FDA.reportPublic FDA data

Fexofenadine HCL

Product NDC
71399-8042
11-digit product format
713998042
Labeler code
71399
Product ID
71399-8042_8ac3ac9a-206b-446a-87c9-bda3b8441cd4
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCL
Dosage form
TABLET
Route
ORAL
Labeler
Akron Pharma Inc.
Application
ANDA204507
Marketing category
ANDA
Marketing start
2020-09-09
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fexofenadine HCL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FEXOFENADINE HYDROCHLORIDE180 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S068B75ZU
Rxcui997420

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
71399-8042-12023-02-28C16284748780-1f386c649-fcfa-0266-e053-dadaa90a7c1aFexofenadine Hydrochloride Tablets USP, 180 mg
71399-8042-12023-01-30C16284748780-1f386c649-fcfa-0266-e053-dadaa90a7c1aFexofenadine Hydrochloride Tablets USP, 180 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-8042-1Fexofenadine HCL100 in 1 BOTTLETABLET1004
71399-8042-3Fexofenadine HCL30 in 1 BOTTLETABLET304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-8042-1EA - Each71399-8042cca7d8ed-a975-4769-a724-d14d29a927d912021-03-02
71399-8042-3EA - Each71399-804234b15a30-0857-4a50-bf22-505caaedbb7f12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-8042FEXOFENADINE HCL TABLET [AKRON PHARMA INC.]4Current NDC, Legacy NDC, 2 package rows20240821_08023b99-0634-4ac9-afd6-4f2d2e0d2c8a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN08023b99-0634-4ac9-afd6-4f2d2e0d2c8a4
997420fexofenadine hydrochloride 180 MG Oral TabletSCD08023b99-0634-4ac9-afd6-4f2d2e0d2c8a4
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY08023b99-0634-4ac9-afd6-4f2d2e0d2c8a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71399-8042-171399804201100 TABLET in 1 BOTTLE (71399-8042-1) 100 tablet2020-09-090000-00-00NoNoCurrent
71399-8042-37139980420330 TABLET in 1 BOTTLE (71399-8042-3) 30 tablet2024-08-09NoNoCurrent