Cefazolin

Product NDC: 72572-054
11-digit product format: 725720054
Labeler code: 72572
Product ID: 72572-054_290c8b2a-b798-4927-ac77-ff6aed630c6d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefazolin
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Civica, Inc.
Application: NDA216109
Marketing category: NDA
Marketing start: 2026-08-18
Substance: CEFAZOLIN SODIUM
Active strength: 2 g/1
Pharmacologic classes: Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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

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 · 54 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	N216109-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216109-002	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216109-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216109-002	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-10-07	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Cefazolin
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CEFAZOLIN SODIUM	2 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
P380M0454Z	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1665060	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1367568c-7d27-479f-a4c5-58e99942f686	Available on FDA.report

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefazolin	CEFAZOLIN	Civica, Inc.	1367568c-7d27-479f-a4c5-58e99942f686	2025-11-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 216109 application number: NDA216109 ndc (product): 72572-054
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
P380M0454Z	CEFAZOLIN SODIUM	27164-46-1	CEFAZOLIN SODIUM
IHS69L0Y4T	CEFAZOLIN	25953-19-9	Cefazolin

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72572-054-25	72572005425	25 VIAL in 1 CARTON (72572-054-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72572-054-01)	25 vial	2026-08-18	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cefazolin	Civica, Inc. \| HIKMA FARMACEUTICA (PORTUGAL), S.A.	2025-11-01	HUMAN PRESCRIPTION DRUG LABEL	1