Home NDC 51672-4118 Fluorouracil
Product NDC 51672-4118
11-digit product format 516724118
Labeler code 51672
Product ID 51672-4118_170232f3-4992-1e1a-e063-6394a90a38e9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluorouracil
Dosage form CREAM
Route TOPICAL
Labeler Taro Pharmaceuticals U.S.A., Inc.
Application ANDA090368
Marketing category ANDA
Marketing start 2010-03-05
Substance FLUOROURACIL
Active strength 50 mg/g
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 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090368-001 FLUOROURACIL FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090368-001 AB
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 2 · 42 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 2026-08-18 06:07:40 2026-07 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 50 mg/g
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 105583 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Fluorouracil ACTIVE INGREDIENT U3P01618RT FLUOROURACIL CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 Fluorouracil ACTIVE MOIETY U3P01618RT FLUOROURACIL CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 methylparaben INACTIVE INGREDIENT A2I8C7HI9T FLUOROURACIL CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 petrolatum INACTIVE INGREDIENT 4T6H12BN9U FLUOROURACIL CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 polysorbate 60 INACTIVE INGREDIENT CAL22UVI4M FLUOROURACIL CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 FLUOROURACIL CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH FLUOROURACIL CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 stearyl alcohol INACTIVE INGREDIENT 2KR89I4H1Y FLUOROURACIL CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 water INACTIVE INGREDIENT 059QF0KO0R FLUOROURACIL CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-4118 FLUOROURACIL CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 10 Current NDC, Legacy NDC, 5 package rows 20240427_acca0036-f19c-459b-9dfc-9592f1cd588d.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 · 2 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 51672-4118-2 51672411802 1 TUBE in 1 CARTON (51672-4118-2) / 25 g in 1 TUBE 1 tube 2017-03-17 0000-00-00 No No Current 51672-4118-5 51672411805 5 g in 1 TUBE (51672-4118-5) 5 g 2017-03-17 0000-00-00 No No Current 51672-4118-6 51672411806 1 TUBE in 1 CARTON (51672-4118-6) / 40 g in 1 TUBE 1 tube 2017-03-17 0000-00-00 No No Current