Fexofenadine Hydrochloride
These highlights do not include all the information needed to use fexofenadine hydrochloride tablets safely and effectively. See full prescribing information for fexofenadine hydrochloride. Initial U.S. Approval: 1996
Approved
Approval ID
e5a207e4-472b-4bf9-8cd3-a018ef3a82bb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 27, 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.
Fexofenadine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-461
Application NumberANDA076502
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fexofenadine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2009
FDA Product Classification
INGREDIENTS (11)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FEXOFENADINE HYDROCHLORIDEActive
Quantity: 60 mg in 1 1
Code: 2S068B75ZU
Classification: ACTIB
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
Fexofenadine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-462
Application NumberANDA076502
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fexofenadine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2009
FDA Product Classification
INGREDIENTS (11)
FEXOFENADINE HYDROCHLORIDEActive
Quantity: 180 mg in 1 1
Code: 2S068B75ZU
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT