Application 062831

Type: ANDA
Sponsor: SANDOZ

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	No
002	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	No	No
003	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	INJECTABLE;INJECTION	EQ 10GM BASE/VIAL	No	No

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
A062831-001	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	1988-12-09
A062831-002	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	1988-12-09
A062831-003	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	1992-09-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A062831-001	AP
A062831-002	AP
A062831-003	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 4 · 126 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	A062831-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	1988-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062831-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	1988-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062831-003	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	1992-09-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062831-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	1988-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062831-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	1988-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062831-003	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	1992-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062831-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	1988-12-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062831-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	1988-12-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062831-003	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	1992-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062831-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	1988-12-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062831-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	1988-12-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062831-003	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	1992-09-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062831-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	1988-12-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062831-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	1988-12-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062831-003	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	1992-09-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062831-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	1988-12-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062831-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	1988-12-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062831-003	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	1992-09-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062831-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	1988-12-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062831-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	1988-12-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062831-003	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	1992-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062831-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	1988-12-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062831-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	1988-12-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062831-003	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	1992-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062831-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	1988-12-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062831-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	1988-12-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062831-003	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	1992-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062831-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	1988-12-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062831-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	1988-12-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062831-003	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	1992-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062831-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	1988-12-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062831-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	1988-12-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062831-003	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	1992-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062831-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	1988-12-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062831-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	1988-12-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062831-003	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	1992-09-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062831-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	1988-12-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062831-002	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	1988-12-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062831-003	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	1992-09-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062831-001	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	1988-12-09	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A062831-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062831-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062831-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062831-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062831-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062831-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062831-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062831-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062831-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062831-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062831-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062831-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062831-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062831-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062831-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062831-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062831-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062831-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062831-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062831-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062831-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062831-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062831-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062831-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062831-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062831-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062831-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062831-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062831-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062831-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062831-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062831-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062831-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062831-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062831-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062831-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062831-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062831-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062831-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062831-001	AP	1	`1e350fbaab3a…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefazolin	CEFAZOLIN	Sandoz Inc	18e7366a-1b3e-4010-8f4a-dd559d4f2146	2025-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062831 application number: ANDA062831 ndc (product): 0781-3451 ndc (product): 0781-3450
Cefazolin	CEFAZOLIN	Sandoz Inc	e58f87fb-a47d-4081-a454-e4e916e2f629	2020-09-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062831 application number: ANDA062831 ndc (product): 0781-3452

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-3450	Cefazolin	Cefazolin	Sandoz Inc	ANDA	Current
0781-3450	Cefazolin	Cefazolin	Sandoz Inc	ANDA	Current
0781-3450	Cefazolin	Cefazolin	Sandoz Inc	ANDA	Current
0781-3450	Cefazolin	Cefazolin	Sandoz Inc	ANDA	Current
0781-3450	Cefazolin	Cefazolin	Sandoz Inc	ANDA	Current
0781-3451	Cefazolin	Cefazolin	Sandoz Inc	ANDA	Current
0781-3451	Cefazolin	Cefazolin	Sandoz Inc	ANDA	Current
0781-3451	Cefazolin	Cefazolin	Sandoz Inc	ANDA	Current
0781-3451	Cefazolin	Cefazolin	Sandoz Inc	ANDA	Current
0781-3451	Cefazolin	Cefazolin	Sandoz Inc	ANDA	Current
0781-3452	Cefazolin	Cefazolin	Sandoz Inc	ANDA	Current
0781-3452	Cefazolin	Cefazolin	Sandoz Inc	ANDA	Current
0781-3452	Cefazolin	Cefazolin	Sandoz Inc	ANDA	Current
0781-3452	Cefazolin	Cefazolin	Sandoz Inc	ANDA	Current
0781-3452	Cefazolin	Cefazolin	Sandoz Inc	ANDA	Current
0781-9338	Cefazolin	Cefazolin	Sandoz Inc	ANDA	Current
52584-024	Cefazolin	Cefazolin	General Injectables & Vaccines, Inc	ANDA	Current
55154-5439	Cefazolin	Cefazolin	Cardinal Health	ANDA	Current