Cephalexin
CEPHALEXIN FOR ORAL SUSPENSION USP
Approved
Approval ID
22ab5dba-bfce-498d-a644-9ca0e343b1cf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 4, 2010
Manufacturers
FDA
Carlsbad Technology, Inc.
DUNS: 781047246
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 Code61442-201
Application NumberANDA065336
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cephalexin
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2010
FDA Product Classification
INGREDIENTS (6)
CephalexinActive
Quantity: 125 mg in 5 mL
Code: OBN7UDS42Y
Classification: ACTIB
Sodium Lauryl SulfateInactive
Code: 368GB5141J
Classification: IACT
SucroseInactive
Code: C151H8M554
Classification: IACT
FD&C Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
Methylcellulose (25 CPS)Inactive
Code: BI55GG2WLI
Classification: IACT
StrawberryInactive
Code: 4J2TY8Y81V
Classification: IACT
Cephalexin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61442-202
Application NumberANDA065336
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cephalexin
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2010
FDA Product Classification
INGREDIENTS (6)
Methylcellulose (25 CPS)Inactive
Code: BI55GG2WLI
Classification: IACT
CephalexinActive
Quantity: 250 mg in 5 mL
Code: OBN7UDS42Y
Classification: ACTIB
Sodium Lauryl SulfateInactive
Code: 368GB5141J
Classification: IACT
SucroseInactive
Code: C151H8M554
Classification: IACT
FD&C Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
StrawberryInactive
Code: 4J2TY8Y81V
Classification: IACT