Home NDC 75907-095 FLUOROURACIL
Product NDC 75907-095
11-digit product format 759070095
Labeler code 75907
Product ID 75907-095_984dd0bc-f7a7-b4a9-6d64-0b45a161d9d3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FLUOROURACIL
Dosage form CREAM
Route TOPICAL
Labeler Dr. Reddy's Labratories Inc.
Application ANDA077524
Marketing category ANDA
Marketing start 2024-04-15
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 A077524-001 FLUOROURACIL FLUOROURACIL 5% CREAM / TOPICAL AB 2008-04-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077524-001 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 A077524-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2008-04-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077524-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2008-04-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077524-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2008-04-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077524-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2008-04-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077524-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2008-04-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077524-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2008-04-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077524-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2008-04-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077524-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2008-04-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077524-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2008-04-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077524-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2008-04-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077524-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2008-04-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077524-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2008-04-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077524-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2008-04-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077524-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2008-04-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077524-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2008-04-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077524-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2008-04-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077524-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2008-04-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077524-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2008-04-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077524-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2008-04-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077524-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2008-04-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077524-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2008-04-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077524-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2008-04-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077524-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2008-04-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077524-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2008-04-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077524-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2008-04-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077524-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2008-04-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077524-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2008-04-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077524-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2008-04-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077524-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2008-04-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077524-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2008-04-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077524-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2008-04-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077524-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2008-04-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077524-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2008-04-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077524-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2008-04-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077524-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2008-04-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077524-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2008-04-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077524-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2008-04-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077524-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2008-04-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077524-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2008-04-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077524-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2008-04-11 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 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 75907-095-40 FLUOROURACIL 1 in 1 CARTON CREAM 1 1 75907-095-40 FLUOROURACIL 40 g in 1 TUBE CREAM 40 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 75907-095 FLUOROURACIL CREAM [DR. REDDY'S LABRATORIES INC.] 1 Current NDC, 2 package rows 20240415_e137c766-1f7f-0251-90b9-450c3d4d78b9.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 Sample Exclude flag Status 75907-095-40 75907009540 1 TUBE in 1 CARTON (75907-095-40) / 40 g in 1 TUBE 1 tube 2024-04-15 No No Current