Fluorouracil

Product NDC: 63323-117
Requested package NDC: 63323-117-28
11-digit product format: 633230117
Labeler code: 63323
Product ID: 63323-117_0c579d19-82e7-4aac-bcb6-b3a60a3b48a3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: FLUOROURACIL
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
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: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63323-117	63323-117-28	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63323-117	63323-117-28	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63323-117	63323-117-28	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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.

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 · 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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2022-03-09 01:35 UTC	2022-03	A040279-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040279-002	AP	1	`bb7c543d1eb4…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c45f5286-a52b-43e5-8a6f-d0312e7da0c8	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	SPL version
63323-117-00	Fluorouracil	10 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	10	10
63323-117-01	Fluorouracil	20 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	20	10
63323-117-10	Fluorouracil	10 in 1 TRAY	INJECTION, SOLUTION	10	10
63323-117-20	Fluorouracil	10 in 1 TRAY	INJECTION, SOLUTION	10	10
63323-117-51	Fluorouracil	1 in 1 CARTON	INJECTION, SOLUTION	1	6
63323-117-51	Fluorouracil	50 mL in 1 VIAL, PHARMACY BULK PACKAGE	INJECTION, SOLUTION	50	6
63323-117-61	Fluorouracil	100 mL in 1 VIAL, PHARMACY BULK PACKAGE	INJECTION, SOLUTION	100	6
63323-117-61	Fluorouracil	1 in 1 CARTON	INJECTION, SOLUTION	1	6
63323-117-18	Fluorouracil	10 in 1 TRAY	INJECTION, SOLUTION	10	5
63323-117-19	Fluorouracil	10 in 1 TRAY	INJECTION, SOLUTION	10	5
63323-117-28	Fluorouracil	10 in 1 TRAY	INJECTION, SOLUTION	10	5
63323-117-31	Fluorouracil	10 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	10	5
63323-117-41	Fluorouracil	20 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	20	5
63323-117-43	Fluorouracil	10 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	10	5
63323-117-58	Fluorouracil	50 mL in 1 VIAL, PHARMACY BULK PACKAGE	INJECTION, SOLUTION	50	5
63323-117-58	Fluorouracil	1 in 1 CARTON	INJECTION, SOLUTION	1	5
63323-117-68	Fluorouracil	1 in 1 CARTON	INJECTION, SOLUTION	1	5
63323-117-68	Fluorouracil	100 mL in 1 VIAL, PHARMACY BULK PACKAGE	INJECTION, SOLUTION	100	5
63323-117-59	Fluorouracil	1 in 1 CARTON	INJECTION, SOLUTION	1	4
63323-117-59	Fluorouracil	50 mL in 1 VIAL, PHARMACY BULK PACKAGE	INJECTION, SOLUTION	50	4
63323-117-69	Fluorouracil	1 in 1 CARTON	INJECTION, SOLUTION	1	4
63323-117-69	Fluorouracil	100 mL in 1 VIAL, PHARMACY BULK PACKAGE	INJECTION, SOLUTION	100	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-117-00	ML - Milliliter	63323-117	267f8c91-9271-4391-8413-b8534354b9bb	1	2021-06-02
63323-117-01	ML - Milliliter	63323-117	25630258-6f5e-4e82-98db-d6667281b1cd	1	2021-10-08
63323-117-10	ML - Milliliter	63323-117	b86648e5-1e8a-4a65-a398-fb7db9da36f9	1	2012-07-24
63323-117-18	ML - Milliliter	63323-117	a8ce7c14-50ae-4b07-9b35-da999bf9c0e5	1	2014-10-03
63323-117-19	ML - Milliliter	63323-117	61608534-5005-4a4b-ba86-98c7249fc58f	1	2014-07-02
63323-117-20	ML - Milliliter	63323-117	27b634db-662c-4a9d-9386-a196824f0fa0	1	2012-07-24
63323-117-28	ML - Milliliter	63323-117	d7d2e357-2980-494b-bf20-ca90f62d27d2	1	2014-10-03
63323-117-31	ML - Milliliter	63323-117	d7082dec-2d1e-45dd-8c82-8806774751de	1	2021-10-08
63323-117-41	ML - Milliliter	63323-117	b489ed5f-459d-4062-8483-e01ec52b0182	1	2021-11-09
63323-117-43	ML - Milliliter	63323-117	90156463-0404-45a1-9890-9562e9faf7d5	1	2022-09-12
63323-117-51	ML - Milliliter	63323-117	2597a576-0566-45e0-9735-1a28c6574fcb	1	2013-02-13
63323-117-58	ML - Milliliter	63323-117	637d5028-3696-4710-af67-df86d5259382	1	2014-10-03
63323-117-59	ML - Milliliter	63323-117	c9225942-73ea-4111-be14-c910b277b1e7	1	2014-07-02
63323-117-61	ML - Milliliter	63323-117	95dbcf0a-7f3a-4bb9-8ac8-5d11ab9bd39b	1	2013-02-13
63323-117-68	ML - Milliliter	63323-117	ac74a78b-73ec-4052-b0b1-a5b1e0befb11	1	2014-10-03
63323-117-69	ML - Milliliter	63323-117	570693b7-ae18-4fc2-a2e1-8ead6b0c1bad	1	2014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUOROURACIL	ACTIVE INGREDIENT	U3P01618RT	FLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	2
FLUOROURACIL	ACTIVE INGREDIENT	U3P01618RT	FLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	2
FLUOROURACIL	ACTIVE INGREDIENT	U3P01618RT	FLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	2
FLUOROURACIL	ACTIVE MOIETY	U3P01618RT	FLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	2
FLUOROURACIL	ACTIVE MOIETY	U3P01618RT	FLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	2
FLUOROURACIL	ACTIVE MOIETY	U3P01618RT	FLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	FLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	FLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	FLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	2
FLUOROURACIL	ACTIVE INGREDIENT	U3P01618RT	FLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
FLUOROURACIL	ACTIVE INGREDIENT	U3P01618RT	FLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
FLUOROURACIL	ACTIVE INGREDIENT	U3P01618RT	FLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
FLUOROURACIL	ACTIVE MOIETY	U3P01618RT	FLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
FLUOROURACIL	ACTIVE MOIETY	U3P01618RT	FLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
FLUOROURACIL	ACTIVE MOIETY	U3P01618RT	FLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	FLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	FLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	FLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-117	FLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	8	Current NDC, Legacy NDC, 4 package rows	20241013_c45f5286-a52b-43e5-8a6f-d0312e7da0c8.zip
63323-117	FLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	5	Current NDC, Legacy NDC, 4 package rows	20250129_21af1777-87f7-4e40-9917-f1677e7ff1a5.zip
63323-117	FLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	5	Current NDC, Legacy NDC, 4 package rows	20241122_beb8c6c5-4b6e-4770-b6d4-718e33c7a2ff.zip
