Fexofenadine Hydrochloride
These highlights do not include all the information needed to use fexofenadine hydrochloride tablets USP safely and effectively. See full prescribing information for fexofenadine hydrochloride tablets USP. Fexofenadine hydrochloride tablets USP for oral use.Initial U.S. Approval: 1996
Approved
Approval ID
6cf8da77-4272-4f88-9e5c-e83cfd80e9e9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 16, 2012
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, Inc.
DUNS: 128385585
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fexofenadine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43353-244
Application NumberANDA076447
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fexofenadine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 30, 2008
FDA Product Classification
INGREDIENTS (13)
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FEXOFENADINE HYDROCHLORIDEActive
Quantity: 180 mg in 1 1
Code: 2S068B75ZU
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT