Application 050796

Type: NDA
Sponsor: B BRAUN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	CEFTRIAXONE SODIUM	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	Yes	Yes
002	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	CEFTRIAXONE 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
N050796-001	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	CEFTRIAXONE SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-20
N050796-002	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	CEFTRIAXONE SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050796-001	AP
N050796-002	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	N050796-001	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050796-002	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050796-001	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050796-002	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050796-001	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050796-002	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050796-001	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050796-002	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050796-001	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050796-002	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050796-001	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050796-002	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050796-001	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050796-002	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050796-001	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050796-002	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050796-001	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050796-002	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050796-001	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050796-002	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050796-001	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050796-002	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050796-001	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050796-002	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050796-001	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050796-002	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050796-001	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050796-002	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050796-001	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050796-002	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050796-001	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050796-002	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050796-001	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050796-002	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050796-001	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050796-002	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050796-001	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050796-002	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050796-001	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050796-002	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-20	`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	N050796-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050796-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050796-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050796-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050796-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050796-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050796-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050796-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050796-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050796-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050796-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050796-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050796-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050796-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050796-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050796-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050796-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050796-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050796-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050796-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050796-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050796-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050796-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050796-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050796-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050796-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050796-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050796-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050796-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050796-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050796-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050796-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050796-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050796-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050796-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050796-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050796-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050796-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050796-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050796-002	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
CEFTRIAXONE AND DEXTROSE	CEFTRIAXONE	B. Braun Medical Inc.	67153914-16bc-490d-82d7-638061618467	2022-01-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050796 application number: NDA050796 ndc (product): 0264-3153 ndc (product): 0264-3155

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0264-3153	CEFTRIAXONE AND DEXTROSE	CEFTRIAXONE	B. Braun Medical Inc.	NDA	Current
0264-3153	CEFTRIAXONE AND DEXTROSE	CEFTRIAXONE	B. Braun Medical Inc.	NDA	Current
0264-3153	CEFTRIAXONE AND DEXTROSE	CEFTRIAXONE	B. Braun Medical Inc.	NDA	Current
0264-3153	CEFTRIAXONE AND DEXTROSE	CEFTRIAXONE	B. Braun Medical Inc.	NDA	Current
0264-3155	CEFTRIAXONE AND DEXTROSE	CEFTRIAXONE	B. Braun Medical Inc.	NDA	Current
0264-3155	CEFTRIAXONE AND DEXTROSE	CEFTRIAXONE	B. Braun Medical Inc.	NDA	Current
0264-3155	CEFTRIAXONE AND DEXTROSE	CEFTRIAXONE	B. Braun Medical Inc.	NDA	Current
0264-3155	CEFTRIAXONE AND DEXTROSE	CEFTRIAXONE	B. Braun Medical Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69888	SUPPL	2022-01-18
69881	SUPPL	2022-01-14
66730	SUPPL	2021-03-10
66707	SUPPL	2021-03-10
64548	SUPPL	2020-09-10
64544	SUPPL	2020-09-10
8313	SUPPL	2015-07-13
18277	SUPPL	2015-07-10
18276	SUPPL	2013-04-16
8312	SUPPL	2013-04-16
30582	SUPPL	2013-03-13
39358	SUPPL	2013-03-11
39356	SUPPL	2012-02-07
30581	SUPPL	2012-02-07
39357	SUPPL	2010-07-01
8311	SUPPL	2010-06-30
30580	SUPPL	2008-12-19
8310	SUPPL	2008-12-19
39355	SUPPL	2007-09-11
8309	SUPPL	2007-09-11
42743	ORIG	2007-07-02
18275	ORIG	2005-04-28
8308	ORIG	2005-04-28