63323-117	FLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	4	Current NDC, Legacy NDC, 4 package rows	20241013_a85ab26a-05ea-498f-8f34-564a925fa9d9.zip
63323-117	FLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	4	Current NDC, Legacy NDC, 2 package rows	20241013_fdf2a165-2ca4-48be-89c1-570e6010b47c.zip
63323-117	FLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	4	Current NDC, Legacy NDC, 4 package rows	20250129_b4328ae3-f48f-40b1-9719-1c1aced7c734.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluorouracil	FLUOROURACIL	Fresenius Kabi USA, LLC	beb8c6c5-4b6e-4770-b6d4-718e33c7a2ff	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 63323-117
Fluorouracil	FLUOROURACIL	Fresenius Kabi USA, LLC	b4328ae3-f48f-40b1-9719-1c1aced7c734	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 63323-117
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 ndc (package): 63323-117-28 ndc (product): 63323-117 ndc11 (package): 63323011728
Fluorouracil	FLUOROURACIL	Fresenius Kabi USA, LLC	21af1777-87f7-4e40-9917-f1677e7ff1a5	2026-06-08	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 63323-117
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 ndc (product): 63323-117
Fluorouracil	FLUOROURACIL	ProPharma Distribution	43057fcd-1f87-cc1a-e063-6294a90a8d24	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040279 application number: ANDA040279
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 ndc (product): 63323-117

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
1791736	fluorouracil 1 GM in 20 ML Injection	PSN	c45f5286-a52b-43e5-8a6f-d0312e7da0c8	10
239177	fluorouracil 50 MG/ML Injectable Solution	PSN	c45f5286-a52b-43e5-8a6f-d0312e7da0c8	10
1791701	fluorouracil 500 MG in 10 ML Injection	PSN	c45f5286-a52b-43e5-8a6f-d0312e7da0c8	10
1791701	10 ML fluorouracil 50 MG/ML Injection	SCD	c45f5286-a52b-43e5-8a6f-d0312e7da0c8	10
1791736	20 ML fluorouracil 50 MG/ML Injection	SCD	c45f5286-a52b-43e5-8a6f-d0312e7da0c8	10
239177	fluorouracil 50 MG/ML Injectable Solution	SCD	c45f5286-a52b-43e5-8a6f-d0312e7da0c8	10
1791701	10 ML 5-5-fluorouracil 50 MG/ML Injection	SY	c45f5286-a52b-43e5-8a6f-d0312e7da0c8	10
1791701	10 ML 5-FU 50 MG/ML Injection	SY	c45f5286-a52b-43e5-8a6f-d0312e7da0c8	10
1791736	20 ML 5-5-fluorouracil 50 MG/ML Injection	SY	c45f5286-a52b-43e5-8a6f-d0312e7da0c8	10
1791736	20 ML 5-FU 50 MG/ML Injection	SY	c45f5286-a52b-43e5-8a6f-d0312e7da0c8	10
239177	5-5-fluorouracil 50 MG/ML Injectable Solution	SY	c45f5286-a52b-43e5-8a6f-d0312e7da0c8	10
239177	5-FU 50 MG/ML Injectable Solution	SY	c45f5286-a52b-43e5-8a6f-d0312e7da0c8	10
239177	fluorouracil (as fluorouracil sodium) 50 MG/ML Injectable Solution	SY	c45f5286-a52b-43e5-8a6f-d0312e7da0c8	10
1791736	fluorouracil 1 GM per 20 ML Injection	SY	c45f5286-a52b-43e5-8a6f-d0312e7da0c8	10
239177	fluorouracil 2.5 GM per 50 ML Injectable Solution	SY	c45f5286-a52b-43e5-8a6f-d0312e7da0c8	10
1791701	fluorouracil 500 MG per 10 ML Injection	SY	c45f5286-a52b-43e5-8a6f-d0312e7da0c8	10
1791736	fluorouracil 1 GM in 20 ML Injection	PSN	beb8c6c5-4b6e-4770-b6d4-718e33c7a2ff	6
239177	fluorouracil 50 MG/ML Injectable Solution	PSN	beb8c6c5-4b6e-4770-b6d4-718e33c7a2ff	6
1791701	fluorouracil 500 MG in 10 ML Injection	PSN	beb8c6c5-4b6e-4770-b6d4-718e33c7a2ff	6
