Is there a generic for Cefepime hydrochloride?

Yes. The FDA Orange Book lists 9 approved generic (ANDA) applications for Cefepime hydrochloride, referencing the brand CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Cefepime hydrochloride?

CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER (NDA 050821, B BRAUN) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Cefepime hydrochloride are approved?

Cefepime hydrochloride is approved in the following dosage forms: injectable, powder.

FDA Orange Book · active-ingredient family

Cefepime hydrochloride

Cefepime hydrochloride: 3 brands, 9 generics; first approved Jan 18, 1996; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 9 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

CEFEPIME AND DEXTROSE IN DUPLEX CONTAINERRLDRS

B BRAUNNDA 05082120102 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Rx	—
EQ 2GM BASE/VIAL	INJECTABLE	INJECTION	Rx	—

CEFEPIME IN PLASTIC CONTAINERRLDRS

BAXTER HLTHCARENDA 05081720082 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	INJECTABLE	INJECTION	Rx	—
EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	INJECTABLE	INJECTION	Rx	—

MAXIPIMERLD

HOSPIRA INCNDA 05067919963 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—
EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—
EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—

Abbreviated applications

Generic (ANDA) products (9)

CEFEPIME HYDROCHLORIDE

HIKMAANDA 21440220242 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Rx	AP
EQ 2GM BASE/VIAL	INJECTABLE	INJECTION	Rx	AP

CEFEPIME HYDROCHLORIDE

ASTRALANDA 21272120202 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 2GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—

CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINERRS

SAMSON MEDCLANDA 2094082018

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100GM BASE	POWDER	INTRAVENOUS	Rx	—

CEFEPIME HYDROCHLORIDE

SAGENT PHARMS INCANDA 09104820172 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Rx	AP
EQ 2GM BASE/VIAL	INJECTABLE	INJECTION	Rx	AP

CEFEPIME HYDROCHLORIDERS

QILU ANTIBIOTICSANDA 20370420163 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 500MG BASE/VIAL	INJECTABLE	INJECTION	Rx	—
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Rx	AP
EQ 2GM BASE/VIAL	INJECTABLE	INJECTION	Rx	AP

CEFEPIME HYDROCHLORIDE

HOSPIRA INCANDA 20226820122 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 2GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—

CEFEPIME HYDROCHLORIDE

CHARTWELL RXANDA 09029120103 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 500MG BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 2GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—

CEFEPIME HYDROCHLORIDE

ACS DOBFARANDA 06544120082 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Rx	AP
EQ 2GM BASE/VIAL	INJECTABLE	INJECTION	Rx	AP

CEFEPIME HYDROCHLORIDE

HOSPIRA INCANDA 06536920073 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 500MG BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 2GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—

Orange Book patent file

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

FDA approval span

Approval history

First approval

Jan 18, 1996

30 yr 11 mo ago

Most recent approval

May 22, 2024

2 yr 2 mo ago

Approvals span 1996–2024 across 12 FDA applications.

Brand (NDA) 325%

Generic (ANDA) 975%

Cefepime hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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