Application 065047

Type: ANDA
Sponsor: HIKMA FARMACEUTICA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	No	Yes
002	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	No	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…`

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 ndc (product): 0143-9262
Cefazolin	CEFAZOLIN	Civica, Inc.	9ea55207-6d86-401e-b9b9-73c9534a233f	2026-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065047 application number: ANDA065047 ndc (product): 72572-055
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 ndc (product): 0143-9923 ndc (product): 0143-9924
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 ndc (product): 0404-9835
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 ndc (product): 50090-4256
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 ndc (product): 71872-7027

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9262	Cefazolin	Cefazolin	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9262	Cefazolin	Cefazolin	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9923	Cefazolin	Cefazolin	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9923	Cefazolin	Cefazolin	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9924	Cefazolin	Cefazolin	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9924	Cefazolin	Cefazolin	West-Ward Pharmaceuticals Corp	ANDA	Current
0404-9834	CEFAZOLIN	cefazolin	Henry Schein, Inc.	ANDA	Current
0404-9834	CEFAZOLIN	cefazolin	Henry Schein, Inc.	ANDA	Current
0404-9834	CEFAZOLIN	cefazolin	Henry Schein, Inc.	ANDA	Current
0404-9834	CEFAZOLIN	cefazolin	Henry Schein, Inc.	ANDA	Current
0404-9835	CEFAZOLIN	cefazolin	Henry Schein Inc.	ANDA	Current
0404-9835	CEFAZOLIN	cefazolin	Henry Schein Inc.	ANDA	Current
0404-9835	CEFAZOLIN	cefazolin	Henry Schein Inc.	ANDA	Current
50090-4256	Cefazolin	Cefazolin	A-S Medication Solutions	ANDA	Current
52584-923	CEFAZOLIN	cefazolin	General Injectables & Vaccines, Inc.	ANDA	Current
52584-923	CEFAZOLIN	cefazolin	General Injectables & Vaccines, Inc.	ANDA	Current
52584-923	CEFAZOLIN	cefazolin	General Injectables & Vaccines, Inc.	ANDA	Current
52584-924	CEFAZOLIN	cefazolin	General Injectables and Vaccines, Inc.	ANDA	Current
52584-924	CEFAZOLIN	cefazolin	General Injectables and Vaccines, Inc.	ANDA	Current
52584-924	CEFAZOLIN	cefazolin	General Injectables and Vaccines, Inc.	ANDA	Current
55154-7463	Cefazolin	Cefazolin	Cardinal Health	ANDA	Current
71872-7027	Cefazolin	Cefazolin	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7027	Cefazolin	Cefazolin	Medical Purchasing Solutions, LLC	ANDA	Current
72572-055	Cefazolin	Cefazolin	Civica, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22306	ORIG	2004-12-08
30635	ORIG	2003-04-10