Cephalexin
CEPHALEXIN FOR ORAL SUSPENSION USP, 125 mg/5 mL and 250 mg/5 mL Rx only
Approved
Approval ID
4e334e50-19c4-449b-b77f-549a461c7f84
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 17, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-551
Application NumberANDA062703
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cephalexin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 3, 2006
FDA Product Classification
INGREDIENTS (7)
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
CEPHALEXINActive
Quantity: 250 mg in 5 mL
Code: OBN7UDS42Y
Classification: ACTIB
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
Cephalexin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-789
Application NumberANDA062703
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cephalexin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 3, 2006
FDA Product Classification
INGREDIENTS (7)
CEPHALEXINActive
Quantity: 125 mg in 5 mL
Code: OBN7UDS42Y
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT