Fexofenadine hydrochloride

Product NDC
68071-2504
11-digit product format
680712504
Labeler code
68071
Product ID
68071-2504_c9b5cd8c-668d-b391-e053-2a95a90a7894
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA076502
Marketing category
ANDA
Marketing start
2011-01-03
Marketing end
0000-00-00
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
60 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
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
68071-2504-12023-01-30C16284748780-1f386c64a-23d1-0266-e053-dadaa90a7c1aFexofenadine HCl Tablets USP
68071-2504-92023-01-30C16284748780-1f386c64a-23d1-0266-e053-dadaa90a7c1aFexofenadine HCl Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2504-1Fexofenadine hydrochloride10 in 1 BOTTLETABLET101
68071-2504-9Fexofenadine hydrochloride90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2504FEXOFENADINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 2 package rows20210817_c9b5cd8c-668c-b391-e053-2a95a90a7894.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997501fexofenadine HCl 60 MG Oral TabletPSNc9b5cd8c-668c-b391-e053-2a95a90a78941
997501fexofenadine hydrochloride 60 MG Oral TabletSCDc9b5cd8c-668c-b391-e053-2a95a90a78941

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2504-16807125040110 TABLET in 1 BOTTLE (68071-2504-1) 10 tablet2021-08-160000-00-00NoNoCurrent
68071-2504-96807125040990 TABLET in 1 BOTTLE (68071-2504-9) 90 tablet2021-08-160000-00-00NoNoCurrent