FLUOROURACIL

Product NDC: 23155-975
11-digit product format: 231550975
Labeler code: 23155
Product ID: 23155-975_158cf5e7-da4b-44df-b2f0-7bc6e82662d7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: FLUOROURACIL
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application: ANDA210124
Marketing category: ANDA
Marketing start: 2026-09-07
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 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
A210124-001	FLUOROURACIL	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP		2017-12-26
A210124-002	FLUOROURACIL	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP		2017-12-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A210124-001	AP
A210124-002	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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A210124-001	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210124-002	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210124-001	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210124-002	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210124-001	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210124-002	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210124-001	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210124-002	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210124-001	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210124-002	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210124-001	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210124-002	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210124-001	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210124-002	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210124-001	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210124-002	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210124-001	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210124-002	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210124-001	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210124-002	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210124-001	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210124-002	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210124-001	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210124-002	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210124-001	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210124-002	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210124-001	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210124-002	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210124-001	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210124-002	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210124-001	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210124-002	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210124-001	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210124-002	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210124-001	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210124-002	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210124-001	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210124-002	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210124-001	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210124-002	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`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	A210124-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210124-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210124-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210124-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210124-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210124-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210124-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210124-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210124-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210124-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210124-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210124-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210124-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210124-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210124-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210124-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210124-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210124-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210124-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210124-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210124-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210124-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210124-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210124-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210124-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210124-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210124-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210124-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210124-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210124-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210124-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210124-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210124-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210124-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210124-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210124-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210124-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210124-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210124-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210124-002	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: 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
b268684b-487f-4716-a2e8-6e6d3e117b14	Available on FDA.report

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FLUOROURACIL	FLUOROURACIL	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	b268684b-487f-4716-a2e8-6e6d3e117b14	2026-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210124 application number: ANDA210124 ndc (product): 23155-975
Fluorouracil	FLUOROURACIL	Xiromed LLC	f4b0cae1-a2fc-2991-d663-3b729503cd1c	2026-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210124 application number: ANDA210124
Fluorouracil	FLUOROURACIL	Gland Pharma Limited	ea3497db-23b9-4ace-9a6f-b54853d04a82	2025-11-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210124 application number: ANDA210124

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
23155-975-31	23155097531	1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (23155-975-31) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE	2026-09-07	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FLUOROURACIL	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	2026-06-02	HUMAN PRESCRIPTION DRUG LABEL	1