Home NDC 16714-178 Fluorouracil
Product NDC 16714-178
11-digit product format 167140178
Labeler code 16714
Product ID 16714-178_7106b404-bb4d-43e4-9809-17bd2e95a63b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluorouracil
Dosage form CREAM
Route TOPICAL
Labeler NORTHSTAR RX LLC
Application ANDA090368
Marketing category ANDA
Marketing start 2010-03-05
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 A090368-001 FLUOROURACIL FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090368-001 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 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090368-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2010-03-05 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 2027-12-31 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 16714-178-01 Fluorouracil 1 in 1 CARTON CREAM 1 1 16714-178-01 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 16714-178 FLUOROURACIL CREAM [NORTHSTAR RX LLC] 1 Current NDC, Legacy NDC, 2 package rows 20211212_52ef5f41-2312-4b55-aa86-abd5bb28b9d3.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 Marketing end Sample Exclude flag Status 16714-178-01 16714017801 1 TUBE in 1 CARTON (16714-178-01) / 40 g in 1 TUBE 1 tube 2021-11-30 0000-00-00 No No Current