FDA.reportPublic FDA data

FEXOFENADINE HYDROCHLORIDE

Product NDC
62756-543
11-digit product format
627560543
Labeler code
62756
Product ID
62756-543_754f554d-91c6-4314-870c-b87e9a386153
Type
HUMAN OTC DRUG
Nonproprietary name
FEXOFENADINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA091567
Marketing category
ANDA
Marketing start
2012-02-06
Marketing end
0000-00-00
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
60 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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
62756-543-642023-01-30C16284748780-1f386c64a-0d6d-0266-e053-dadaa90a7c1aFexofenadine Hydrochloride Tablets, USP
62756-543-662023-01-30C16284748780-1f386c64a-0d6d-0266-e053-dadaa90a7c1aFexofenadine Hydrochloride Tablets, USP
62756-543-742023-01-30C16284748780-1f386c64a-0d6d-0266-e053-dadaa90a7c1aFexofenadine Hydrochloride Tablets, USP
62756-543-762023-01-30C16284748780-1f386c64a-0d6d-0266-e053-dadaa90a7c1aFexofenadine Hydrochloride Tablets, USP
62756-543-772023-01-30C16284748780-1f386c64a-0d6d-0266-e053-dadaa90a7c1aFexofenadine Hydrochloride Tablets, USP
62756-543-782023-01-30C16284748780-1f386c64a-0d6d-0266-e053-dadaa90a7c1aFexofenadine Hydrochloride Tablets, USP
62756-543-832023-01-30C16284748780-1f386c64a-0d6d-0266-e053-dadaa90a7c1aFexofenadine Hydrochloride Tablets, USP
62756-543-882023-01-30C16284748780-1f386c64a-0d6d-0266-e053-dadaa90a7c1aFexofenadine Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62756-543-64FEXOFENADINE HYDROCHLORIDE5 in 1 CARTONTABLET, FILM COATED56
62756-543-64FEXOFENADINE HYDROCHLORIDE6 in 1 BLISTER PACKTABLET, FILM COATED66
62756-543-66FEXOFENADINE HYDROCHLORIDE5 in 1 BLISTER PACKTABLET, FILM COATED56
62756-543-66FEXOFENADINE HYDROCHLORIDE2 in 1 CARTONTABLET, FILM COATED26
62756-543-74FEXOFENADINE HYDROCHLORIDE5 in 1 BLISTER PACKTABLET, FILM COATED56
62756-543-74FEXOFENADINE HYDROCHLORIDE1 in 1 CARTONTABLET, FILM COATED16
62756-543-76FEXOFENADINE HYDROCHLORIDE10 in 1 CARTONTABLET, FILM COATED106
62756-543-76FEXOFENADINE HYDROCHLORIDE6 in 1 BLISTER PACKTABLET, FILM COATED66
62756-543-77FEXOFENADINE HYDROCHLORIDE5 in 1 BLISTER PACKTABLET, FILM COATED56
62756-543-77FEXOFENADINE HYDROCHLORIDE9 in 1 CARTONTABLET, FILM COATED96
62756-543-78FEXOFENADINE HYDROCHLORIDE6 in 1 BLISTER PACKTABLET, FILM COATED66
62756-543-78FEXOFENADINE HYDROCHLORIDE15 in 1 CARTONTABLET, FILM COATED156
62756-543-83FEXOFENADINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED306
62756-543-88FEXOFENADINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1006

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]2
FEXOFENADINEACTIVE MOIETYE6582LOH6VFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-543FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]6Legacy NDC, 14 package rows20181026_04923af6-97fc-4e32-834d-1df643832d7f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN04923af6-97fc-4e32-834d-1df643832d7f6
997488fexofenadine HCl 30 MG Oral TabletPSN04923af6-97fc-4e32-834d-1df643832d7f6
997501fexofenadine HCl 60 MG Oral TabletPSN04923af6-97fc-4e32-834d-1df643832d7f6
997420fexofenadine hydrochloride 180 MG Oral TabletSCD04923af6-97fc-4e32-834d-1df643832d7f6
997488fexofenadine hydrochloride 30 MG Oral TabletSCD04923af6-97fc-4e32-834d-1df643832d7f6
997501fexofenadine hydrochloride 60 MG Oral TabletSCD04923af6-97fc-4e32-834d-1df643832d7f6
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY04923af6-97fc-4e32-834d-1df643832d7f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62756-543-156275605431530 TABLET, FILM COATED in 1 BOTTLE (62756-543-15) 2012-02-060000-00-00NoNoCurrent
62756-543-1662756054316100 TABLET, FILM COATED in 1 BOTTLE (62756-543-16) 2012-02-060000-00-00NoNoCurrent
62756-543-27627560543271 BLISTER PACK in 1 CARTON (62756-543-27) > 5 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2012-02-060000-00-00NoNoCurrent
62756-543-28627560543289 BLISTER PACK in 1 CARTON (62756-543-28) > 5 TABLET, FILM COATED in 1 BLISTER PACK9 blister pack2012-02-060000-00-00NoNoCurrent
62756-543-296275605432910 BLISTER PACK in 1 CARTON (62756-543-29) > 6 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2012-02-060000-00-00NoNoCurrent
62756-543-306275605433015 BLISTER PACK in 1 CARTON (62756-543-30) > 6 TABLET, FILM COATED in 1 BLISTER PACK15 blister pack2012-02-060000-00-00NoNoCurrent
62756-543-64627560543645 BLISTER PACK in 1 CARTON (62756-543-64) > 6 TABLET, FILM COATED in 1 BLISTER PACK5 blister pack2012-02-060000-00-00NoNoCurrent
62756-543-66627560543662 BLISTER PACK in 1 CARTON (62756-543-66) > 5 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2012-02-060000-00-00NoNoCurrent
62756-543-74627560543741 BLISTER PACK in 1 CARTON (62756-543-74) > 5 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2012-02-060000-00-00NoNoCurrent
62756-543-766275605437610 BLISTER PACK in 1 CARTON (62756-543-76) > 6 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2012-02-060000-00-00NoNoCurrent
62756-543-77627560543779 BLISTER PACK in 1 CARTON (62756-543-77) > 5 TABLET, FILM COATED in 1 BLISTER PACK9 blister pack2012-02-060000-00-00NoNoCurrent
62756-543-786275605437815 BLISTER PACK in 1 CARTON (62756-543-78) > 6 TABLET, FILM COATED in 1 BLISTER PACK15 blister pack2012-02-060000-00-00NoNoCurrent
62756-543-836275605438330 TABLET, FILM COATED in 1 BOTTLE (62756-543-83) 2012-02-060000-00-00NoNoCurrent
62756-543-8862756054388100 TABLET, FILM COATED in 1 BOTTLE (62756-543-88) 2012-02-060000-00-00NoNoCurrent
62756-543-94627560543942 BLISTER PACK in 1 CARTON (62756-543-94) > 5 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2012-02-060000-00-00NoNoCurrent
62756-543-95627560543955 BLISTER PACK in 1 CARTON (62756-543-95) > 6 TABLET, FILM COATED in 1 BLISTER PACK5 blister pack2012-02-060000-00-00NoNoCurrent