Cefazolin

Product NDC: 52584-100
Requested package NDC: 52584-100-10
11-digit product format: 525840100
Labeler code: 52584
Product ID: 52584-100_276f669a-f3b2-4e67-a91a-26e4ce7f131b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefazolin
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: General Injectables and Vaccines, Inc.
Application: ANDA065303
Marketing category: ANDA
Marketing start: 2017-02-15
Marketing end: 2022-03-31
Substance: CEFAZOLIN SODIUM
Active strength: 500 mg/2.2mL
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	52584-100	52584-100-10	D	Discontinued by firm		2026-08-17

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
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 · 84 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
2026-08-18 06:07:40	2026-07	A065303-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065303-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-10-22	`caaa826d4ba7…`
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…`

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	A065303-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065303-002	AP	1	`caaa826d4ba7…`
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…`

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
IHS69L0Y4T	CEFAZOLIN	25953-19-9	Cefazolin

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52584-100-10	52584010010	1 VIAL in 1 BAG (52584-100-10) > 2.2 mL in 1 VIAL	1 vial	2017-02-15	2022-03-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cefazolin for Injection, USP Rx only	General Injectables and Vaccines, Inc.	2020-03-30	HUMAN PRESCRIPTION DRUG LABEL	5