Application 216109

Type: NDA
Sponsor: HIKMA PHARMACEUTICALS USA, INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ANCEF	CEFAZOLIN	INJECTABLE;INJECTION	EQ 2GM/VIAL	No	No
002	ANCEF	CEFAZOLIN	INJECTABLE;INJECTION	EQ 3GM/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N216109-001	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2022-10-07
N216109-002	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2022-10-07

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 2 · 50 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N216109-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216109-002	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216109-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216109-002	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216109-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216109-002	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216109-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216109-002	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216109-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216109-002	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216109-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216109-002	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216109-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216109-002	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216109-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216109-002	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216109-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216109-002	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216109-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216109-002	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216109-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216109-002	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216109-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216109-002	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216109-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216109-002	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216109-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N216109-002	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216109-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216109-002	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216109-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N216109-002	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N216109-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N216109-002	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216109-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216109-002	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N216109-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N216109-002	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N216109-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N216109-002	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`a67488948f0b…`

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
Cefazolin	CEFAZOLIN	Hikma Pharmaceuticals USA Inc.	6c7761d3-c154-4802-9876-627cd42913f0	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 216109 application number: NDA216109

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80644	SUPPL	2024-12-19
80638	SUPPL	2024-12-19
74642	ORIG	2023-06-28
72297	ORIG	2022-10-11
72292	ORIG	2022-10-11