Home NDC 66530-249-40 FLUOROURACIL
Product NDC 66530-249
Requested package NDC 66530-249-40
11-digit product format 665300249
Labeler code 66530
Product ID 66530-249_d71da1a5-c6a1-45a4-908f-0cd1a21f8537
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fluorouracil
Dosage form CREAM
Route TOPICAL
Labeler Spear Dermatology Products
Application ANDA077524
Marketing category ANDA
Marketing start 2008-04-11
Marketing end 2022-08-31
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 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 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.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FLUOROURACIL ACTIVE INGREDIENT U3P01618RT FLUOROURACIL CREAM [SPEAR DERMATOLOGY PRODUCTS] 2 FLUOROURACIL ACTIVE MOIETY U3P01618RT FLUOROURACIL CREAM [SPEAR DERMATOLOGY PRODUCTS] 2 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN FLUOROURACIL CREAM [SPEAR DERMATOLOGY PRODUCTS] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T FLUOROURACIL CREAM [SPEAR DERMATOLOGY PRODUCTS] 2 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U FLUOROURACIL CREAM [SPEAR DERMATOLOGY PRODUCTS] 2 POLYSORBATE 60 INACTIVE INGREDIENT CAL22UVI4M FLUOROURACIL CREAM [SPEAR DERMATOLOGY PRODUCTS] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 FLUOROURACIL CREAM [SPEAR DERMATOLOGY PRODUCTS] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH FLUOROURACIL CREAM [SPEAR DERMATOLOGY PRODUCTS] 2 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y FLUOROURACIL CREAM [SPEAR DERMATOLOGY PRODUCTS] 2 WATER INACTIVE INGREDIENT 059QF0KO0R FLUOROURACIL CREAM [SPEAR DERMATOLOGY PRODUCTS] 2 FLUOROURACIL ACTIVE INGREDIENT U3P01618RT FLUOROURACIL CREAM [REBEL DISTRIBUTORS CORP] 1 FLUOROURACIL ACTIVE INGREDIENT U3P01618RT FLUOROURACIL (FLUOROURACIL) CREAM [PHYSICIANS TOTAL CARE, INC.] 1 FLUOROURACIL ACTIVE MOIETY U3P01618RT FLUOROURACIL CREAM [REBEL DISTRIBUTORS CORP] 1 FLUOROURACIL ACTIVE MOIETY U3P01618RT FLUOROURACIL (FLUOROURACIL) CREAM [PHYSICIANS TOTAL CARE, INC.] 1 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN FLUOROURACIL CREAM [REBEL DISTRIBUTORS CORP] 1 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN FLUOROURACIL (FLUOROURACIL) CREAM [PHYSICIANS TOTAL CARE, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T FLUOROURACIL (FLUOROURACIL) CREAM [PHYSICIANS TOTAL CARE, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T FLUOROURACIL CREAM [REBEL DISTRIBUTORS CORP] 1 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U FLUOROURACIL CREAM [REBEL DISTRIBUTORS CORP] 1 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U FLUOROURACIL (FLUOROURACIL) CREAM [PHYSICIANS TOTAL CARE, INC.] 1 POLYSORBATE 60 INACTIVE INGREDIENT CAL22UVI4M FLUOROURACIL (FLUOROURACIL) CREAM [PHYSICIANS TOTAL CARE, INC.] 1 POLYSORBATE 60 INACTIVE INGREDIENT CAL22UVI4M FLUOROURACIL CREAM [REBEL DISTRIBUTORS CORP] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 FLUOROURACIL CREAM [REBEL DISTRIBUTORS CORP] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 FLUOROURACIL (FLUOROURACIL) CREAM [PHYSICIANS TOTAL CARE, INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH FLUOROURACIL CREAM [REBEL DISTRIBUTORS CORP] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH FLUOROURACIL (FLUOROURACIL) CREAM [PHYSICIANS TOTAL CARE, INC.] 1 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y FLUOROURACIL CREAM [REBEL DISTRIBUTORS CORP] 1 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y FLUOROURACIL (FLUOROURACIL) CREAM [PHYSICIANS TOTAL CARE, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R FLUOROURACIL CREAM [REBEL DISTRIBUTORS CORP] 1 WATER INACTIVE INGREDIENT 059QF0KO0R FLUOROURACIL (FLUOROURACIL) CREAM [PHYSICIANS TOTAL CARE, INC.] 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 · 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 66530-249-40 66530024940 40 g in 1 TUBE (66530-249-40) 40 g 2008-04-11 2022-08-31 No No Current