Home NDC 66530-258-30 Fluorouracil
Product NDC 66530-258
Requested package NDC 66530-258-30
11-digit product format 665300258
Labeler code 66530
Product ID 66530-258_c44712eb-0e9d-4f40-b932-e27d2a100c29
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fluorouracil
Dosage form CREAM
Route TOPICAL
Labeler Spear Dermatology Products Inc
Application NDA020985
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2014-10-28
Marketing end 2021-06-28
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 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 · 41 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 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…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020985-001 CARAC 0.5% CREAM / TOPICAL RLD, RS 2000-10-27 cb3db0bc1861…
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…
DailyMed Socrata Ingredients# 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join FLUOROURACIL FLUOROURACIL CREAM, 0.5% Dr. Reddy's Laboratories Inc. 37dcfb83-0e7d-d23d-9cd5-afa5bdc30628 2025-07-11 Warnings, Adverse reactions Exact identifier application applno (NDA): 020985 application number: NDA020985
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 66530-258-30 66530025830 30 g in 1 TUBE (66530-258-30) 30 g 2014-10-28 2021-06-28 No No Current