Application 065048

Type: ANDA
Sponsor: HIKMA FARMACEUTICA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFUROXIME SODIUM	CEFUROXIME SODIUM	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	EQ 750MG BASE/VIAL	No	No
002	CEFUROXIME SODIUM	CEFUROXIME SODIUM	INJECTABLE;INJECTION	EQ 1.5GM BASE/VIAL	No	No
003	CEFUROXIME	CEFUROXIME	Injectable; Injection	1.5G/20ML	No	No
004	CEFUROXIME	CEFUROXIME	Injectable; Injection	1.5G/100ML	No	No

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
A065048-001	CEFUROXIME SODIUM	CEFUROXIME SODIUM	EQ 750MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AB	RS	2004-01-09
A065048-002	CEFUROXIME SODIUM	CEFUROXIME SODIUM	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2004-01-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A065048-001	AB
A065048-002	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	A065048-001	CEFUROXIME SODIUM	EQ 750MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AB	RS	2004-01-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065048-002	CEFUROXIME SODIUM	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2004-01-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065048-001	CEFUROXIME SODIUM	EQ 750MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AB	RS	2004-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065048-002	CEFUROXIME SODIUM	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2004-01-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065048-001	CEFUROXIME SODIUM	EQ 750MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AB	RS	2004-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065048-002	CEFUROXIME SODIUM	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2004-01-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065048-001	CEFUROXIME SODIUM	EQ 750MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AB	RS	2004-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065048-002	CEFUROXIME SODIUM	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2004-01-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065048-001	CEFUROXIME SODIUM	EQ 750MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AB	RS	2004-01-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065048-002	CEFUROXIME SODIUM	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2004-01-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065048-001	CEFUROXIME SODIUM	EQ 750MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AB	RS	2004-01-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065048-002	CEFUROXIME SODIUM	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2004-01-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065048-001	CEFUROXIME SODIUM	EQ 750MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AB	RS	2004-01-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065048-002	CEFUROXIME SODIUM	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2004-01-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065048-001	CEFUROXIME SODIUM	EQ 750MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AB	RS	2004-01-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065048-002	CEFUROXIME SODIUM	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2004-01-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065048-001	CEFUROXIME SODIUM	EQ 750MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AB	RS	2004-01-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065048-002	CEFUROXIME SODIUM	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2004-01-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065048-001	CEFUROXIME SODIUM	EQ 750MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AB	RS	2004-01-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065048-002	CEFUROXIME SODIUM	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2004-01-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065048-001	CEFUROXIME SODIUM	EQ 750MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AB	RS	2004-01-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065048-002	CEFUROXIME SODIUM	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2004-01-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065048-001	CEFUROXIME SODIUM	EQ 750MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AB	RS	2004-01-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065048-002	CEFUROXIME SODIUM	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2004-01-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065048-001	CEFUROXIME SODIUM	EQ 750MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AB	RS	2004-01-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065048-002	CEFUROXIME SODIUM	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2004-01-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065048-001	CEFUROXIME SODIUM	EQ 750MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AB	RS	2004-01-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065048-002	CEFUROXIME SODIUM	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2004-01-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065048-001	CEFUROXIME SODIUM	EQ 750MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AB	RS	2004-01-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065048-002	CEFUROXIME SODIUM	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2004-01-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065048-001	CEFUROXIME SODIUM	EQ 750MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AB		2004-01-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065048-002	CEFUROXIME SODIUM	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2004-01-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065048-001	CEFUROXIME SODIUM	EQ 750MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AB		2004-01-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065048-002	CEFUROXIME SODIUM	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2004-01-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065048-001	CEFUROXIME SODIUM	EQ 750MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AB		2004-01-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065048-002	CEFUROXIME SODIUM	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2004-01-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065048-001	CEFUROXIME SODIUM	EQ 750MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AB		2004-01-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065048-002	CEFUROXIME SODIUM	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2004-01-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065048-001	CEFUROXIME SODIUM	EQ 750MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AB		2004-01-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065048-002	CEFUROXIME SODIUM	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2004-01-09	`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	A065048-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065048-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065048-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065048-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065048-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065048-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065048-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065048-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065048-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065048-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065048-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065048-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065048-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065048-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065048-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065048-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065048-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065048-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065048-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065048-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065048-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065048-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065048-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065048-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065048-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065048-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065048-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065048-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065048-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065048-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065048-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065048-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065048-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065048-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065048-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065048-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065048-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065048-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065048-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065048-002	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefuroxime	CEFUROXIME	Hikma Pharmaceuticals USA Inc.	703cc338-c0b6-4a02-b8db-c27aeff181df	2020-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065048 application number: ANDA065048 ndc (product): 0143-9977 ndc (product): 0143-9979
Cefuroxime	CEFUROXIME	Hikma Pharmaceuticals USA Inc.	19902965-d2d6-433f-982d-0095014df4e8	2018-09-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065048 application number: ANDA065048 ndc (product): 0143-9567 ndc (product): 0143-9568

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9567	Cefuroxime	Cefuroxime	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9567	Cefuroxime	Cefuroxime	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9568	Cefuroxime	Cefuroxime	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9568	Cefuroxime	Cefuroxime	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9977	Cefuroxime	Cefuroxime	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9977	Cefuroxime	Cefuroxime	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9977	Cefuroxime	Cefuroxime	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9979	Cefuroxime	Cefuroxime	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9979	Cefuroxime	Cefuroxime	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9979	Cefuroxime	Cefuroxime	Hikma Pharmaceuticals USA Inc.	ANDA	Current