Cefazolin

Product NDC: 68258-8978
11-digit product format: 682588978
Labeler code: 68258
Product ID: 68258-8978_d9c34849-a809-4a5c-884d-b877006a7e3a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cefazolin sodium
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Dispensing Solutions, Inc.
Application: ANDA063207
Marketing category: ANDA
Marketing start: 2009-02-01
Marketing end: 0000-00-00
Substance: CEFAZOLIN SODIUM
Active strength: 1 g/3mL
Pharmacologic classes: Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
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	68258-8978		I	Inactivated by FDA		2026-10-16
excluded package	package	68258-8978	68258-8978-2	I	Inactivated by FDA		2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68258-8978-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68258-8978-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68258-8978-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68258-8978-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68258-8978-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68258-8978-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68258-8978-2	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68258-8978-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68258-8978-2	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68258-8978-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68258-8978-2	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68258-8978-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68258-8978-2	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68258-8978-2	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68258-8978-2	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68258-8978-2	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68258-8978-2	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68258-8978-2	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68258-8978-2	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68258-8978-2	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68258-8978-2	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	68258-8978-2	`110d247fa046…`	`a55b01930146…`

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
A063207-001	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION			1991-12-27

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	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A063207-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1991-12-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A063207-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1991-12-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A063207-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1991-12-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A063207-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1991-12-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A063207-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1991-12-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A063207-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1991-12-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A063207-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1991-12-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A063207-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1991-12-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A063207-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1991-12-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A063207-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1991-12-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A063207-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1991-12-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A063207-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1991-12-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A063207-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1991-12-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A063207-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1991-12-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A063207-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1991-12-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A063207-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1991-12-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A063207-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1991-12-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063207-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1991-12-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A063207-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1991-12-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A063207-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1991-12-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A063207-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1991-12-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A063207-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1991-12-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A063207-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1991-12-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A063207-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1991-12-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A063207-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1991-12-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A063207-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1991-12-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A063207-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1991-12-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A063207-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1991-12-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A063207-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1991-12-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A063207-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1991-12-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A063207-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1991-12-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A063207-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1991-12-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A063207-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1991-12-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A063207-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1991-12-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A063207-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1991-12-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A063207-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1991-12-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A063207-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1991-12-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A063207-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1991-12-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A063207-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1991-12-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A063207-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1991-12-27	`3a93d1ddd44b…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68258-8978-2	2019-11-13	C162847	48780-1	97449f38-c962-f6ea-e053-dbdaa90aa703	Cefazolin for Injection, USP For IM or IV Use

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68258-8978-2	Cefazolin	25 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	25		2
68258-8978-2	Cefazolin	3 mL in 1 VIAL	INJECTION, POWDER, FOR SOLUTION	3		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
cefazolin sodium	ACTIVE INGREDIENT	P380M0454Z	CEFAZOLIN (CEFAZOLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [DISPENSING SOLUTIONS, INC.]	2
cefazolin	ACTIVE MOIETY	IHS69L0Y4T	CEFAZOLIN (CEFAZOLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [DISPENSING SOLUTIONS, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68258-8978	CEFAZOLIN (CEFAZOLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [DISPENSING SOLUTIONS, INC.]	2	Legacy NDC, 2 package rows	20111004_e48fcd44-243f-4af0-ae45-47db4a8687b9.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	e48fcd44-243f-4af0-ae45-47db4a8687b9	2
1665050	cefazolin 1000 MG Injection	SCD	e48fcd44-243f-4af0-ae45-47db4a8687b9	2
1665050	cefazolin 1 GM (as cefazolin sodium) Injection	SY	e48fcd44-243f-4af0-ae45-47db4a8687b9	2
1665050	cefazolin 1 GM Injection	SY	e48fcd44-243f-4af0-ae45-47db4a8687b9	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68258-8978-2	68258897802	25 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cefazolin for Injection, USP For IM or IV Use	Dispensing Solutions, Inc.	2011-10-03	HUMAN PRESCRIPTION DRUG LABEL	2