Home NDC 75907-169 FLUOROURACIL
Product NDC 75907-169
11-digit product format 759070169
Labeler code 75907
Product ID 75907-169_39a2cbc0-f588-5397-e063-6394a90a5390
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluorouracil Cream, 0.5%
Dosage form CREAM
Route TOPICAL
Labeler Dr. Reddy's Laboratories Inc.
Application NDA020985
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2025-07-06
Substance FLUOROURACIL
Active strength 5 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 N020985-001 CARAC FLUOROURACIL 0.5% CREAM / TOPICAL RLD, RS 2000-10-27
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 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020985-001 CARAC 0.5% CREAM / TOPICAL AB RLD, RS 2000-10-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020985-001 CARAC 0.5% CREAM / TOPICAL AB RLD, RS 2000-10-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020985-001 CARAC 0.5% CREAM / TOPICAL AB RLD, RS 2000-10-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020985-001 CARAC 0.5% CREAM / TOPICAL AB RLD, RS 2000-10-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020985-001 CARAC 0.5% CREAM / TOPICAL AB RLD, RS 2000-10-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020985-001 CARAC 0.5% CREAM / TOPICAL AB RLD, RS 2000-10-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 e64feba35796…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N020985-001 6670335 2021-06-02 U-68 Drug product 74a2ff9319b5…2021-12-28 21:50 UTC 2021-12 N020985-001 6670335 2021-06-02 U-68 Drug product 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020985-001 6670335 2021-06-02 U-68 Drug product 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020985-001 6670335 2021-06-02 U-68 Drug product 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020985-001 6670335 2021-06-02 U-68 Drug product 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020985-001 6670335 2021-06-02 U-68 Drug product c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020985-001 6670335 2021-06-02 U-68 Drug product 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020985-001 6670335 2021-06-02 U-68 Drug product b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020985-001 6670335 2021-06-02 U-68 Drug product ea99ee380514…
Additional Listing Data#
Finished product Yes
Brand name base FLUOROURACIL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUOROURACIL 5 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 284191 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 75907-169-11 FLUOROURACIL 30 g in 1 TUBE CREAM 30 1 75907-169-11 FLUOROURACIL 1 in 1 CARTON CREAM 1 1
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 Sample Exclude flag Status 75907-169-11 75907016911 1 TUBE in 1 CARTON (75907-169-11) / 30 g in 1 TUBE 1 tube 2025-07-06 No No Current