FDA.reportPublic FDA data

Fexofenadine

Product NDC
55648-987
11-digit product format
556480987
Labeler code
55648
Product ID
55648-987_865eb588-6553-4222-b98e-3759fab38f2d
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Wockhardt Limited
Application
ANDA079112
Marketing category
ANDA
Marketing start
2012-02-08
Marketing end
0000-00-00
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
180 mg/1
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55648-987-052020-01-31C16284748780-19d75b9d1-0a9b-f424-e053-dadaa90a57ceFexofenadine Tablets
55648-987-102020-01-31C16284748780-19d75b9d1-0a9b-f424-e053-dadaa90a57ceFexofenadine Tablets
55648-987-112020-01-31C16284748780-19d75b9d1-0a9b-f424-e053-dadaa90a57ceFexofenadine Tablets
55648-987-122020-01-31C16284748780-19d75b9d1-0a9b-f424-e053-dadaa90a57ceFexofenadine Tablets
55648-987-132020-01-31C16284748780-19d75b9d1-0a9b-f424-e053-dadaa90a57ceFexofenadine Tablets
55648-987-142020-01-31C16284748780-19d75b9d1-0a9b-f424-e053-dadaa90a57ceFexofenadine Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-987-05Fexofenadine2000 in 1 POUCHTABLET, FILM COATED20001
55648-987-09Fexofenadine5 in 1 BLISTER PACKTABLET, FILM COATED51
55648-987-10Fexofenadine1 in 1 CARTONTABLET, FILM COATED11
55648-987-11Fexofenadine3 in 1 CARTONTABLET, FILM COATED31
55648-987-12Fexofenadine30 in 1 BOTTLETABLET, FILM COATED301
55648-987-12Fexofenadine1 in 1 CARTONTABLET, FILM COATED11
55648-987-13Fexofenadine45 in 1 BOTTLETABLET, FILM COATED451
55648-987-13Fexofenadine1 in 1 CARTONTABLET, FILM COATED11
55648-987-14Fexofenadine45 in 1 BOTTLETABLET, FILM COATED451
55648-987-14Fexofenadine2 in 1 CARTONTABLET, FILM COATED21

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUALLERGY RELIEF (FEXOFENADINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION]1
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUFEXOFENADINE TABLET, FILM COATED [WOCKHARDT LIMITED]1
FEXOFENADINEACTIVE MOIETYE6582LOH6VFEXOFENADINE TABLET, FILM COATED [WOCKHARDT LIMITED]1
FEXOFENADINEACTIVE MOIETYE6582LOH6VALLERGY RELIEF (FEXOFENADINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLERGY RELIEF (FEXOFENADINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFEXOFENADINE TABLET, FILM COATED [WOCKHARDT LIMITED]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FEXOFENADINE TABLET, FILM COATED [WOCKHARDT LIMITED]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALLERGY RELIEF (FEXOFENADINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ALLERGY RELIEF (FEXOFENADINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTALLERGY RELIEF (FEXOFENADINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOALLERGY RELIEF (FEXOFENADINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFEXOFENADINE TABLET, FILM COATED [WOCKHARDT LIMITED]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALLERGY RELIEF (FEXOFENADINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFEXOFENADINE TABLET, FILM COATED [WOCKHARDT LIMITED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FEXOFENADINE TABLET, FILM COATED [WOCKHARDT LIMITED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLERGY RELIEF (FEXOFENADINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AALLERGY RELIEF (FEXOFENADINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFEXOFENADINE TABLET, FILM COATED [WOCKHARDT LIMITED]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XALLERGY RELIEF (FEXOFENADINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XFEXOFENADINE TABLET, FILM COATED [WOCKHARDT LIMITED]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FEXOFENADINE TABLET, FILM COATED [WOCKHARDT LIMITED]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALLERGY RELIEF (FEXOFENADINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION]1
TALCINACTIVE INGREDIENT7SEV7J4R1UFEXOFENADINE TABLET, FILM COATED [WOCKHARDT LIMITED]1
TALCINACTIVE INGREDIENT7SEV7J4R1UALLERGY RELIEF (FEXOFENADINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPALLERGY RELIEF (FEXOFENADINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFEXOFENADINE TABLET, FILM COATED [WOCKHARDT LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-987FEXOFENADINE TABLET, FILM COATED [WOCKHARDT LIMITED]1Legacy NDC, 10 package rows20120509_db8d895c-1004-4d5b-bc0d-81f192bfc7b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNdb8d895c-1004-4d5b-bc0d-81f192bfc7b01
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNefc8863d-a66f-4757-99f5-8358d9b8b17d1
997488fexofenadine HCl 30 MG Oral TabletPSNdb8d895c-1004-4d5b-bc0d-81f192bfc7b01
997501fexofenadine HCl 60 MG Oral TabletPSNdb8d895c-1004-4d5b-bc0d-81f192bfc7b01
997420fexofenadine hydrochloride 180 MG Oral TabletSCDdb8d895c-1004-4d5b-bc0d-81f192bfc7b01
997420fexofenadine hydrochloride 180 MG Oral TabletSCDefc8863d-a66f-4757-99f5-8358d9b8b17d1
997488fexofenadine hydrochloride 30 MG Oral TabletSCDdb8d895c-1004-4d5b-bc0d-81f192bfc7b01
997501fexofenadine hydrochloride 60 MG Oral TabletSCDdb8d895c-1004-4d5b-bc0d-81f192bfc7b01
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYdb8d895c-1004-4d5b-bc0d-81f192bfc7b01
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYefc8863d-a66f-4757-99f5-8358d9b8b17d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-987-05556480987052000 in 1 POUCHHistorical
55648-987-09556480987095 in 1 BLISTER PACKHistorical
55648-987-10556480987101 in 1 CARTONHistorical
55648-987-11556480987113 in 1 CARTONHistorical
55648-987-125564809871230 in 1 BOTTLEHistorical
55648-987-135564809871345 in 1 BOTTLEHistorical
55648-987-145564809871445 in 1 BOTTLEHistorical