Fexofenadine hydrochloride

Product NDC
46122-387
11-digit product format
461220387
Labeler code
46122
Product ID
46122-387_90681bfc-1397-47f6-87c2-92abcc46a709
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amerisource Bergen
Application
ANDA202039
Marketing category
ANDA
Marketing start
2015-01-15
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
46122-387-232023-01-30C16284748780-1f386c649-a707-0266-e053-dadaa90a7c1a179cbace-1755-408c-ab6e-4844c017ace9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-387-23Fexofenadine hydrochloride1 in 1 CARTONTABLET, FILM COATED12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-387-23EA - Each46122-38738655537-b888-4ec4-ad58-d9b02eaab85112020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-387FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AMERISOURCE BERGEN]2Legacy NDC, 1 package rows20190911_179cbace-1755-408c-ab6e-4844c017ace9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN179cbace-1755-408c-ab6e-4844c017ace92
997420fexofenadine hydrochloride 180 MG Oral TabletSCD179cbace-1755-408c-ab6e-4844c017ace92
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY179cbace-1755-408c-ab6e-4844c017ace92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46122-387-23461220387231 TABLET, FILM COATED in 1 CARTON (46122-387-23) 2015-01-150000-00-00NoNoCurrent