Home NDC 71288-170 Fluorouracil
Product NDC 71288-170
11-digit product format 712880170
Labeler code 71288
Product ID 71288-170_cb5958dc-12bd-4172-b45e-34b591eb316c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluorouracil
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Meitheal Pharmaceuticals Inc.
Application ANDA216494
Marketing category ANDA
Marketing start 2024-09-24
Substance FLUOROURACIL
Active strength 50 mg/mL
Pharmacologic classes Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 A216494-001 FLUOROURACIL FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION AP 2024-09-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216494-001 AP
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 2026-08-18 06:07:40 2026-07 A216494-001 FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION AP 2024-09-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216494-001 FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION AP 2024-09-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216494-001 FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION AP 2024-09-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216494-001 FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION AP 2024-09-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216494-001 FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION AP 2024-09-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216494-001 FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION AP 2024-09-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216494-001 FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION AP 2024-09-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216494-001 FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION AP 2024-09-24 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216494-001 FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION AP 2024-09-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216494-001 FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION AP 2024-09-24 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216494-001 FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION AP 2024-09-24 a50c72e98297…
Observed Orange Book normalized TE history# 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/mL
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 239177 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 71288-170-75 Fluorouracil 50 mL in 1 VIAL, PHARMACY BULK PACKAGE INJECTION, SOLUTION 50 11 71288-170-75 Fluorouracil 1 in 1 CARTON INJECTION, SOLUTION 1 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71288-170 FLUOROURACIL INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.] 8 Current NDC, 2 package rows 20241004_a0cd6301-c6e0-4b62-8683-39c99913db24.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 Marketing start Sample Exclude flag Status 71288-170-75 71288017075 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (71288-170-75) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE 2024-09-24 No No Current