT 2003-11-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076526-002 FLUOROURACIL 5% SOLUTION / TOPICAL AT RS 2003-11-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076526-001 FLUOROURACIL 2% SOLUTION / TOPICAL AT 2003-11-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076526-002 FLUOROURACIL 5% SOLUTION / TOPICAL AT RS 2003-11-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076526-001 FLUOROURACIL 2% SOLUTION / TOPICAL AT 2003-11-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076526-002 FLUOROURACIL 5% SOLUTION / TOPICAL AT RS 2003-11-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076526-001 FLUOROURACIL 2% SOLUTION / TOPICAL AT 2003-11-05 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A076526-002 FLUOROURACIL 5% SOLUTION / TOPICAL AT RS 2003-11-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076526-001 FLUOROURACIL 2% SOLUTION / TOPICAL AT 2003-11-05 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076526-002 FLUOROURACIL 5% SOLUTION / TOPICAL RS 2003-11-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076526-001 FLUOROURACIL 2% SOLUTION / TOPICAL AT 2003-11-05 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A076526-002 FLUOROURACIL 5% SOLUTION / TOPICAL RS 2003-11-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076526-001 FLUOROURACIL 2% SOLUTION / TOPICAL AT 2003-11-05 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A076526-002 FLUOROURACIL 5% SOLUTION / TOPICAL RS 2003-11-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076526-001 FLUOROURACIL 2% SOLUTION / TOPICAL AT 2003-11-05 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A076526-002 FLUOROURACIL 5% SOLUTION / TOPICAL AT 2003-11-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076526-001 FLUOROURACIL 2% SOLUTION / TOPICAL AT 2003-11-05 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A076526-002 FLUOROURACIL 5% SOLUTION / TOPICAL RS 2003-11-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076526-001 FLUOROURACIL 2% SOLUTION / TOPICAL AT 2003-11-05 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A076526-002 FLUOROURACIL 5% SOLUTION / TOPICAL RS 2003-11-05 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 64 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Fluorouracil
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUOROURACIL 20 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U3P01618RT Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310379 Internal RxNorm lookup 310380 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# 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
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded 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
DailyMed Dashboard NDC Coverage# 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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# 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