Cefazolin

Product NDC: 25021-102
Requested package NDC: 25021-102-99
11-digit product format: 250210102
Labeler code: 25021
Product ID: 25021-102_76e20ece-6f09-4938-9732-3f4776848651
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cefazolin sodium
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Sagent Pharmaceuticals
Application: ANDA065306
Marketing category: ANDA
Marketing start: 2015-07-01
Marketing end: 2024-03-31
Substance: CEFAZOLIN SODIUM
Active strength: 10 g/1
Pharmacologic classes: Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag: No
Listing certified through: 0000-00-00
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	25021-102	25021-102-99	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
A065306-001	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22
A065306-002	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		RS	2014-08-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065306-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065306-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065306-002	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		RS	2014-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065306-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065306-002	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		RS	2014-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065306-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065306-002	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		RS	2014-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065306-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065306-002	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		RS	2014-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065306-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065306-002	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		RS	2014-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065306-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065306-002	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		RS	2014-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065306-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065306-002	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		RS	2014-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065306-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065306-002	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		RS	2014-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065306-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065306-002	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		RS	2014-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065306-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065306-002	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		RS	2014-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065306-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065306-002	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		RS	2014-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065306-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065306-002	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		RS	2014-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065306-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065306-002	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		RS	2014-08-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065306-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065306-002	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		RS	2014-08-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065306-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065306-002	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		RS	2014-08-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065306-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065306-002	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		RS	2014-08-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065306-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065306-002	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		RS	2014-08-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065306-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065306-002	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		RS	2014-08-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065306-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065306-002	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		RS	2014-08-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065306-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-10-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065306-002	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE / INJECTION		RS	2014-08-18	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A065306-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065306-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065306-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065306-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065306-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065306-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065306-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065306-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065306-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065306-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065306-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065306-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065306-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065306-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065306-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065306-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065306-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065306-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065306-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065306-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065306-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065306-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065306-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065306-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065306-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065306-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065306-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065306-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065306-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065306-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065306-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065306-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065306-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065306-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065306-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065306-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065306-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065306-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065306-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065306-001	AP	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
25021-102-69	EA - Each	25021-102	0c1464e0-5510-48f9-a399-d508a49f1908	1	2015-07-20
25021-102-99	EA - Each	25021-102	a62561f3-32af-42e5-be5d-d7f1314c2695	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, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]	10
cefazolin	ACTIVE MOIETY	IHS69L0Y4T	CEFAZOLIN (CEFAZOLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]	10
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
25021-102	CEFAZOLIN (CEFAZOLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]	14	Legacy NDC	20200611_48656c70-206d-652c-204f-62692d57616e.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefazolin	CEFAZOLIN	WG Critical Care, LLC	1999084a-124c-45f9-801f-416a1b942c96	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065306 application number: ANDA065306
Cefazolin	CEFAZOLIN SODIUM	Fresenius Kabi USA, LLC	47a8928f-708d-418a-829b-36eded96bac0	2020-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065306 application number: ANDA065306

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
25021-102-99	25021010299	10 BOTTLE in 1 CARTON (25021-102-99) > 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE	10 bottle	2009-04-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cefazolin for Injection, USP	Sagent Pharmaceuticals	2022-12-06	HUMAN PRESCRIPTION DRUG LABEL	7
Cefazolin for Injection, USP	Sagent Pharmaceuticals	2020-06-09	HUMAN PRESCRIPTION DRUG LABEL	14