Fluorouracil

Product NDC: 84549-117
Requested package NDC: 84549-117-10
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 43.

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.

Application-product, TE code table
Application-product	TE code
A040279-001	AP
A040279-002	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 · 86 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
2026-09-14 22:38:34	2026-08	A040279-001	FLUOROURACIL	1GM/20ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	1998-09-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040279-002	FLUOROURACIL	500MG/10ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	1998-09-30	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A040279-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040279-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040279-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040279-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040279-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040279-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040279-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040279-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040279-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040279-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040279-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040279-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040279-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040279-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040279-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040279-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040279-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040279-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040279-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040279-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040279-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040279-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040279-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040279-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040279-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040279-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040279-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040279-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040279-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040279-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040279-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040279-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040279-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040279-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040279-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040279-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040279-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040279-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040279-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040279-002	AP	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
43057fcd-1f87-cc1a-e063-6294a90a8d24	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7dc9482d-9b87-4471-9708-4f1b4585846b	Product name	2	20250723
a2ca0bf8-8306-49cc-93a3-3e6e4137c7cb	Product name	5	20250630
dc0d2364-4811-4665-a3ee-7ed8c7301465	Product name	2	20171219
62fb8671-1693-49d8-8aab-0c1bfdd6794e	Product name	1	20151005
878ca466-81fd-9d24-1349-31baf36065c6	Product name	2	20150506
630d1bc2-ae6b-fd31-1264-c4733e788193	Product name	1	20140508

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 (package): 84549-117-10 ndc (product): 84549-117 ndc11 (package): 84549011710
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U3P01618RT	FLUOROURACIL	51-21-8	FLUOROURACIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1791701	fluorouracil 500 MG in 10 ML Injection	PSN	43057fcd-1f87-cc1a-e063-6294a90a8d24	1
1791701	10 ML fluorouracil 50 MG/ML Injection	SCD	43057fcd-1f87-cc1a-e063-6294a90a8d24	1
1791701	10 ML 5-5-fluorouracil 50 MG/ML Injection	SY	43057fcd-1f87-cc1a-e063-6294a90a8d24	1
1791701	10 ML 5-FU 50 MG/ML Injection	SY	43057fcd-1f87-cc1a-e063-6294a90a8d24	1
1791701	fluorouracil 500 MG per 10 ML Injection	SY	43057fcd-1f87-cc1a-e063-6294a90a8d24	1

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