Fexofenadine

Product NDC
55648-982
11-digit product format
556480982
Labeler code
55648
Product ID
55648-982_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
60 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
55648-982-092020-01-31C16284748780-19d75b9d1-0a9b-f424-e053-dadaa90a57ceFexofenadine Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-982-08Fexofenadine6 in 1 BLISTER PACKTABLET, FILM COATED61
55648-982-09Fexofenadine2 in 1 CARTONTABLET, FILM COATED21

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUFEXOFENADINE TABLET, FILM COATED [WOCKHARDT LIMITED]1
FEXOFENADINEACTIVE MOIETYE6582LOH6VFEXOFENADINE TABLET, FILM COATED [WOCKHARDT LIMITED]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFEXOFENADINE TABLET, FILM COATED [WOCKHARDT LIMITED]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FEXOFENADINE TABLET, FILM COATED [WOCKHARDT LIMITED]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFEXOFENADINE TABLET, FILM COATED [WOCKHARDT LIMITED]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFEXOFENADINE TABLET, FILM COATED [WOCKHARDT LIMITED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FEXOFENADINE TABLET, FILM COATED [WOCKHARDT LIMITED]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFEXOFENADINE TABLET, FILM COATED [WOCKHARDT LIMITED]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XFEXOFENADINE TABLET, FILM COATED [WOCKHARDT LIMITED]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FEXOFENADINE TABLET, FILM COATED [WOCKHARDT LIMITED]1
TALCINACTIVE INGREDIENT7SEV7J4R1UFEXOFENADINE TABLET, FILM COATED [WOCKHARDT LIMITED]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFEXOFENADINE TABLET, FILM COATED [WOCKHARDT LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-982FEXOFENADINE TABLET, FILM COATED [WOCKHARDT LIMITED]1Legacy NDC, 2 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
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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-982-08556480982086 in 1 BLISTER PACKHistorical
55648-982-09556480982092 in 1 CARTONHistorical