Cefazolin

Product NDC: 44567-845
11-digit product format: 445670845
Labeler code: 44567
Product ID: 44567-845_976b22d4-f147-4281-a1af-d87835a9c356
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefazolin
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAVENOUS
Labeler: WG Critical Care, LLC
Application: NDA211413
Marketing category: NDA
Marketing start: 2024-05-10
Substance: CEFAZOLIN SODIUM
Active strength: 3 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 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
N211413-001	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2023-05-08
N211413-002	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2024-03-08

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N211413-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-05-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211413-002	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-03-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211413-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-05-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211413-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-05-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211413-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-05-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211413-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-05-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211413-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-05-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211413-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-05-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211413-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-05-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211413-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-05-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211413-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-05-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211413-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-05-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211413-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-05-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211413-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-05-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211413-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-05-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211413-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-05-08	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211413-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-05-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211413-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-05-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211413-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-05-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211413-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-05-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211413-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-05-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211413-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-05-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211413-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-05-08	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N211413-001	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-05-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N211413-002	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-03-08	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CEFAZOLIN SODIUM	3 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1665060	Internal RxNorm lookup
2630753	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
4f3a9248-a354-4c77-bf5b-9eed38f00219	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4c53c44d-0495-40c1-9f02-9d772dc7a5c7	Product name	1	20250318
53d47d5d-6076-4275-8f76-06d261cff1e8	Product name	1	20231011
9afe2d9a-f7f6-416b-9ddf-b780a2810bd5	Product name	1	20230912
6e62eeca-6666-f31f-9873-48ea9ede8354	Product name	2	20190214
afa25392-d76e-4453-8841-fde3a34824f1	Product name	2	20160309
53cae805-773b-4bc5-a836-3e22e250892e	Product name	1	20150922
05d4c919-c877-4ec4-cb08-9fcbbbfd8c70	Product name	1	20140508
75ba2549-0297-c880-16c8-4fa502c95a9d	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
44567-845-01	Cefazolin	1 in 1 VIAL	INJECTION, POWDER, FOR SOLUTION	1		6
44567-845-25	Cefazolin	25 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	25		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
44567-845-01	EA - Each	44567-845	63dc84a9-8f68-41e1-96ca-540dc01091f9	1	2024-08-12
44567-845-25	EA - Each	44567-845	623f78c2-2e8c-42a4-aad5-6153d3096fcf	1	2024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
44567-845	CEFAZOLIN INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]	4	Current NDC, 2 package rows	20250508_4f3a9248-a354-4c77-bf5b-9eed38f00219.zip

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	WG Critical Care, LLC	4f3a9248-a354-4c77-bf5b-9eed38f00219	2026-02-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211413 application number: NDA211413 ndc (product): 44567-845

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1665060	ceFAZolin 2 GM Injection	PSN	4f3a9248-a354-4c77-bf5b-9eed38f00219	6
2630753	ceFAZolin 3 GM Injection	PSN	4f3a9248-a354-4c77-bf5b-9eed38f00219	6
1665060	cefazolin 2000 MG Injection	SCD	4f3a9248-a354-4c77-bf5b-9eed38f00219	6
2630753	cefazolin 3000 MG Injection	SCD	4f3a9248-a354-4c77-bf5b-9eed38f00219	6
1665060	cefazolin (as cefazolin sodium) 2 GM Injection	SY	4f3a9248-a354-4c77-bf5b-9eed38f00219	6
2630753	cefazolin (as cefazolin sodium) 3 GM Injection	SY	4f3a9248-a354-4c77-bf5b-9eed38f00219	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
44567-845-01	44567084501	1 in 1 VIAL					Historical
44567-845-25	44567084525	25 VIAL in 1 CARTON (44567-845-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (44567-845-01)	25 vial	2024-05-10	No	No	Current