Cefazolin

Product NDC: 0338-0096
11-digit product format: 003380096
Labeler code: 0338
Product ID: 0338-0096_9139fd65-24ba-42a9-a084-9d6dd2d1b181
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefazolin Sodium
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Baxter Healthcare Corporation
Application: NDA207131
Marketing category: NDA
Marketing start: 2024-05-31
Substance: CEFAZOLIN SODIUM
Active strength: 3 g/150mL
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 1.

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
N207131-001	CEFAZOLIN IN DEXTROSE	CEFAZOLIN SODIUM	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-08-07
N207131-002	CEFAZOLIN IN DEXTROSE	CEFAZOLIN SODIUM	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-01
N207131-003	CEFAZOLIN IN DEXTROSE	CEFAZOLIN SODIUM	EQ 3GM BASE/150ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-05-31

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 3 · 89 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	N207131-001	CEFAZOLIN IN DEXTROSE	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207131-002	CEFAZOLIN IN DEXTROSE	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207131-003	CEFAZOLIN IN DEXTROSE	EQ 3GM BASE/150ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207131-001	CEFAZOLIN IN DEXTROSE	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207131-002	CEFAZOLIN IN DEXTROSE	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207131-003	CEFAZOLIN IN DEXTROSE	EQ 3GM BASE/150ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207131-001	CEFAZOLIN IN DEXTROSE	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-08-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207131-002	CEFAZOLIN IN DEXTROSE	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207131-003	CEFAZOLIN IN DEXTROSE	EQ 3GM BASE/150ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207131-001	CEFAZOLIN IN DEXTROSE	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-08-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207131-002	CEFAZOLIN IN DEXTROSE	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207131-003	CEFAZOLIN IN DEXTROSE	EQ 3GM BASE/150ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207131-001	CEFAZOLIN IN DEXTROSE	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-08-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207131-002	CEFAZOLIN IN DEXTROSE	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207131-003	CEFAZOLIN IN DEXTROSE	EQ 3GM BASE/150ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207131-001	CEFAZOLIN IN DEXTROSE	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-08-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207131-002	CEFAZOLIN IN DEXTROSE	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207131-003	CEFAZOLIN IN DEXTROSE	EQ 3GM BASE/150ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207131-001	CEFAZOLIN IN DEXTROSE	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-08-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207131-002	CEFAZOLIN IN DEXTROSE	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207131-003	CEFAZOLIN IN DEXTROSE	EQ 3GM BASE/150ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-05-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207131-001	CEFAZOLIN IN DEXTROSE	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-08-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207131-002	CEFAZOLIN IN DEXTROSE	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207131-003	CEFAZOLIN IN DEXTROSE	EQ 3GM BASE/150ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207131-001	CEFAZOLIN IN DEXTROSE	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-08-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207131-002	CEFAZOLIN IN DEXTROSE	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207131-003	CEFAZOLIN IN DEXTROSE	EQ 3GM BASE/150ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207131-001	CEFAZOLIN IN DEXTROSE	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-08-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207131-002	CEFAZOLIN IN DEXTROSE	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207131-003	CEFAZOLIN IN DEXTROSE	EQ 3GM BASE/150ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-05-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207131-001	CEFAZOLIN IN DEXTROSE	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-08-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207131-002	CEFAZOLIN IN DEXTROSE	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207131-003	CEFAZOLIN IN DEXTROSE	EQ 3GM BASE/150ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-05-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207131-001	CEFAZOLIN IN DEXTROSE	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-08-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207131-002	CEFAZOLIN IN DEXTROSE	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207131-003	CEFAZOLIN IN DEXTROSE	EQ 3GM BASE/150ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-05-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207131-001	CEFAZOLIN IN DEXTROSE	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-08-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207131-002	CEFAZOLIN IN DEXTROSE	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207131-003	CEFAZOLIN IN DEXTROSE	EQ 3GM BASE/150ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-05-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207131-001	CEFAZOLIN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-08-07	`8072bd15b7f6…`

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/150mL

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1665050	Internal RxNorm lookup
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
d91a8d13-99a0-4d87-88dc-71cbd37922b4	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
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
6e62eeca-6666-f31f-9873-48ea9ede8354	Product name	2	20190214
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
afa25392-d76e-4453-8841-fde3a34824f1	Product name	2	20160309
53cae805-773b-4bc5-a836-3e22e250892e	Product name	1	20150922
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
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
0338-0096-06	Cefazolin	6 in 1 CARTON	INJECTION, SOLUTION	6		17
0338-0096-06	Cefazolin	150 mL in 1 BAG	INJECTION, SOLUTION	150		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0338-0096-06	ML - Milliliter	0338-0096	abe0a2e3-d8df-46bc-9946-2d77475f4864	1	2024-10-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CEFAZOLIN SODIUM	ACTIVE INGREDIENT	P380M0454Z	CEFAZOLIN (CEFAZOLIN SODIUM) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
CEFAZOLIN	ACTIVE MOIETY	IHS69L0Y4T	CEFAZOLIN (CEFAZOLIN SODIUM) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
DEXTROSE MONOHYDRATE	INACTIVE INGREDIENT	LX22YL083G	CEFAZOLIN (CEFAZOLIN SODIUM) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	CEFAZOLIN (CEFAZOLIN SODIUM) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	CEFAZOLIN (CEFAZOLIN SODIUM) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0338-0096	CEFAZOLIN (CEFAZOLIN SODIUM) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	15	Current NDC, 2 package rows	20250519_d91a8d13-99a0-4d87-88dc-71cbd37922b4.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 SODIUM	Baxter Healthcare Corporation	d91a8d13-99a0-4d87-88dc-71cbd37922b4	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 207131 application number: NDA207131 ndc (product): 0338-0096

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
P380M0454Z	CEFAZOLIN SODIUM	27164-46-1	CEFAZOLIN SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1665050	ceFAZolin 1 GM Injection	PSN	d91a8d13-99a0-4d87-88dc-71cbd37922b4	17
1665060	ceFAZolin 2 GM Injection	PSN	d91a8d13-99a0-4d87-88dc-71cbd37922b4	17
2630753	ceFAZolin 3 GM Injection	PSN	d91a8d13-99a0-4d87-88dc-71cbd37922b4	17
1665050	cefazolin 1000 MG Injection	SCD	d91a8d13-99a0-4d87-88dc-71cbd37922b4	17
1665060	cefazolin 2000 MG Injection	SCD	d91a8d13-99a0-4d87-88dc-71cbd37922b4	17
2630753	cefazolin 3000 MG Injection	SCD	d91a8d13-99a0-4d87-88dc-71cbd37922b4	17
1665060	cefazolin (as cefazolin sodium) 2 GM Injection	SY	d91a8d13-99a0-4d87-88dc-71cbd37922b4	17
2630753	cefazolin (as cefazolin sodium) 3 GM Injection	SY	d91a8d13-99a0-4d87-88dc-71cbd37922b4	17
1665050	cefazolin 1 GM (as cefazolin sodium) Injection	SY	d91a8d13-99a0-4d87-88dc-71cbd37922b4	17
1665050	cefazolin 1 GM Injection	SY	d91a8d13-99a0-4d87-88dc-71cbd37922b4	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0338-0096-06	00338009606	6 BAG in 1 CARTON (0338-0096-06) / 150 mL in 1 BAG	6 bag	2024-05-31	No	No	Current