FDA.reportPublic FDA data

Fexofenadine Hydrochloride

Product NDC
68016-769
11-digit product format
680160769
Labeler code
68016
Product ID
68016-769_ba16adf1-6f4e-b473-e053-2a95a90a7219
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Pharmacy Value Alliance, LLC
Application
ANDA204507
Marketing category
ANDA
Marketing start
2019-06-01
Marketing end
0000-00-00
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
180 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
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
68016-769-032023-01-30C16284748780-1f386c649-a6c5-0266-e053-dadaa90a7c1aIndoor and Outdoor Allergies Original Prescription Strength NON-DROWSY ALLERGY RELIEF Fexofenadine Hydrochloride Tablets, USP 180mg/Antihistamine
68016-769-072023-01-30C16284748780-1f386c649-a6c5-0266-e053-dadaa90a7c1aIndoor and Outdoor Allergies Original Prescription Strength NON-DROWSY ALLERGY RELIEF Fexofenadine Hydrochloride Tablets, USP 180mg/Antihistamine
68016-769-452023-01-30C16284748780-1f386c649-a6c5-0266-e053-dadaa90a7c1aIndoor and Outdoor Allergies Original Prescription Strength NON-DROWSY ALLERGY RELIEF Fexofenadine Hydrochloride Tablets, USP 180mg/Antihistamine

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-769-03Fexofenadine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
68016-769-07Fexofenadine Hydrochloride15 in 1 BLISTER PACKTABLET, FILM COATED152
68016-769-45Fexofenadine Hydrochloride45 in 1 BOTTLETABLET, FILM COATED452

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-769FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [PHARMACY VALUE ALLIANCE, LLC]2Legacy NDC, 3 package rows20210131_8385745b-ca1d-1acb-e053-2a91aa0a7aab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN8385745b-ca1d-1acb-e053-2a91aa0a7aab2
997420fexofenadine hydrochloride 180 MG Oral TabletSCD8385745b-ca1d-1acb-e053-2a91aa0a7aab2
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY8385745b-ca1d-1acb-e053-2a91aa0a7aab2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68016-769-036801607690330 TABLET, FILM COATED in 1 BOTTLE (68016-769-03) 2019-06-010000-00-00NoNoCurrent
68016-769-076801607690715 TABLET, FILM COATED in 1 BLISTER PACK (68016-769-07) 2019-06-010000-00-00NoNoCurrent
68016-769-456801607694545 TABLET, FILM COATED in 1 BOTTLE (68016-769-45) 2019-06-010000-00-00NoNoCurrent