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FDA Approval

Fexofenadine Hydrochloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company

Physicians Total Care, Inc.

DUNS: 194123980

Effective Date

January 22, 2010

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Fexofenadine(180 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Physicians Total Care, Inc.

Labeler

Physicians Total Care, Inc.

DUNS Number

194123980

Products3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Fexofenadine Hydrochloride

Product Details

NDC Product Code

54868-5409

Application Number

ANDA020872

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

February 18, 2010

Ingredients

FexofenadineActive

Code: 2S068B75ZUClass: ACTIBQuantity: 180 mg in 1 1

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

HYPROMELLOSEInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

POLYETHYLENE GLYCOLInactive

Code: 3WJQ0SDW1AClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

Fexofenadine Hydrochloride

Product Details

NDC Product Code

54868-5417

Application Number

ANDA020872

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

February 18, 2010

Ingredients

FexofenadineActive

Code: 2S068B75ZUClass: ACTIBQuantity: 60 mg in 1 1

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

HYPROMELLOSEInactive

Code: 3NXW29V3WOClass: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

POLYETHYLENE GLYCOLInactive

Code: 3WJQ0SDW1AClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Fexofenadine Hydrochloride

Product Details

NDC Product Code

54868-5468

Application Number

ANDA020872

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

February 18, 2010

Ingredients

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

FexofenadineActive

Code: 2S068B75ZUClass: ACTIBQuantity: 30 mg in 1 1

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

POLYETHYLENE GLYCOLInactive

Code: 3WJQ0SDW1AClass: IACT

HYPROMELLOSEInactive

Code: 3NXW29V3WOClass: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

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