CEFAZOLIN

Product NDC: 52584-087
Requested package NDC: 52584-087-00
11-digit product format: 525840087
Labeler code: 52584
Product ID: 52584-087_3104e1a1-525e-4f0b-b406-39c633f5b795
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cefazolin
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: General Injectables & Vaccines, Inc.
Application: ANDA203661
Marketing category: ANDA
Marketing start: 2019-05-06
Marketing end: 2024-03-31
Substance: CEFAZOLIN SODIUM
Active strength: 1 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	52584-087	52584-087-00	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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A203661-001	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28
A203661-002	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2022-03-11
A203661-003	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	INJECTABLE / INJECTION		2024-01-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203661-001	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 · 91 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	A203661-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203661-002	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2022-03-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203661-003	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	INJECTABLE / INJECTION		2024-01-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203661-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203661-002	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2022-03-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203661-003	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	INJECTABLE / INJECTION		2024-01-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203661-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203661-002	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2022-03-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203661-003	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	INJECTABLE / INJECTION		2024-01-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203661-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203661-002	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2022-03-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203661-003	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	INJECTABLE / INJECTION		2024-01-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203661-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203661-002	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2022-03-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203661-003	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	INJECTABLE / INJECTION		2024-01-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203661-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203661-002	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2022-03-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203661-003	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	INJECTABLE / INJECTION		2024-01-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203661-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203661-002	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2022-03-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203661-003	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	INJECTABLE / INJECTION		2024-01-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203661-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203661-002	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2022-03-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203661-003	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	INJECTABLE / INJECTION		2024-01-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203661-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203661-002	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2022-03-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203661-003	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	INJECTABLE / INJECTION		2024-01-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203661-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203661-002	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2022-03-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203661-003	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	INJECTABLE / INJECTION		2024-01-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203661-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203661-002	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2022-03-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203661-003	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	INJECTABLE / INJECTION		2024-01-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203661-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203661-002	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2022-03-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203661-003	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	INJECTABLE / INJECTION		2024-01-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203661-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203661-002	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2022-03-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203661-003	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	INJECTABLE / INJECTION		2024-01-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203661-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A203661-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203661-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203661-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203661-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203661-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203661-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203661-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203661-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203661-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203661-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203661-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203661-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203661-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203661-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203661-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203661-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203661-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203661-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203661-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203661-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203661-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203661-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203661-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203661-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203661-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203661-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203661-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203661-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203661-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203661-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203661-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203661-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203661-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203661-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203661-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203661-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203661-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203661-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203661-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203661-001	AP	1	`e64feba35796…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CEFAZOLIN	CEFAZOLIN	Henry Schein, Inc.	5a8c4bb2-a75e-4d7d-91fb-9a95f04fc94b	2025-10-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203661 application number: ANDA203661
Cefazolin	CEFAZOLIN	ProPharma Distribution	3d5cc73c-8a41-b285-e063-6294a90a609f	2025-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203661 application number: ANDA203661
Cefazolin	CEFAZOLIN	Apotex Corp.	0422fe47-c372-494f-bac2-612f550b44a4	2025-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203661 application number: ANDA203661
Cefazolin Sodium	CEFAZOLIN SODIUM	Direct_rx	22dfc2e4-07a7-8d13-e063-6394a90a3e9f	2024-09-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203661 application number: ANDA203661
Cefazolin	CEFAZOLIN	Qilu Pharmaceutical Co., Ltd.	e8bd9e95-8af5-416b-b58c-e1dbe3d052ac	2023-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203661 application number: ANDA203661
Cefazolin	CEFAZOLIN	Apotex Corp.	37a626aa-96dc-4c4d-bfbc-be4f328f918b	2023-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203661 application number: ANDA203661
Cefazolin	CEFAZOLIN	Medical Purchasing Solutions, LLC	79787707-c84f-f229-e053-2a91aa0a1f16	2023-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203661 application number: ANDA203661
Cefazolin	CEFAZOLIN	Proficient Rx LP	d24529e3-e2b4-46d6-81ba-b7da74501792	2022-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203661 application number: ANDA203661

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	Marketing start	Marketing end	Sample	Exclude flag	Status
52584-087-00	52584008700	1 VIAL, SINGLE-DOSE in 1 BAG (52584-087-00) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE	2019-05-06	2024-03-31	No	No	Current