Application 050679

Type: NDA
Sponsor: HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MAXIPIME	CEFEPIME HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	Yes	Yes
002	MAXIPIME	CEFEPIME HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	Yes	Yes
003	MAXIPIME	CEFEPIME HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	RLD / RS	Approval date
N050679-001	MAXIPIME	CEFEPIME HYDROCHLORIDE	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-01-18
N050679-002	MAXIPIME	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-01-18
N050679-003	MAXIPIME	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-01-18

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N050679-001	MAXIPIME	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-01-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050679-002	MAXIPIME	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-01-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050679-003	MAXIPIME	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-01-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050679-001	MAXIPIME	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050679-002	MAXIPIME	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050679-003	MAXIPIME	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-01-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050679-001	MAXIPIME	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050679-002	MAXIPIME	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050679-003	MAXIPIME	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-01-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050679-001	MAXIPIME	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050679-002	MAXIPIME	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050679-003	MAXIPIME	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-01-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050679-001	MAXIPIME	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050679-002	MAXIPIME	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050679-003	MAXIPIME	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-01-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050679-001	MAXIPIME	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050679-002	MAXIPIME	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050679-003	MAXIPIME	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-01-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050679-001	MAXIPIME	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-01-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050679-002	MAXIPIME	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-01-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050679-003	MAXIPIME	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-01-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050679-001	MAXIPIME	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-01-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050679-002	MAXIPIME	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-01-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050679-003	MAXIPIME	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-01-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050679-001	MAXIPIME	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-01-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050679-002	MAXIPIME	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-01-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050679-003	MAXIPIME	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-01-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050679-001	MAXIPIME	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-01-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050679-002	MAXIPIME	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-01-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050679-003	MAXIPIME	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-01-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050679-001	MAXIPIME	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-01-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050679-002	MAXIPIME	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-01-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050679-003	MAXIPIME	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-01-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050679-001	MAXIPIME	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-01-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050679-002	MAXIPIME	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-01-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050679-003	MAXIPIME	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-01-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050679-001	MAXIPIME	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	RLD	1996-01-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050679-002	MAXIPIME	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD	1996-01-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050679-003	MAXIPIME	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	RLD	1996-01-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050679-001	MAXIPIME	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	RLD	1996-01-18	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-12-20 04:57 UTC	2023-12	N050679-002	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N050679-003	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050679-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050679-002	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050679-003	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050679-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050679-002	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050679-003	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050679-001	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050679-002	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050679-003	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050679-001	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050679-002	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050679-003	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050679-001	AP	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N050679-002	AP	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N050679-003	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050679-001	AP	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N050679-002	AP	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N050679-003	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050679-001	AP	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050679-002	AP	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050679-003	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050679-001	AP	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N050679-002	AP	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N050679-003	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050679-001	AP	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N050679-002	AP	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N050679-003	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050679-001	AP	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050679-002	AP	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050679-003	AP	1	`cb3db0bc1861…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CEFEPIME HYDROCHLORIDE AND DEXTROSE	CEFEPIME HYDROCHLORIDE	B. Braun Medical Inc.	57517a0e-ec1b-4605-a7cc-7e3801158ec9	2026-04-07	Warnings, Adverse reactions	Name fallback generic name: CEFEPIME HYDROCHLORIDE
Cefepime Hydrochloride	CEFEPIME HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	b9914e7e-13f6-42d4-9cbb-8c7ed1ce7a01	2025-10-14	Warnings, Adverse reactions	Name fallback generic name: CEFEPIME HYDROCHLORIDE
Cefepime Hydrochloride	CEFEPIME HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	f64c181e-28c5-48ab-aa67-5ca0e3fd079c	2025-06-30	Warnings, Adverse reactions	Name fallback generic name: CEFEPIME HYDROCHLORIDE
Cefepime	CEFEPIME HYDROCHLORIDE	Qilu Pharmaceutical Co., Ltd.	80b4c811-4a71-47fb-8565-85ce9d0f782c	2021-11-15	Warnings, Adverse reactions	Name fallback generic name: CEFEPIME HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
0409-0217	MAXIPIME	Cefepime	Hospira, Inc.	NDA	Current
0409-0217	MAXIPIME	Cefepime	Hospira, Inc.	NDA	Current
0409-0217	MAXIPIME	Cefepime	Hospira, Inc.	NDA	Current
0409-0218	MAXIPIME	Cefepime	Hospira, Inc.	NDA	Current
0409-0218	MAXIPIME	Cefepime	Hospira, Inc.	NDA	Current
0409-0219	MAXIPIME	Cefepime	Hospira, Inc.	NDA	Current
0409-0219	MAXIPIME	Cefepime	Hospira, Inc.	NDA	Current
0409-0220	MAXIPIME	Cefepime	Hospira, Inc.	NDA	Current
0409-0220	MAXIPIME	Cefepime	Hospira, Inc.	NDA	Current
0409-0220	MAXIPIME	Cefepime	Hospira, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68356	SUPPL	2021-08-12
68349	SUPPL	2021-08-12
48290	SUPPL	2017-05-09
48243	SUPPL	2017-05-05
39102	SUPPL	2016-03-03
7983	SUPPL	2016-03-03
30263	SUPPL	2014-05-06
39099	SUPPL	2014-05-02
39101	SUPPL	2013-03-19
30264	SUPPL	2013-03-18
18006	SUPPL	2012-09-11
7982	SUPPL	2012-09-10
7981	SUPPL	2009-11-20
39100	SUPPL	2009-09-30
44202	ORIG	2007-12-17
30262	SUPPL	2007-11-26
39098	SUPPL	2007-09-19
18005	SUPPL	2004-06-10
7980	SUPPL	2004-06-10
39097	SUPPL	2003-03-26
7979	SUPPL	2003-03-26
30261	SUPPL	2002-08-21
7978	SUPPL	2002-08-21
7977	SUPPL	2002-08-21
42673	SUPPL	2001-07-18
39096	SUPPL	1999-01-27
7976	SUPPL	1999-01-27
22181	SUPPL	1997-05-16
57440	ORIG	1996-01-18