Cefazolin

Product NDC: 0338-3503
11-digit product format: 003383503
Labeler code: 0338
Product ID: 0338-3503_092b9ea3-0c78-4236-80c9-ff97d09fa14e
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: 2015-08-07
Substance: CEFAZOLIN SODIUM
Active strength: 1 g/50mL
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 · 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 · 95 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	N207131-001	CEFAZOLIN IN DEXTROSE	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-08-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207131-002	CEFAZOLIN IN DEXTROSE	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207131-003	CEFAZOLIN IN DEXTROSE	EQ 3GM BASE/150ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-05-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N207131-001	CEFAZOLIN IN DEXTROSE	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-08-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207131-002	CEFAZOLIN IN DEXTROSE	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207131-003	CEFAZOLIN IN DEXTROSE	EQ 3GM BASE/150ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-05-31	`caaa826d4ba7…`
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…`

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	1 g/50mL

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
0338-3503-41	Cefazolin	24 in 1 CARTON	INJECTION, SOLUTION	24		17
0338-3503-41	Cefazolin	50 mL in 1 BAG	INJECTION, SOLUTION	50		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0338-3503-41	ML - Milliliter	0338-3503	a6f49c5c-fe4a-49bd-9cfd-a9d233a1179a	1	2012-07-24

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]	9
CEFAZOLIN	ACTIVE MOIETY	IHS69L0Y4T	CEFAZOLIN (CEFAZOLIN SODIUM) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	9
DEXTROSE MONOHYDRATE	INACTIVE INGREDIENT	LX22YL083G	CEFAZOLIN (CEFAZOLIN SODIUM) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	9
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	CEFAZOLIN (CEFAZOLIN SODIUM) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	9
WATER	INACTIVE INGREDIENT	059QF0KO0R	CEFAZOLIN (CEFAZOLIN SODIUM) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	9
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
0338-3503	CEFAZOLIN (CEFAZOLIN SODIUM) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	15	Current NDC, Legacy NDC, 2 package rows	20250519_d91a8d13-99a0-4d87-88dc-71cbd37922b4.zip

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	Marketing end	Sample	Exclude flag	Status
0338-3503-41	00338350341	24 BAG in 1 CARTON (0338-3503-41) / 50 mL in 1 BAG	24 bag	2015-08-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cefazolin	Baxter Healthcare Corporation	2026-08-31	HUMAN PRESCRIPTION DRUG LABEL	18
Cefazolin Injection, USP in GALAXY Container (PL 2040 Plastic)	Baxter Healthcare Corporation	2018-05-23	HUMAN PRESCRIPTION DRUG LABEL	18