CEPHALEXIN
Approved
Approval ID
b5da860d-9cfc-4020-bc81-11f2a01e660b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 23, 2011
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CEPHALEXIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-466
Application NumberANDA065326
Product Classification
M
Marketing Category
C73584
G
Generic Name
CEPHALEXIN
Product Specifications
Route of AdministrationORAL
Effective DateMay 5, 2011
FDA Product Classification
INGREDIENTS (6)
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
CEPHALEXINActive
Quantity: 125 mg in 5 mL
Code: OBN7UDS42Y
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
CEPHALEXIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-049
Application NumberANDA065326
Product Classification
M
Marketing Category
C73584
G
Generic Name
CEPHALEXIN
Product Specifications
Route of AdministrationORAL
Effective DateMay 5, 2011
FDA Product Classification
INGREDIENTS (6)
CEPHALEXINActive
Quantity: 250 mg in 5 mL
Code: OBN7UDS42Y
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT