Home NDC 16729-542 Fluorouracil
Product NDC 16729-542
11-digit product format 167290542
Labeler code 16729
Product ID 16729-542_23a8557b-45e6-e3cf-e063-6394a90a4b0d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluorouracil
Dosage form CREAM
Route TOPICAL
Labeler Accord Healthcare Inc.
Application ANDA214845
Marketing category ANDA
Marketing start 2021-11-11
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 A214845-001 FLUOROURACIL FLUOROURACIL 5% CREAM / TOPICAL AB 2021-10-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214845-001 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.
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 A214845-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2021-10-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214845-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2021-10-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214845-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2021-10-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214845-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2021-10-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214845-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2021-10-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214845-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2021-10-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214845-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2021-10-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214845-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2021-10-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214845-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2021-10-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214845-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2021-10-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214845-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2021-10-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214845-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2021-10-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214845-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2021-10-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214845-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2021-10-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214845-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2021-10-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214845-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2021-10-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A214845-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2021-10-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A214845-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2021-10-07 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A214845-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2021-10-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A214845-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2021-10-07 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214845-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2021-10-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214845-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2021-10-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214845-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2021-10-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214845-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2021-10-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214845-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2021-10-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214845-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2021-10-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214845-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2021-10-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214845-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2021-10-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214845-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2021-10-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214845-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2021-10-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214845-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2021-10-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214845-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2021-10-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A214845-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2021-10-07 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214845-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2021-10-07 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Fluorouracil
Listing expiration 2026-12-31 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# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 16729-542-35 Fluorouracil 1 in 1 CARTON CREAM 1 5 16729-542-35 Fluorouracil 40 g in 1 TUBE CREAM 40 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16729-542 FLUOROURACIL CREAM [ACCORD HEALTHCARE INC.] 5 Current NDC, Legacy NDC, 2 package rows 20241006_667d4059-de90-4d3f-86c2-c2573def2ecb.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 16729-542-35 16729054235 1 TUBE in 1 CARTON (16729-542-35) / 40 g in 1 TUBE 1 tube 2021-11-11 0000-00-00 No No Current