Application 065294

Type: ANDA
Sponsor: CEPHAZONE PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFTRIAXONE	CEFTRIAXONE SODIUM	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	EQ 250MG BASE/VIAL	No	No
002	CEFTRIAXONE	CEFTRIAXONE SODIUM	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	EQ 500MG BASE/VIAL	No	No
003	CEFTRIAXONE	CEFTRIAXONE SODIUM	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	EQ 1GM BASE/VIAL	No	No
004	CEFTRIAXONE	CEFTRIAXONE SODIUM	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	EQ 2GM BASE/VIAL	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A065294-001	CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26
A065294-002	CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26
A065294-003	CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26
A065294-004	CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26

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 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A065294-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065294-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065294-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065294-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065294-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065294-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065294-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065294-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065294-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065294-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065294-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065294-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065294-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065294-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065294-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065294-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065294-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065294-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065294-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065294-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065294-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065294-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065294-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065294-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065294-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065294-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065294-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065294-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065294-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065294-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065294-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065294-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065294-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065294-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065294-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065294-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065294-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065294-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065294-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065294-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2007-03-26	`5bbf6a4d5a75…`

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 2 · 34 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Sportpharm LLC	ddbc3bf6-5bab-4851-ae5a-ef263cd8f255	2026-07-23	Warnings, Adverse reactions	Name fallback generic name: CEFTRIAXONE SODIUM
Ceftriaxone	CEFTRIAXONE	WG Critical Care, LLC	86ec0a92-a552-4a6d-9125-a54f95e43392	2026-06-18	Warnings, Adverse reactions	Name fallback brand name: Ceftriaxone
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Sportpharm LLC	85ce4f8b-77e0-48bf-9f57-93f1478befa2	2026-04-24	Warnings, Adverse reactions	Name fallback generic name: CEFTRIAXONE SODIUM
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Sportpharm LLC	9a937e47-8c36-4656-83e1-b3c18ed9bac3	2026-04-24	Warnings, Adverse reactions	Name fallback generic name: CEFTRIAXONE SODIUM
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	REMEDYREPACK INC.	9c801096-ca61-4b29-a1e1-5f7e7813b191	2026-02-06	Warnings, Adverse reactions	Name fallback generic name: CEFTRIAXONE SODIUM
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Qilu Pharmaceutical Co., Ltd.	4cdf0743-c62b-4969-b9c9-4c6400644f6c	2026-02-04	Warnings, Adverse reactions	Name fallback generic name: CEFTRIAXONE SODIUM
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Hospira, Inc	128bb292-d174-4769-b3e6-9f16617f31e3	2026-01-22	Warnings, Adverse reactions	Name fallback generic name: CEFTRIAXONE SODIUM
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Hospira, Inc	19141ccd-e66c-49a2-a794-0616028495a7	2026-01-19	Warnings, Adverse reactions	Name fallback generic name: CEFTRIAXONE SODIUM
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Hospira, Inc	03283208-8616-4117-9d2b-aa8046017a4f	2026-01-19	Warnings, Adverse reactions	Name fallback generic name: CEFTRIAXONE SODIUM
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Hospira, Inc	365fc265-8e6c-432f-9fda-911f5f7fb451	2026-01-16	Warnings, Adverse reactions	Name fallback generic name: CEFTRIAXONE SODIUM
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Hospira, Inc	36c07ebf-b091-483e-b2c4-f0fc0c2b4186	2026-01-16	Warnings, Adverse reactions	Name fallback generic name: CEFTRIAXONE SODIUM
Ceftriaxone	CEFTRIAXONE	WG Critical Care, LLC	7bed9b33-29e3-4f04-9766-43a21c7ad47a	2026-01-07	Warnings, Adverse reactions	Name fallback brand name: Ceftriaxone
Ceftriaxone	CEFTRIAXONE	WG Critical Care, LLC	befd73ff-cb3b-4543-8a8e-bdb9b7fc1ff0	2025-04-07	Warnings, Adverse reactions	Name fallback brand name: Ceftriaxone
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Sandoz Inc	53df951b-2eee-44b1-bae2-df7ed85bc0ed	2025-02-28	Warnings, Adverse reactions	Name fallback generic name: CEFTRIAXONE SODIUM
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Sandoz Inc	de028434-46cf-44f6-8ac6-889c7c6943b3	2025-02-27	Warnings, Adverse reactions	Name fallback generic name: CEFTRIAXONE SODIUM
Ceftriaxone	CEFTRIAXONE SODIUM	Baxter Healthcare Company	4c5c2d3f-5038-41a1-a2fe-4dcd048dbac1	2024-10-07	Warnings, Adverse reactions	Name fallback brand name: Ceftriaxone generic name: CEFTRIAXONE SODIUM
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	A-S Medication Solutions	53415af6-4072-4339-83e2-d870ae02a0e2	2024-08-20	Warnings, Adverse reactions	Name fallback generic name: CEFTRIAXONE SODIUM
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	A-S Medication Solutions	b642877e-0d36-4218-afe9-0a39f35b571d	2024-03-27	Warnings, Adverse reactions	Name fallback generic name: CEFTRIAXONE SODIUM
Ceftriaxone	CEFTRIAXONE	Civica, Inc.	96f3fc1e-84f4-4e9b-91ac-19a1692f227a	2024-02-06	Warnings, Adverse reactions	Name fallback brand name: Ceftriaxone
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Proficient Rx LP	790279d4-2456-4091-abec-960b78885432	2024-02-01	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.

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
68330-001	Ceftriaxone	Ceftriaxone	Cephazone Pharma LLC	ANDA	Current
68330-002	Ceftriaxone	Ceftriaxone	Cephazone Pharma LLC	ANDA	Current
68330-003	Ceftriaxone	Ceftriaxone	Cephazone Pharma LLC	ANDA	Current
68330-004	Ceftriaxone	Ceftriaxone	Cephazone Pharma LLC	ANDA	Current
68330-005	Ceftriaxone	Ceftriaxone	Cephazone Pharma LLC	ANDA	Current
68330-006	Ceftriaxone	Ceftriaxone	Cephazone Pharma LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
23745	ORIG	2008-09-19