Fexofenadine Hydrochloride
Approved
Approval ID
a3d17e8d-a8ce-4e1a-9ec2-13736af1d7b5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 22, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 3
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 Code54868-5409
Application NumberANDA020872
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fexofenadine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 18, 2010
FDA Product Classification
INGREDIENTS (10)
FEXOFENADINE HYDROCHLORIDEActive
Quantity: 180 mg in 1 1
Code: 2S068B75ZU
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
Fexofenadine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5417
Application NumberANDA020872
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fexofenadine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 18, 2010
FDA Product Classification
INGREDIENTS (10)
FEXOFENADINE HYDROCHLORIDEActive
Quantity: 60 mg in 1 1
Code: 2S068B75ZU
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Fexofenadine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5468
Application NumberANDA020872
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fexofenadine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 18, 2010
FDA Product Classification
INGREDIENTS (10)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FEXOFENADINE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: 2S068B75ZU
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT