Cephalexin
These highlights do not include all the information needed to use CEPHALEXIN FOR ORAL SUSPENSION safely and effectively. See full prescribing information for CEPHALEXIN FOR ORAL SUSPENSION CEPHALEXIN for oral suspension Initial U.S. Approval: 1971
Approved
Approval ID
8d7f247a-3b42-4823-96fb-5f5c1bd94d49
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 15, 2024
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
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 Code63629-8857
Application NumberANDA210221
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cephalexin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 26, 2021
FDA Product Classification
INGREDIENTS (9)
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
CEPHALEXINActive
Quantity: 250 mg in 5 mL
Code: OBN7UDS42Y
Classification: ACTIM
SUCROSEInactive
Code: C151H8M554
Classification: IACT
METHYLCELLULOSE (15 MPA.S)Inactive
Code: NPU9M2E6L8
Classification: IACT
METHYLCELLULOSE (400 MPA.S)Inactive
Code: O0GN6F9B2Y
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STRAWBERRYInactive
Code: 4J2TY8Y81V
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT