Cefepime

Product NDC: 44567-130
11-digit product format: 445670130
Labeler code: 44567
Product ID: 44567-130_5a8ec08f-ddc8-4ce9-9ef4-4d97a9188f9f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefepime
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: WG Critical Care, LLC
Application: ANDA065441
Marketing category: ANDA
Marketing start: 2021-03-31
Substance: CEFEPIME HYDROCHLORIDE
Active strength: 1 g/20mL
Pharmacologic classes: Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: 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
A065441-001	CEFEPIME HYDROCHLORIDE	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-03-20
A065441-002	CEFEPIME HYDROCHLORIDE	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP		2008-03-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065441-001	AP
A065441-002	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A065441-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065441-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065441-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065441-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065441-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065441-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065441-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065441-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065441-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065441-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065441-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065441-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065441-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065441-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065441-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065441-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065441-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065441-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065441-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065441-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065441-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065441-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065441-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065441-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065441-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065441-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065441-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065441-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065441-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065441-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065441-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065441-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065441-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065441-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065441-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065441-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065441-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065441-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065441-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065441-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-03-20	`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	A065441-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065441-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065441-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065441-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065441-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065441-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065441-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065441-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065441-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065441-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065441-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065441-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065441-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065441-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065441-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065441-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065441-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065441-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065441-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065441-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065441-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065441-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065441-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065441-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065441-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065441-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065441-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065441-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065441-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065441-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065441-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065441-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065441-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065441-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065441-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065441-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065441-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065441-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065441-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065441-002	AP	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: Cefepime
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CEFEPIME HYDROCHLORIDE	1 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
I8X1O0607P	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1665088	Internal RxNorm lookup
1665093	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c654ef2e-1067-4026-8931-6a0dc2a17ad1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4878f213-798f-d240-b895-da945519fdac	Product name	5	20250221
2c48ebbc-4556-4270-89c4-74bed6fedfea	Product name	1	20250117
c050dd27-f8ee-4d60-beb5-08930938e02e	Product name	1	20231115
61f3932f-d389-4aed-124d-cf14f88e190f	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
44567-130-10	Cefepime	10 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	10		7
44567-130-10	Cefepime	20 mL in 1 VIAL	INJECTION, POWDER, FOR SOLUTION	20		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
44567-130-10	EA - Each	44567-130	2842f83a-0a0f-4d3f-8d94-450c21c8038e	1	2022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
44567-130	CEFEPIME INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]	4	Current NDC, Legacy NDC, 2 package rows	20231103_c654ef2e-1067-4026-8931-6a0dc2a17ad1.zip

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefepime	CEFEPIME	WG Critical Care, LLC	5fd857e5-591f-44ca-80cf-fd903660b03c	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065441 application number: ANDA065441
Cefepime	CEFEPIME	WG Critical Care, LLC	c654ef2e-1067-4026-8931-6a0dc2a17ad1	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065441 application number: ANDA065441 ndc (product): 44567-130
Cefepime	CEFEPIME	Hospira, Inc.	e80c27e2-164d-4836-ba24-c160d75dc5d3	2024-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065441 application number: ANDA065441
Cefepime	CEFEPIME	Fresenius Kabi USA, LLC	5e1695e0-1310-4cd8-a5da-ad1a7dcd1792	2023-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065441 application number: ANDA065441
cefepime	CEFEPIME HYDROCHLORIDE	Sagent Pharmaceuticals	de477f37-40f6-4295-ae72-a2ee36a8922e	2021-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065441 application number: ANDA065441

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
I8X1O0607P	CEFEPIME HYDROCHLORIDE	123171-59-5	CEFEPIME HYDROCHLORIDE
807PW4VQE3	CEFEPIME	88040-23-7	Cefepime

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1665093	cefepime 1 GM Injection	PSN	c654ef2e-1067-4026-8931-6a0dc2a17ad1	7
1665088	cefepime 2 GM Injection	PSN	c654ef2e-1067-4026-8931-6a0dc2a17ad1	7
1665093	cefepime 1000 MG Injection	SCD	c654ef2e-1067-4026-8931-6a0dc2a17ad1	7
1665088	cefepime 2000 MG Injection	SCD	c654ef2e-1067-4026-8931-6a0dc2a17ad1	7
1665093	cefepime 1 GM (as cefepime HCl) Injection	SY	c654ef2e-1067-4026-8931-6a0dc2a17ad1	7
1665088	cefepime 2 GM (as cefepime HCl) Injection	SY	c654ef2e-1067-4026-8931-6a0dc2a17ad1	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
44567-130-10	44567013010	10 VIAL in 1 CARTON (44567-130-10) / 20 mL in 1 VIAL	10 vial	2021-03-31	0000-00-00	No	No	Current