1791701	10 ML fluorouracil 50 MG/ML Injection	SCD	beb8c6c5-4b6e-4770-b6d4-718e33c7a2ff	6
1791736	20 ML fluorouracil 50 MG/ML Injection	SCD	beb8c6c5-4b6e-4770-b6d4-718e33c7a2ff	6
239177	fluorouracil 50 MG/ML Injectable Solution	SCD	beb8c6c5-4b6e-4770-b6d4-718e33c7a2ff	6
1791701	10 ML 5-5-fluorouracil 50 MG/ML Injection	SY	beb8c6c5-4b6e-4770-b6d4-718e33c7a2ff	6
1791701	10 ML 5-FU 50 MG/ML Injection	SY	beb8c6c5-4b6e-4770-b6d4-718e33c7a2ff	6
1791736	20 ML 5-5-fluorouracil 50 MG/ML Injection	SY	beb8c6c5-4b6e-4770-b6d4-718e33c7a2ff	6
1791736	20 ML 5-FU 50 MG/ML Injection	SY	beb8c6c5-4b6e-4770-b6d4-718e33c7a2ff	6
239177	5-5-fluorouracil 50 MG/ML Injectable Solution	SY	beb8c6c5-4b6e-4770-b6d4-718e33c7a2ff	6
239177	5-FU 50 MG/ML Injectable Solution	SY	beb8c6c5-4b6e-4770-b6d4-718e33c7a2ff	6
239177	fluorouracil (as fluorouracil sodium) 50 MG/ML Injectable Solution	SY	beb8c6c5-4b6e-4770-b6d4-718e33c7a2ff	6
1791736	fluorouracil 1 GM per 20 ML Injection	SY	beb8c6c5-4b6e-4770-b6d4-718e33c7a2ff	6
239177	fluorouracil 2.5 GM per 50 ML Injectable Solution	SY	beb8c6c5-4b6e-4770-b6d4-718e33c7a2ff	6
1791701	fluorouracil 500 MG per 10 ML Injection	SY	beb8c6c5-4b6e-4770-b6d4-718e33c7a2ff	6
1791736	fluorouracil 1 GM in 20 ML Injection	PSN	21af1777-87f7-4e40-9917-f1677e7ff1a5	5
1791736	fluorouracil 1 GM in 20 ML Injection	PSN	a85ab26a-05ea-498f-8f34-564a925fa9d9	5
1791736	fluorouracil 1 GM in 20 ML Injection	PSN	fdf2a165-2ca4-48be-89c1-570e6010b47c	5
239177	fluorouracil 50 MG/ML Injectable Solution	PSN	a85ab26a-05ea-498f-8f34-564a925fa9d9	5
239177	fluorouracil 50 MG/ML Injectable Solution	PSN	fdf2a165-2ca4-48be-89c1-570e6010b47c	5
239177	fluorouracil 50 MG/ML Injectable Solution	PSN	21af1777-87f7-4e40-9917-f1677e7ff1a5	5
1791701	fluorouracil 500 MG in 10 ML Injection	PSN	fdf2a165-2ca4-48be-89c1-570e6010b47c	5
1791701	fluorouracil 500 MG in 10 ML Injection	PSN	a85ab26a-05ea-498f-8f34-564a925fa9d9	5
1791701	fluorouracil 500 MG in 10 ML Injection	PSN	21af1777-87f7-4e40-9917-f1677e7ff1a5	5
1791701	10 ML fluorouracil 50 MG/ML Injection	SCD	21af1777-87f7-4e40-9917-f1677e7ff1a5	5
1791701	10 ML fluorouracil 50 MG/ML Injection	SCD	a85ab26a-05ea-498f-8f34-564a925fa9d9	5
1791701	10 ML fluorouracil 50 MG/ML Injection	SCD	fdf2a165-2ca4-48be-89c1-570e6010b47c	5
1791736	20 ML fluorouracil 50 MG/ML Injection	SCD	fdf2a165-2ca4-48be-89c1-570e6010b47c	5
1791736	20 ML fluorouracil 50 MG/ML Injection	SCD	21af1777-87f7-4e40-9917-f1677e7ff1a5	5
1791736	20 ML fluorouracil 50 MG/ML Injection	SCD	a85ab26a-05ea-498f-8f34-564a925fa9d9	5
239177	fluorouracil 50 MG/ML Injectable Solution	SCD	21af1777-87f7-4e40-9917-f1677e7ff1a5	5
239177	fluorouracil 50 MG/ML Injectable Solution	SCD	fdf2a165-2ca4-48be-89c1-570e6010b47c	5
239177	fluorouracil 50 MG/ML Injectable Solution	SCD	a85ab26a-05ea-498f-8f34-564a925fa9d9	5
1791701	10 ML 5-5-fluorouracil 50 MG/ML Injection	SY	fdf2a165-2ca4-48be-89c1-570e6010b47c	5
1791701	10 ML 5-5-fluorouracil 50 MG/ML Injection	SY	21af1777-87f7-4e40-9917-f1677e7ff1a5	5
1791701	10 ML 5-5-fluorouracil 50 MG/ML Injection	SY	a85ab26a-05ea-498f-8f34-564a925fa9d9	5
1791701	10 ML 5-FU 50 MG/ML Injection	SY	21af1777-87f7-4e40-9917-f1677e7ff1a5	5
1791701	10 ML 5-FU 50 MG/ML Injection	SY	fdf2a165-2ca4-48be-89c1-570e6010b47c	5
1791701	10 ML 5-FU 50 MG/ML Injection	SY	a85ab26a-05ea-498f-8f34-564a925fa9d9	5
1791736	20 ML 5-5-fluorouracil 50 MG/ML Injection	SY	fdf2a165-2ca4-48be-89c1-570e6010b47c	5
1791736	20 ML 5-5-fluorouracil 50 MG/ML Injection	SY	a85ab26a-05ea-498f-8f34-564a925fa9d9	5
1791736	20 ML 5-5-fluorouracil 50 MG/ML Injection	SY	21af1777-87f7-4e40-9917-f1677e7ff1a5	5
1791736	20 ML 5-FU 50 MG/ML Injection	SY	a85ab26a-05ea-498f-8f34-564a925fa9d9	5
1791736	20 ML 5-FU 50 MG/ML Injection	SY	21af1777-87f7-4e40-9917-f1677e7ff1a5	5
1791736	20 ML 5-FU 50 MG/ML Injection	SY	fdf2a165-2ca4-48be-89c1-570e6010b47c	5
239177	5-5-fluorouracil 50 MG/ML Injectable Solution	SY	fdf2a165-2ca4-48be-89c1-570e6010b47c	5
239177	5-5-fluorouracil 50 MG/ML Injectable Solution	SY	a85ab26a-05ea-498f-8f34-564a925fa9d9	5
239177	5-5-fluorouracil 50 MG/ML Injectable Solution	SY	21af1777-87f7-4e40-9917-f1677e7ff1a5	5
239177	5-FU 50 MG/ML Injectable Solution	SY	a85ab26a-05ea-498f-8f34-564a925fa9d9	5
239177	5-FU 50 MG/ML Injectable Solution	SY	21af1777-87f7-4e40-9917-f1677e7ff1a5	5
239177	5-FU 50 MG/ML Injectable Solution	SY	fdf2a165-2ca4-48be-89c1-570e6010b47c	5
239177	fluorouracil (as fluorouracil sodium) 50 MG/ML Injectable Solution	SY	21af1777-87f7-4e40-9917-f1677e7ff1a5	5
239177	fluorouracil (as fluorouracil sodium) 50 MG/ML Injectable Solution	SY	a85ab26a-05ea-498f-8f34-564a925fa9d9	5
239177	fluorouracil (as fluorouracil sodium) 50 MG/ML Injectable Solution	SY	fdf2a165-2ca4-48be-89c1-570e6010b47c	5
1791736	fluorouracil 1 GM per 20 ML Injection	SY	21af1777-87f7-4e40-9917-f1677e7ff1a5	5
1791736	fluorouracil 1 GM per 20 ML Injection	SY	fdf2a165-2ca4-48be-89c1-570e6010b47c	5
1791736	fluorouracil 1 GM per 20 ML Injection	SY	a85ab26a-05ea-498f-8f34-564a925fa9d9	5
239177	fluorouracil 2.5 GM per 50 ML Injectable Solution	SY	fdf2a165-2ca4-48be-89c1-570e6010b47c	5
239177	fluorouracil 2.5 GM per 50 ML Injectable Solution	SY	21af1777-87f7-4e40-9917-f1677e7ff1a5	5
239177	fluorouracil 2.5 GM per 50 ML Injectable Solution	SY	a85ab26a-05ea-498f-8f34-564a925fa9d9	5
1791701	fluorouracil 500 MG per 10 ML Injection	SY	fdf2a165-2ca4-48be-89c1-570e6010b47c	5
1791701	fluorouracil 500 MG per 10 ML Injection	SY	a85ab26a-05ea-498f-8f34-564a925fa9d9	5
1791701	fluorouracil 500 MG per 10 ML Injection	SY	21af1777-87f7-4e40-9917-f1677e7ff1a5	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-117-28	63323011728	10 VIAL, SINGLE-DOSE in 1 TRAY (63323-117-28) > 20 mL in 1 VIAL, SINGLE-DOSE (63323-117-41)	2000-07-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluorouracil	Fresenius Kabi USA, LLC	2026-07-15	HUMAN PRESCRIPTION DRUG LABEL	7
Fluorouracil	Fresenius Kabi USA, LLC	2026-06-10	HUMAN PRESCRIPTION DRUG LABEL	5
Fluorouracil	Fresenius Kabi USA, LLC	2026-06-09	HUMAN PRESCRIPTION DRUG LABEL	6
Fluorouracil	Fresenius Kabi USA, LLC	2026-06-08	HUMAN PRESCRIPTION DRUG LABEL	6
Fluorouracil	Fresenius Kabi USA, LLC	2026-03-19	HUMAN PRESCRIPTION DRUG LABEL	10
Fluorouracil	ProPharma Distribution	2025-11-07	HUMAN PRESCRIPTION DRUG LABEL	1
Fluorouracil	Fresenius Kabi USA, LLC	2025-06-11	HUMAN PRESCRIPTION DRUG LABEL	5