Fexofenadine HCL

Product NDC
68071-2682
11-digit product format
680712682
Labeler code
68071
Product ID
68071-2682_df39b1fc-200f-1720-e053-2a95a90a664e
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCL
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA204097
Marketing category
ANDA
Marketing start
2019-02-18
Marketing end
0000-00-00
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
180 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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
68071-2682-32025-01-30C16284748780-12cef2736-7e94-d83d-e063-dadaa90ab31fFexofenadine Hydrochloride Tablets USP, 180 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2682-3Fexofenadine HCL1 in 1 CARTONTABLET12
68071-2682-3Fexofenadine HCL30 in 1 BOTTLETABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2682FEXOFENADINE HCL TABLET [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 2 package rows20220518_ddbe1423-5fd3-5334-e053-2995a90a9472.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNddbe1423-5fd3-5334-e053-2995a90a94722
997420fexofenadine hydrochloride 180 MG Oral TabletSCDddbe1423-5fd3-5334-e053-2995a90a94722
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYddbe1423-5fd3-5334-e053-2995a90a94722

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2682-3680712682031 BOTTLE in 1 CARTON (68071-2682-3) > 30 TABLET in 1 BOTTLE1 bottle2022-04-280000-00-00NoNoCurrent