Home NDC 21922-049 FLUOROURACIL
Product NDC 21922-049
11-digit product format 219220049
Labeler code 21922
Product ID 21922-049_f33d88a4-f57f-45c7-8c13-94d69e4d7931
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluorouracil
Dosage form CREAM
Route TOPICAL
Labeler Encube Ethicals, Inc.
Application ANDA216942
Marketing category ANDA
Marketing start 2025-02-14
Substance FLUOROURACIL
Active strength 2 g/40g
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 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 A216942-001 FLUOROURACIL FLUOROURACIL 5% CREAM / TOPICAL AB 2025-02-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216942-001 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.
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 A216942-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2025-02-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216942-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2025-02-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216942-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2025-02-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216942-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2025-02-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216942-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2025-02-12 b8a1b40f171c…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216942-001 FLUOROURACIL 5% CREAM / TOPICAL AB 2025-02-12 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base FLUOROURACIL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUOROURACIL 2 g/40g
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 21922-049-17 FLUOROURACIL 1 in 1 CARTON CREAM 1 3 21922-049-17 FLUOROURACIL 40 g in 1 TUBE CREAM 40 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21922-049 FLUOROURACIL CREAM [ENCUBE ETHICALS PRIVATE LIMITED] 2 Current NDC, 2 package rows 20250215_30294dd2-40fb-420d-b838-376343308895.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 · 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 21922-049-17 21922004917 1 TUBE in 1 CARTON (21922-049-17) / 40 g in 1 TUBE 1 tube 2025-02-14 No No Current