Application 065214

Type: NDA
Sponsor: B BRAUN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	CEFOXITIN SODIUM	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	Yes	Yes
002	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	CEFOXITIN SODIUM	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL	Yes	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
N065214-001	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	CEFOXITIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2006-03-10
N065214-002	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	CEFOXITIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2006-03-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N065214-001	AP
N065214-002	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	N065214-001	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2006-03-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N065214-002	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2006-03-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N065214-001	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2006-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N065214-002	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2006-03-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N065214-001	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2006-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N065214-002	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2006-03-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N065214-001	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2006-03-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N065214-002	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2006-03-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N065214-001	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2006-03-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N065214-002	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2006-03-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N065214-001	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2006-03-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N065214-002	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2006-03-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N065214-001	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2006-03-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N065214-002	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2006-03-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N065214-001	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2006-03-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N065214-002	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2006-03-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N065214-001	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2006-03-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N065214-002	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2006-03-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N065214-001	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2006-03-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N065214-002	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2006-03-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N065214-001	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2006-03-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N065214-002	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2006-03-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N065214-001	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2006-03-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N065214-002	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2006-03-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N065214-001	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2006-03-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N065214-002	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2006-03-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N065214-001	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2006-03-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N065214-002	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2006-03-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N065214-001	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2006-03-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N065214-002	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2006-03-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N065214-001	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2006-03-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N065214-002	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2006-03-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N065214-001	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2006-03-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N065214-002	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2006-03-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N065214-001	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2006-03-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N065214-002	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2006-03-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N065214-001	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2006-03-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N065214-002	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2006-03-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N065214-001	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2006-03-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N065214-002	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2006-03-10	`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	N065214-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N065214-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N065214-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N065214-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N065214-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N065214-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N065214-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N065214-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N065214-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N065214-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N065214-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N065214-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N065214-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N065214-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N065214-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N065214-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N065214-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N065214-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N065214-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N065214-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N065214-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N065214-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N065214-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N065214-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N065214-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N065214-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N065214-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N065214-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N065214-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N065214-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N065214-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N065214-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N065214-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N065214-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N065214-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N065214-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N065214-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N065214-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N065214-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N065214-002	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefoxitin and Dextrose	CEFOXITIN SODIUM	B. Braun Medical Inc.	6c7e9485-1ede-411c-8c46-911439332864	2019-07-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 065214 application number: NDA065214 ndc (product): 0264-3123 ndc (product): 0264-3125

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0264-3123	Cefoxitin and Dextrose	CEFOXITIN SODIUM	B. Braun Medical Inc.	NDA	Current
0264-3123	Cefoxitin and Dextrose	CEFOXITIN SODIUM	B. Braun Medical Inc.	NDA	Current
0264-3123	Cefoxitin and Dextrose	CEFOXITIN SODIUM	B. Braun Medical Inc.	NDA	Current
0264-3125	Cefoxitin and Dextrose	CEFOXITIN SODIUM	B. Braun Medical Inc.	NDA	Current
0264-3125	Cefoxitin and Dextrose	CEFOXITIN SODIUM	B. Braun Medical Inc.	NDA	Current
0264-3125	Cefoxitin and Dextrose	CEFOXITIN SODIUM	B. Braun Medical Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
59515	SUPPL	2019-07-30
59504	SUPPL	2019-07-30
18335	SUPPL	2013-06-11
30655	SUPPL	2013-06-06
18334	SUPPL	2010-03-03
18333	SUPPL	2010-02-16