fexofenadine hcl
Tablets
Approved
Approval ID
c23ad304-a5de-454e-a135-4eb143af2381
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 16, 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.
fexofenadine hcl
PRODUCT DETAILS
NDC Product Code71335-2165
Application NumberANDA204507
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 9, 2021
Generic Namefexofenadine hcl
INGREDIENTS (12)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FEXOFENADINE HYDROCHLORIDEActive
Quantity: 60 mg in 1 1
Code: 2S068B75ZU
Classification: ACTIB