Fexofenadine hydrochloride

Product NDC
54257-001
11-digit product format
542570001
Labeler code
54257
Product ID
54257-001_f9f8e390-92e3-4314-916e-9d78d69e133e
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Magno-Humphries Labs, Inc.
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
54257-001-292023-01-30C16284748780-1f386c64a-20f2-0266-e053-dadaa90a7c1a140073ad-3153-41f4-b6a3-8a606e35f435

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54257-001-29Fexofenadine hydrochloride150 in 1 BOTTLETABLET, FILM COATED1502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54257-001FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MAGNO-HUMPHRIES LABS, INC.]2Legacy NDC, 1 package rows20190911_140073ad-3153-41f4-b6a3-8a606e35f435.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN140073ad-3153-41f4-b6a3-8a606e35f4352
997420fexofenadine hydrochloride 180 MG Oral TabletSCD140073ad-3153-41f4-b6a3-8a606e35f4352
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY140073ad-3153-41f4-b6a3-8a606e35f4352

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
54257-001-2954257000129150 TABLET, FILM COATED in 1 BOTTLE (54257-001-29) 2015-01-150000-00-00NoNoCurrent