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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 for injection, for intravenous or intramuscular useInitial U.S. Approval: 1996

Approved
Approval ID

c654ef2e-1067-4026-8931-6a0dc2a17ad1

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 31, 2022

Manufacturers
FDA

WG Critical Care, LLC

DUNS: 829274633

Products 2

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

Cefepime

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code44567-131
Application NumberANDA065441
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefepime
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 1, 2022
FDA Product Classification

INGREDIENTS (2)

CEFEPIME HYDROCHLORIDEActive
Quantity: 2 g in 20 mL
Code: I8X1O0607P
Classification: ACTIM
NATURAL LATEX RUBBERInactive
Quantity: 0 1 in 20 mL
Code: 2LQ0UUW8IN
Classification: CNTM

Cefepime

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code44567-130
Application NumberANDA065441
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefepime
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateMarch 1, 2022
FDA Product Classification

INGREDIENTS (2)

CEFEPIME HYDROCHLORIDEActive
Quantity: 1 g in 20 mL
Code: I8X1O0607P
Classification: ACTIM
NATURAL LATEX RUBBERInactive
Quantity: 0 1 in 20 mL
Code: 2LQ0UUW8IN
Classification: CNTM

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Cefepime - FDA Drug Approval Details