Cephalexin
CEPHALEXIN FOR ORAL SUSPENSION, USPRx only
Approved
Approval ID
cb31cd1b-100d-4a24-b314-1ddcd6a95314
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 30, 2012
Manufacturers
FDA
OrchidPharma Inc
DUNS: 965395895
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 Code59834-202
Application NumberANDA065326
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cephalexin
Product Specifications
Route of AdministrationORAL
Effective DateAugust 30, 2012
FDA Product Classification
INGREDIENTS (6)
CEPHALEXINActive
Quantity: 125 mg in 5 mL
Code: OBN7UDS42Y
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
Cephalexin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59834-203
Application NumberANDA065326
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cephalexin
Product Specifications
Route of AdministrationORAL
Effective DateAugust 30, 2012
FDA Product Classification
INGREDIENTS (6)
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
CEPHALEXINActive
Quantity: 250 mg in 5 mL
Code: OBN7UDS42Y
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT