Application 040279

Type: ANDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUOROURACIL	FLUOROURACIL	INJECTABLE;INJECTION	1GM/20ML (50MG/ML)	No	Yes
002	FLUOROURACIL	FLUOROURACIL	INJECTABLE;INJECTION	500MG/10ML (50MG/ML)	No	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.

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…`

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 (product): 63323-117
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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63323-117	Fluorouracil	FLUOROURACIL	Fresenius Kabi USA, LLC	ANDA	Current
63323-117	Fluorouracil	FLUOROURACIL	Fresenius Kabi USA, LLC	ANDA	Current
63323-117	Fluorouracil	FLUOROURACIL	Fresenius Kabi USA, LLC	ANDA	Current
63323-117	Fluorouracil	FLUOROURACIL	Fresenius Kabi USA, LLC	ANDA	Current
63323-117	Fluorouracil	FLUOROURACIL	Fresenius Kabi USA, LLC	ANDA	Current
63323-117	Fluorouracil	FLUOROURACIL	Fresenius Kabi USA, LLC	ANDA	Current
63323-117	Fluorouracil	FLUOROURACIL	Fresenius Kabi USA, LLC	ANDA	Current
63323-117	Fluorouracil	FLUOROURACIL	Fresenius Kabi USA, LLC	ANDA	Current
63323-117	Fluorouracil	FLUOROURACIL	Fresenius Kabi USA, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85223	SUPPL	2026-03-03
85222	SUPPL	2026-03-03
77998	SUPPL	2024-03-27
77965	SUPPL	2024-03-26
29910	ORIG	2004-06-04
17763	ORIG	2004-06-04
22114	ORIG	2003-07-31