Home NDC 84549-117 Fluorouracil
Product NDC 84549-117
11-digit product format 845490117
Labeler code 84549
Product ID 84549-117_43057fcd-1f86-cc1a-e063-6294a90a8d24
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FLUOROURACIL
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler ProPharma Distribution
Application ANDA040279
Marketing category ANDA
Marketing start 2017-01-02
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 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040279-001 FLUOROURACIL FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP RS 1998-09-30 A040279-002 FLUOROURACIL FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP RS 1998-09-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 A040279-001 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP RS 1998-09-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040279-002 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP RS 1998-09-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040279-001 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP RS 1998-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040279-002 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP RS 1998-09-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040279-001 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP RS 1998-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040279-002 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP RS 1998-09-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040279-001 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP RS 1998-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040279-002 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP RS 1998-09-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040279-001 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 1998-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040279-002 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 1998-09-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040279-001 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 1998-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040279-002 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 1998-09-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040279-001 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 1998-09-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040279-002 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 1998-09-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040279-001 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 1998-09-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040279-002 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 1998-09-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040279-001 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 1998-09-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040279-002 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 1998-09-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040279-001 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 1998-09-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040279-002 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 1998-09-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040279-001 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 1998-09-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040279-002 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 1998-09-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040279-001 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 1998-09-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040279-002 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 1998-09-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040279-001 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 1998-09-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040279-002 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 1998-09-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040279-001 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 1998-09-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040279-002 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 1998-09-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040279-001 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 1998-09-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A040279-002 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 1998-09-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040279-001 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 1998-09-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040279-002 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 1998-09-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040279-001 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 1998-09-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A040279-002 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 1998-09-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040279-001 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 1998-09-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A040279-002 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 1998-09-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040279-001 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP RS 1998-09-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A040279-002 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP RS 1998-09-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040279-001 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 1998-09-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A040279-002 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 1998-09-30 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Fluorouracil
Listing expiration 2026-12-31 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 1791701 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 84549-117-10 Fluorouracil 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 10 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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Fluorouracil FLUOROURACIL Fresenius Kabi USA, LLC a85ab26a-05ea-498f-8f34-564a925fa9d9 2026-06-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 040279 application number: ANDA040279 Fluorouracil FLUOROURACIL Fresenius Kabi USA, LLC c45f5286-a52b-43e5-8a6f-d0312e7da0c8 2026-03-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 040279 application number: ANDA040279 Fluorouracil FLUOROURACIL ProPharma Distribution 43057fcd-1f87-cc1a-e063-6294a90a8d24 2025-11-07 Warnings, Adverse reactions Exact identifier application applno (ANDA): 040279 application number: ANDA040279 ndc (product): 84549-117 Fluorouracil FLUOROURACIL Fresenius Kabi USA, LLC fdf2a165-2ca4-48be-89c1-570e6010b47c 2025-06-11 Warnings, Adverse reactions Exact identifier application applno (ANDA): 040279 application number: ANDA040279
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84549-117-10 84549011710 10 mL in 1 VIAL, SINGLE-DOSE (84549-117-10) 10 ml 2025-10-10 No No Current