Fexofenadine Hydrochloride

Product NDC
43353-760
11-digit product format
433530760
Labeler code
43353
Product ID
43353-760_3b6da186-33ef-4a85-90df-f008a31ab498
Type
HUMAN OTC DRUG
Nonproprietary name
fexofenadine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077081
Marketing category
ANDA
Marketing start
2014-03-20
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
43353-760-532020-01-31C16284748780-19d75b9d0-9b1d-f424-e053-dadaa90a57ceDrug Facts
43353-760-602020-01-31C16284748780-19d75b9d0-9b1d-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-760-53Fexofenadine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301
43353-760-60Fexofenadine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-760-60EA - Each43353-760a494b8e8-82f5-46f1-ad3f-2566270ee2e112018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-760FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 2 package rows20171205_d0a79081-71e0-407d-876b-f4393fd4d1e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNd0a79081-71e0-407d-876b-f4393fd4d1e51
997420fexofenadine hydrochloride 180 MG Oral TabletSCDd0a79081-71e0-407d-876b-f4393fd4d1e51
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYd0a79081-71e0-407d-876b-f4393fd4d1e51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-760-534335307605330 in 1 BOTTLE, PLASTICHistorical
43353-760-604335307606090 in 1 BOTTLE, PLASTICHistorical