FEXOFENADINE HCL

Product NDC
76519-1182
11-digit product format
765191182
Labeler code
76519
Product ID
76519-1182_8c65af67-a4b1-41ee-e053-2995a90a4bea
Type
HUMAN OTC DRUG
Nonproprietary name
FEXOFENADINE HCL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA204507
Marketing category
ANDA
Marketing start
2018-03-26
Marketing end
0000-00-00
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
180 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
76519-1182-32022-01-28C16284748780-1d6a99b39-506e-a426-e053-dadaa90af4c21182 FEXOFENADINE HCL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76519-1182-3FEXOFENADINE HCL30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76519-1182FEXOFENADINE HCL TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 1 package rows20190629_8c65af67-a4b0-41ee-e053-2995a90a4bea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN8c65af67-a4b0-41ee-e053-2995a90a4bea1
997420fexofenadine hydrochloride 180 MG Oral TabletSCD8c65af67-a4b0-41ee-e053-2995a90a4bea1
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY8c65af67-a4b0-41ee-e053-2995a90a4bea1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76519-1182-37651911820330 TABLET, FILM COATED in 1 BOTTLE (76519-1182-3) 2018-03-260000-00-00NoNoCurrent