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Cefepime

These highlights do not include all the information needed to use CEFEPIME FOR INJECTION safely and effectively. See full prescribing information for CEFEPIME FOR INJECTION. CEFEPIME (cefepime hydrochloride) for injection, for intravenous or intramuscular use Initial U.S. Approval: 1996

Approved
Approval ID

80b4c811-4a71-47fb-8565-85ce9d0f782c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 15, 2021

Manufacturers
FDA

Qilu Pharmaceutical Co., Ltd.

DUNS: 653878256

Products 3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

CEFEPIME HYDROCHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code67184-1002
Application NumberANDA203704
Product Classification
M
Marketing Category
C73584
G
Generic Name
CEFEPIME HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateOctober 26, 2021
FDA Product Classification

INGREDIENTS (2)

CEFEPIME HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: I8X1O0607P
Classification: ACTIM
ARGININEInactive
Code: 94ZLA3W45F
Classification: IACT

CEFEPIME HYDROCHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code67184-1004
Application NumberANDA203704
Product Classification
M
Marketing Category
C73584
G
Generic Name
CEFEPIME HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 26, 2021
FDA Product Classification

INGREDIENTS (2)

ARGININEInactive
Code: 94ZLA3W45F
Classification: IACT
CEFEPIME HYDROCHLORIDEActive
Quantity: 2 g in 1 1
Code: I8X1O0607P
Classification: ACTIM

CEFEPIME HYDROCHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code67184-1003
Application NumberANDA203704
Product Classification
M
Marketing Category
C73584
G
Generic Name
CEFEPIME HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateOctober 26, 2021
FDA Product Classification

INGREDIENTS (2)

ARGININEInactive
Code: 94ZLA3W45F
Classification: IACT
CEFEPIME HYDROCHLORIDEActive
Quantity: 1 g in 1 1
Code: I8X1O0607P
Classification: ACTIM

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Cefepime - FDA Drug Approval Details