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

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2015-09-16
A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2015-09-16
A204507-004FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2015-09-16
A204507-005FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2015-09-16

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fexofenadine HCLFEXOFENADINE HCLAkron Pharma Inc.08023b99-0634-4ac9-afd6-4f2d2e0d2c8a2024-08-20WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

WARNINGS

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