Cefotetan
Rx only
Approved
Approval ID
33b13b93-58ce-44c7-b9a2-af3b3a333f80
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 12, 2019
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 001230762
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cefotetan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9671
Application NumberANDA091031
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefotetan
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateApril 12, 2019
FDA Product Classification
INGREDIENTS (2)
SODIUMInactive
Code: 9NEZ333N27
Classification: IACT
CEFOTETANActive
Quantity: 2 g in 1 1
Code: 48SPP0PA9Q
Classification: ACTIB
Cefotetan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9670
Application NumberANDA091031
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefotetan
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateApril 12, 2019
FDA Product Classification
INGREDIENTS (2)
CEFOTETANActive
Quantity: 1 g in 1 1
Code: 48SPP0PA9Q
Classification: ACTIB
SODIUMInactive
Code: 9NEZ333N27
Classification: IACT