Home NDC 16729-276 Fluorouracil
Product NDC 16729-276
11-digit product format 167290276
Labeler code 16729
Product ID 16729-276_4a6723ea-dd4c-3f28-e063-6394a90a7378
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluorouracil
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Accord Healthcare, Inc.
Application ANDA040798
Marketing category ANDA
Marketing start 2014-03-14
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040798-001 FLUOROURACIL FLUOROURACIL 5GM/100ML (50MG/ML) INJECTABLE / INJECTION AP 2007-04-26 A040798-002 FLUOROURACIL FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION 2007-04-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040798-001 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.
Product history page 1 of 3 · 84 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 A040798-001 FLUOROURACIL 5GM/100ML (50MG/ML) INJECTABLE / INJECTION AP 2007-04-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040798-002 FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION 2007-04-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040798-001 FLUOROURACIL 5GM/100ML (50MG/ML) INJECTABLE / INJECTION AP 2007-04-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040798-002 FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION 2007-04-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040798-001 FLUOROURACIL 5GM/100ML (50MG/ML) INJECTABLE / INJECTION AP 2007-04-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040798-002 FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION 2007-04-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040798-001 FLUOROURACIL 5GM/100ML (50MG/ML) INJECTABLE / INJECTION AP 2007-04-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040798-002 FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION 2007-04-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040798-001 FLUOROURACIL 5GM/100ML (50MG/ML) INJECTABLE / INJECTION AP RS 2007-04-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040798-002 FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION AP RS 2007-04-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040798-001 FLUOROURACIL 5GM/100ML (50MG/ML) INJECTABLE / INJECTION AP RS 2007-04-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040798-002 FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION AP RS 2007-04-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040798-001 FLUOROURACIL 5GM/100ML (50MG/ML) INJECTABLE / INJECTION AP RS 2007-04-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040798-002 FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION AP RS 2007-04-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040798-001 FLUOROURACIL 5GM/100ML (50MG/ML) INJECTABLE / INJECTION AP RS 2007-04-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040798-002 FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION AP RS 2007-04-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040798-001 FLUOROURACIL 5GM/100ML (50MG/ML) INJECTABLE / INJECTION AP RS 2007-04-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040798-002 FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION AP RS 2007-04-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040798-001 FLUOROURACIL 5GM/100ML (50MG/ML) INJECTABLE / INJECTION AP RS 2007-04-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040798-002 FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION AP RS 2007-04-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040798-001 FLUOROURACIL 5GM/100ML (50MG/ML) INJECTABLE / INJECTION AP RS 2007-04-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040798-002 FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION AP RS 2007-04-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040798-001 FLUOROURACIL 5GM/100ML (50MG/ML) INJECTABLE / INJECTION AP RS 2007-04-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040798-002 FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION AP RS 2007-04-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040798-001 FLUOROURACIL 5GM/100ML (50MG/ML) INJECTABLE / INJECTION AP RS 2007-04-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040798-002 FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION AP RS 2007-04-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040798-001 FLUOROURACIL 5GM/100ML (50MG/ML) INJECTABLE / INJECTION AP RS 2007-04-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040798-002 FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION AP RS 2007-04-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040798-001 FLUOROURACIL 5GM/100ML (50MG/ML) INJECTABLE / INJECTION AP RS 2007-04-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A040798-002 FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION AP RS 2007-04-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040798-001 FLUOROURACIL 5GM/100ML (50MG/ML) INJECTABLE / INJECTION AP RS 2007-04-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040798-002 FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION AP RS 2007-04-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040798-001 FLUOROURACIL 5GM/100ML (50MG/ML) INJECTABLE / INJECTION AP RS 2007-04-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A040798-002 FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION AP RS 2007-04-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040798-001 FLUOROURACIL 5GM/100ML (50MG/ML) INJECTABLE / INJECTION AP RS 2007-04-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A040798-002 FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION AP RS 2007-04-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040798-001 FLUOROURACIL 5GM/100ML (50MG/ML) INJECTABLE / INJECTION AP RS 2007-04-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A040798-002 FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION AP RS 2007-04-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040798-001 FLUOROURACIL 5GM/100ML (50MG/ML) INJECTABLE / INJECTION AP RS 2007-04-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A040798-002 FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION AP RS 2007-04-26 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 79 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/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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 239177 Internal RxNorm lookup 1791701 Internal RxNorm lookup 1791736 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 16729-276-03 Fluorouracil 10 mL in 1 VIAL INJECTION, SOLUTION 10 6 16729-276-05 Fluorouracil 20 mL in 1 VIAL INJECTION, SOLUTION 20 6 16729-276-67 Fluorouracil 10 in 1 CARTON INJECTION, SOLUTION 10 6 16729-276-68 Fluorouracil 10 in 1 CARTON INJECTION, SOLUTION 10 6 16729-276-11 Fluorouracil 1 in 1 CARTON INJECTION, SOLUTION 1 5 16729-276-11 Fluorouracil 50 mL in 1 VIAL, PHARMACY BULK PACKAGE INJECTION, SOLUTION 50 5 16729-276-38 Fluorouracil 1 in 1 CARTON INJECTION, SOLUTION 1 5 16729-276-38 Fluorouracil 100 mL in 1 VIAL, PHARMACY BULK PACKAGE INJECTION, SOLUTION 100 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FLUOROURACIL ACTIVE INGREDIENT U3P01618RT FLUOROURACIL INJECTION, SOLUTION [ACCORD HEALTHCARE, INC.] 2 Fluorouracil ACTIVE INGREDIENT U3P01618RT FLUOROURACIL INJECTION, SOLUTION [ACCORD HEALTHCARE, INC.] 2 FLUOROURACIL ACTIVE MOIETY U3P01618RT FLUOROURACIL INJECTION, SOLUTION [ACCORD HEALTHCARE, INC.] 2 Fluorouracil ACTIVE MOIETY U3P01618RT FLUOROURACIL INJECTION, SOLUTION [ACCORD HEALTHCARE, INC.] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I FLUOROURACIL INJECTION, SOLUTION [ACCORD HEALTHCARE, INC.] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I FLUOROURACIL INJECTION, SOLUTION [ACCORD HEALTHCARE, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R FLUOROURACIL INJECTION, SOLUTION [ACCORD HEALTHCARE, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R FLUOROURACIL INJECTION, SOLUTION [ACCORD HEALTHCARE, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16729-276 FLUOROURACIL INJECTION, SOLUTION [ACCORD HEALTHCARE, INC.] 5 Current NDC, Legacy NDC, 4 package rows 20240510_66d451fe-2436-494c-80c5-4528c8e34369.zip 16729-276 FLUOROURACIL INJECTION, SOLUTION [ACCORD HEALTHCARE, INC.] 4 Current NDC, Legacy NDC, 4 package rows 20240531_8eff167f-203a-4a81-b2fc-d8773bc3555e.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 16729-276-03 16729027603 10 mL in 1 VIAL 10 ml Historical 16729-276-05 16729027605 20 mL in 1 VIAL 20 ml Historical 16729-276-11 16729027611 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (16729-276-11) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE 2014-03-14 0000-00-00 No No Current 16729-276-38 16729027638 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (16729-276-38) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE 2014-03-14 0000-00-00 No No Current 16729-276-67 16729027667 10 VIAL in 1 CARTON (16729-276-67) / 20 mL in 1 VIAL (16729-276-05) 10 vial 2014-03-14 0000-00-00 No No Current 16729-276-68 16729027668 10 VIAL in 1 CARTON (16729-276-68) / 10 mL in 1 VIAL (16729-276-03) 10 vial 2014-03-25 0000-00-00 No No Current