Application 050624

Type: NDA
Sponsor: HOFFMANN LA ROCHE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	CEFTRIAXONE SODIUM	INJECTABLE;INJECTION	EQ 10MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	CEFTRIAXONE SODIUM	INJECTABLE;INJECTION	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	CEFTRIAXONE SODIUM	INJECTABLE;INJECTION	EQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N050624-001	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	CEFTRIAXONE SODIUM	EQ 10MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11
N050624-002	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	CEFTRIAXONE SODIUM	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11
N050624-003	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	CEFTRIAXONE SODIUM	EQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N050624-001	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	EQ 10MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050624-002	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050624-003	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	EQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050624-001	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	EQ 10MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050624-002	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050624-003	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	EQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050624-001	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	EQ 10MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050624-002	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050624-003	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	EQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050624-001	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	EQ 10MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050624-002	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050624-003	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	EQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050624-001	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	EQ 10MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050624-002	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050624-003	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	EQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050624-001	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	EQ 10MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050624-002	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050624-003	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	EQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050624-001	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	EQ 10MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050624-002	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050624-003	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	EQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050624-001	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	EQ 10MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050624-002	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050624-003	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	EQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050624-001	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	EQ 10MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050624-002	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050624-003	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	EQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050624-001	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	EQ 10MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050624-002	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050624-003	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	EQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050624-001	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	EQ 10MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050624-002	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050624-003	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	EQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050624-001	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	EQ 10MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050624-002	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050624-003	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	EQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050624-001	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	EQ 10MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050624-002	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050624-003	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	EQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050624-001	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	EQ 10MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-02-11	`301d65b070ca…`

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 2 of 2 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Apotex Corp.	ac03a72c-0e35-40f9-b7fc-081badb5f19c	2023-01-28	Warnings, Adverse reactions	Name fallback generic name: CEFTRIAXONE SODIUM
Ceftriaxone	CEFTRIAXONE SODIUM	Samson Medical Technologies, LLC	5cd2d96f-83e5-4326-ae87-d0ede4ba493a	2023-01-15	Warnings, Adverse reactions	Name fallback generic name: CEFTRIAXONE SODIUM
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Proficient Rx LP	a25ab5ea-c46d-4562-8f7e-0ccffc2ab069	2022-10-01	Warnings, Adverse reactions	Name fallback generic name: CEFTRIAXONE SODIUM
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Proficient Rx LP	42ba7a9d-7d2b-4eac-af59-897151a8c924	2022-05-02	Warnings, Adverse reactions	Name fallback generic name: CEFTRIAXONE SODIUM
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Hospira, Inc	9d1f630b-e759-4395-9d01-ddc90e4fea75	2022-03-09	Warnings, Adverse reactions	Name fallback generic name: CEFTRIAXONE SODIUM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30180	SUPPL	2004-09-15
17939	SUPPL	2004-09-15
39046	SUPPL	2004-09-03
7894	SUPPL	2004-09-03