cefazolin

Product NDC: 25021-100
Requested package NDC: 25021-100-10
11-digit product format: 250210100
Labeler code: 25021
Product ID: 25021-100_6dfa594e-90e8-4085-af30-6d3660a6bebf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cefazolin sodium
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Sagent Pharmaceuticals
Application: ANDA065303
Marketing category: ANDA
Marketing start: 2009-02-01
Marketing end: 0000-00-00
Substance: CEFAZOLIN SODIUM
Active strength: 500 mg/2.2mL
Pharmacologic classes: Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	25021-100	25021-100-10	D	Discontinued by firm		2026-08-03

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
A065303-001	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22
A065303-002	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A065303-001	AP
A065303-002	AP

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065303-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065303-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065303-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065303-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065303-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065303-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065303-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065303-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065303-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065303-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065303-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065303-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065303-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065303-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065303-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065303-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065303-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065303-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065303-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065303-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065303-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065303-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065303-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065303-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065303-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065303-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065303-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065303-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065303-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065303-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065303-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065303-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065303-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065303-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065303-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065303-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065303-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065303-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065303-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065303-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065303-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065303-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065303-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065303-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065303-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065303-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065303-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065303-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065303-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065303-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065303-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065303-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065303-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065303-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065303-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065303-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065303-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065303-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065303-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065303-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065303-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065303-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065303-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065303-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065303-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065303-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065303-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065303-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065303-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065303-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065303-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065303-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065303-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065303-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065303-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065303-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065303-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065303-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065303-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065303-002	AP	1	`782e0a99824c…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
25021-100-10	EA - Each	25021-100	bf5930ee-e2b1-48ae-bee7-b4720f8ad045	1	2012-07-24
25021-100-66	EA - Each	25021-100	3f29c7cf-2754-45b1-86dd-66567b287188	1	2015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
cefazolin sodium	ACTIVE INGREDIENT	P380M0454Z	CEFAZOLIN (CEFAZOLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]	7
cefazolin	ACTIVE MOIETY	IHS69L0Y4T	CEFAZOLIN (CEFAZOLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]	7
Cefazolin Sodium	ACTIVE INGREDIENT	P380M0454Z	CEFAZOLIN (CEFAZOLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]	2
cefazolin	ACTIVE MOIETY	IHS69L0Y4T	CEFAZOLIN (CEFAZOLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
25021-100	CEFAZOLIN (CEFAZOLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]	14	Legacy NDC	20240302_e8f40f72-3cf0-43dc-a797-fb98dd8af228.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefazolin	CEFAZOLIN	WG Critical Care, LLC	00dd6da7-50a8-44c9-b2dc-7948973df392	2026-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065303 application number: ANDA065303
Cefazolin	CEFAZOLIN	WG Critical Care, LLC	f17160d4-fc42-4f9c-abb8-d04f01ae6dd1	2025-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065303 application number: ANDA065303
CEFAZOLIN	CEFAZOLIN SODIUM	Fresenius Kabi USA, LLC	c47c8d14-1eef-40f9-9d11-f0c300b1d4be	2023-09-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065303 application number: ANDA065303

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
25021-100-10	25021010010	25 VIAL in 1 CARTON (25021-100-10) > 2.2 mL in 1 VIAL	25 vial	2009-02-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cefazolin for Injection, USP	Sagent Pharmaceuticals	2025-10-26	HUMAN PRESCRIPTION DRUG LABEL	15
Cefazolin for Injection, USP	Sagent Pharmaceuticals	2022-12-07	HUMAN PRESCRIPTION DRUG LABEL	9
Cefazolin for Injection, USP Rx only	General Injectables and Vaccines, Inc.	2020-03-30	HUMAN PRESCRIPTION DRUG LABEL	5