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
d63d360a-15ec-44a4-b80d-b2a5cb5759eb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 10, 2023
Manufacturers
FDA
Apotex Corp.
DUNS: 845263701
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 Code60505-6144
Application NumberANDA203704
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefepime
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateFebruary 21, 2022
FDA Product Classification
INGREDIENTS (2)
CEFEPIME HYDROCHLORIDEActive
Quantity: 1 g in 1 1
Code: I8X1O0607P
Classification: ACTIM
ARGININEInactive
Code: 94ZLA3W45F
Classification: IACT
Cefepime
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-6145
Application NumberANDA203704
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefepime
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 21, 2022
FDA Product Classification
INGREDIENTS (2)
CEFEPIME HYDROCHLORIDEActive
Quantity: 2 g in 1 1
Code: I8X1O0607P
Classification: ACTIM
ARGININEInactive
Code: 94ZLA3W45F
Classification: IACT