FDA.reportPublic FDA data

FEXOFENADINE HYDROCHLORIDE

Product NDC
84324-008
11-digit product format
843240008
Labeler code
84324
Product ID
84324-008_16dc8e4f-54e3-4edd-87f8-30d072fabad1
Type
HUMAN OTC DRUG
Nonproprietary name
FEXOFENADINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
NUVICARE LLC
Application
ANDA210137
Marketing category
ANDA
Marketing start
2024-07-17
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 HYDROCHLORIDE
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84324-008-01FEXOFENADINE HYDROCHLORIDE18 in 1 BOTTLETABLET182
84324-008-02FEXOFENADINE HYDROCHLORIDE4 in 1 BLISTER PACKTABLET41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84324-008FEXOFENADINE HYDROCHLORIDE TABLET [NUVICARE LLC]1Current NDC, 1 package rows20240718_bb47b839-3f49-4818-a62c-b6d2b09b15dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNbb47b839-3f49-4818-a62c-b6d2b09b15dc2
997420fexofenadine hydrochloride 180 MG Oral TabletSCDbb47b839-3f49-4818-a62c-b6d2b09b15dc2
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYbb47b839-3f49-4818-a62c-b6d2b09b15dc2
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNec55732c-a3db-4445-a06d-0f98b21ed1341
997420fexofenadine hydrochloride 180 MG Oral TabletSCDec55732c-a3db-4445-a06d-0f98b21ed1341
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYec55732c-a3db-4445-a06d-0f98b21ed1341

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84324-008-018432400080118 TABLET in 1 BOTTLE (84324-008-01) 18 tablet2024-07-17NoNoCurrent
84324-008-02843240008024 TABLET in 1 BLISTER PACK (84324-008-02) 4 tablet2025-06-09NoNoCurrent