CEFAZOLIN

Product NDC: 0404-9834
11-digit product format: 004049834
Labeler code: 0404
Product ID: 0404-9834_5c5cb92a-87b7-42e7-999c-d09323bfa0c3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cefazolin
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Henry Schein, Inc.
Application: ANDA065047
Marketing category: ANDA
Marketing start: 2022-01-09
Substance: CEFAZOLIN SODIUM
Active strength: 330 mg/mL
Pharmacologic classes: Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
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
A065047-001	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2001-09-18
A065047-002	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2001-09-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065047-001	AP
A065047-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A065047-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2001-09-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065047-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2001-09-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065047-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2001-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065047-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2001-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065047-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2001-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065047-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2001-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065047-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2001-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065047-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2001-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065047-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2001-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065047-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2001-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065047-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2001-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065047-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2001-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065047-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2001-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065047-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2001-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065047-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2001-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065047-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2001-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065047-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2001-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065047-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2001-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065047-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2001-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065047-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2001-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065047-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2001-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065047-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2001-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065047-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2001-09-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065047-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2001-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065047-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2001-09-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065047-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2001-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065047-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2001-09-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065047-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2001-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065047-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2001-09-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065047-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2001-09-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065047-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2001-09-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065047-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2001-09-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065047-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2001-09-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065047-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2001-09-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065047-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2001-09-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065047-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2001-09-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065047-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP		2001-09-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065047-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP		2001-09-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065047-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2001-09-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065047-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2001-09-18	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A065047-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065047-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065047-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065047-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065047-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065047-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065047-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065047-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065047-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065047-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065047-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065047-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065047-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065047-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065047-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065047-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065047-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065047-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065047-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065047-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065047-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065047-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065047-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065047-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065047-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065047-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065047-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065047-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065047-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065047-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065047-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065047-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065047-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065047-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065047-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065047-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065047-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065047-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065047-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065047-002	AP	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: CEFAZOLIN
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CEFAZOLIN SODIUM	330 mg/mL

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1665050	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
197d5702-2c20-480e-8246-4d0d21f871be	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
0404-9834-99	CEFAZOLIN	3 mL in 1 VIAL	INJECTION, POWDER, FOR SOLUTION	3		6
0404-9834-99	CEFAZOLIN	1 in 1 BAG	INJECTION, POWDER, FOR SOLUTION	1		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0404-9834	CEFAZOLIN INJECTION, POWDER, FOR SOLUTION [HENRY SCHEIN, INC.]	5	Current NDC, Legacy NDC, 2 package rows	20241018_197d5702-2c20-480e-8246-4d0d21f871be.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefazolin	CEFAZOLIN	Hikma Pharmaceuticals USA Inc.	26de1ce9-06a9-486f-b27d-2ac635f018d1	2026-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065047 application number: ANDA065047
Cefazolin	CEFAZOLIN	Civica, Inc.	9ea55207-6d86-401e-b9b9-73c9534a233f	2026-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065047 application number: ANDA065047
Cefazolin	CEFAZOLIN	Hikma Pharmaceuticals USA Inc.	1dc9de56-e259-4546-a1db-23119a8a088e	2026-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065047 application number: ANDA065047
CEFAZOLIN	CEFAZOLIN	Henry Schein, Inc.	197d5702-2c20-480e-8246-4d0d21f871be	2025-10-27	Warnings	Exact identifier application applno (ANDA): 065047 application number: ANDA065047 ndc (product): 0404-9834
CEFAZOLIN	CEFAZOLIN	Henry Schein Inc.	922fb1a1-ad4c-4a12-8d5d-00fe13af18e8	2025-10-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065047 application number: ANDA065047
Cefazolin	CEFAZOLIN	A-S Medication Solutions	8a772acc-726d-40e6-88ee-b6075cbf9b28	2023-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065047 application number: ANDA065047
Cefazolin	CEFAZOLIN	Medical Purchasing Solutions, LLC	6673be13-4c74-70b9-e053-2a91aa0a211d	2023-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065047 application number: ANDA065047

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
1665050	ceFAZolin 1 GM Injection	PSN	197d5702-2c20-480e-8246-4d0d21f871be	6
1665050	cefazolin 1000 MG Injection	SCD	197d5702-2c20-480e-8246-4d0d21f871be	6
1665050	cefazolin 1 GM (as cefazolin sodium) Injection	SY	197d5702-2c20-480e-8246-4d0d21f871be	6
1665050	cefazolin 1 GM Injection	SY	197d5702-2c20-480e-8246-4d0d21f871be	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0404-9834-99	00404983499	1 VIAL in 1 BAG (0404-9834-99) / 3 mL in 1 VIAL	1 vial	2022-01-09	0000-00-00	No	No	Current