Fexofenadine hydrochloride

Product NDC
53217-363
11-digit product format
532170363
Labeler code
53217
Product ID
53217-363_db0d052f-f9e8-4ec3-bb0e-a757c1062ff6
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA202039
Marketing category
ANDA
Marketing start
2018-02-01
Marketing end
0000-00-00
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
180 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
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
53217-363-902020-01-31C16284748780-19d75b9d0-8fb6-f424-e053-dadaa90a57ceFexofenadine HCl

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-363-90Fexofenadine hydrochloride90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-363FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20180821_10b1d212-710e-4320-910b-f3274be4dd5e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN10b1d212-710e-4320-910b-f3274be4dd5e1
997420fexofenadine hydrochloride 180 MG Oral TabletSCD10b1d212-710e-4320-910b-f3274be4dd5e1
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY10b1d212-710e-4320-910b-f3274be4dd5e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-363-905321703639090 in 1 BOTTLEHistorical