Cefazolin

Product NDC: 0409-2585
11-digit product format: 004092585
Labeler code: 0409
Product ID: 0409-2585_24419190-91d0-4ec9-9ee6-478b5775af1d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefazolin
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Hospira, Inc
Application: ANDA065345
Marketing category: ANDA
Marketing start: 2007-05-09
Marketing end: 0000-00-00
Substance: CEFAZOLIN SODIUM
Active strength: 1 g/1
Pharmacologic classes: Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0409-2585		D	Discontinued by firm		2026-10-21
excluded package	package	0409-2585	0409-2585-01	D	Discontinued by firm		2026-10-21

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065345-001	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION			2007-05-09

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 2 · 44 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
2026-10-15 13:18:30	2026-09	A065345-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2007-05-09	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A065345-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2007-05-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065345-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2007-05-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065345-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2007-05-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065345-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2007-05-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065345-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2007-05-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065345-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2007-05-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065345-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2007-05-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065345-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2007-05-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065345-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2007-05-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065345-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2007-05-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065345-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2007-05-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065345-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2007-05-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065345-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2007-05-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065345-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2007-05-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065345-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2007-05-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065345-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2007-05-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065345-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2007-05-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065345-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2007-05-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065345-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2007-05-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065345-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2007-05-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065345-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2007-05-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065345-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2007-05-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065345-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2007-05-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065345-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2007-05-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065345-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2007-05-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065345-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2007-05-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065345-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2007-05-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065345-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2007-05-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065345-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2007-05-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065345-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2007-05-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065345-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2007-05-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065345-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2007-05-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065345-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2007-05-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065345-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2007-05-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065345-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2007-05-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065345-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2007-05-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065345-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2007-05-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065345-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2007-05-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065345-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2007-05-09	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A065345-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065345-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065345-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065345-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065345-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065345-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065345-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065345-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065345-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065345-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065345-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065345-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065345-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065345-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065345-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065345-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065345-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065345-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065345-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065345-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065345-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065345-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065345-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065345-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065345-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065345-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065345-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065345-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065345-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065345-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065345-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065345-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065345-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065345-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065345-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065345-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065345-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065345-001	AP	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
0409-2585-01	Cefazolin	25 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	25		18
0409-2585-11	Cefazolin	1 in 1 VIAL	INJECTION, POWDER, FOR SOLUTION	1		18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0409-2585-01	EA - Each	0409-2585	0aa71b70-ed0a-498a-a461-1393e4efcee2	1	2012-07-24
0409-2585-11	EA - Each	0409-2585	e4d224db-fb8f-44d1-941c-200bc607e827	1	2018-08-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
CEFAZOLIN SODIUM	ACTIVE INGREDIENT	P380M0454Z	CEFAZOLIN INJECTION, POWDER, FOR SOLUTION [HOSPIRA, INC]	13
CEFAZOLIN	ACTIVE MOIETY	IHS69L0Y4T	CEFAZOLIN INJECTION, POWDER, FOR SOLUTION [HOSPIRA, INC]	13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0409-2585	CEFAZOLIN INJECTION, POWDER, FOR SOLUTION [HOSPIRA, INC]	17	Legacy NDC, 2 package rows	20201104_62441488-fc97-4535-a249-4485fb075022.zip

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	62441488-fc97-4535-a249-4485fb075022	18
1665050	cefazolin 1000 MG Injection	SCD	62441488-fc97-4535-a249-4485fb075022	18
1665050	cefazolin 1 GM (as cefazolin sodium) Injection	SY	62441488-fc97-4535-a249-4485fb075022	18
1665050	cefazolin 1 GM Injection	SY	62441488-fc97-4535-a249-4485fb075022	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0409-2585-01	00409258501	25 VIAL in 1 CARTON (0409-2585-01) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0409-2585-11)	25 vial	2007-08-07	0000-00-00	No	No	Current
0409-2585-11	00409258511	1 in 1 VIAL						Historical