Fexofenadine hydrochloride

Product NDC
0363-0095
11-digit product format
003630095
Labeler code
0363
Product ID
0363-0095_45b3aac8-2ad2-4cfa-858e-9cb8528292e6
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Walgreen CO
Application
ANDA202039
Marketing category
ANDA
Marketing start
2016-10-05
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
0363-0095-242023-01-30C16284748780-1f386c649-cce1-0266-e053-dadaa90a7c1add7a5c55-f834-4aa2-8cdf-a62154ce7dde

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0095-24Fexofenadine hydrochloride1 in 1 CARTONTABLET, FILM COATED13
0363-0095-24Fexofenadine hydrochloride24 in 1 BLISTER PACKTABLET, FILM COATED243

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0095FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [WALGREEN CO]3Legacy NDC, 2 package rows20190911_dd7a5c55-f834-4aa2-8cdf-a62154ce7dde.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNdd7a5c55-f834-4aa2-8cdf-a62154ce7dde3
997501fexofenadine HCl 60 MG Oral TabletPSNdd7a5c55-f834-4aa2-8cdf-a62154ce7dde3
997420fexofenadine hydrochloride 180 MG Oral TabletSCDdd7a5c55-f834-4aa2-8cdf-a62154ce7dde3
997501fexofenadine hydrochloride 60 MG Oral TabletSCDdd7a5c55-f834-4aa2-8cdf-a62154ce7dde3
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYdd7a5c55-f834-4aa2-8cdf-a62154ce7dde3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0095-24003630095241 BLISTER PACK in 1 CARTON (0363-0095-24) > 24 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2016-10-050000-00-00NoNoCurrent