Leader 24HR Allergy Relief

Product NDC
70000-0725
11-digit product format
700000725
Labeler code
70000
Product ID
70000-0725_c82dd837-c3bd-4762-9b4c-d7ce25393a9b
Type
HUMAN OTC DRUG
Nonproprietary name
fexofenadine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 110, LLC. dba Leader
Application
ANDA212971
Marketing category
ANDA
Marketing start
2025-04-01
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
2S068B75ZUFEXOFENADINE HYDROCHLORIDE153439-40-8FEXOFENADINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70000-0725-1700000725011 BOTTLE in 1 CARTON (70000-0725-1) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2025-04-01NoNoHistorical
70000-0725-2700000725021 BOTTLE in 1 CARTON (70000-0725-2) / 70 TABLET, FILM COATED in 1 BOTTLE1 bottle2025-04-01NoNoHistorical
70000-0725-3700000725031 BOTTLE in 1 CARTON (70000-0725-3) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2025-04-01NoNoHistorical
70000-0725-47000007250415 BLISTER PACK in 1 CARTON (70000-0725-4) / 1 TABLET, FILM COATED in 1 BLISTER PACK15 blister pack2025-04-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Cardinal Health 24HR Allergy Relief Drug FactsCardinal Health 110, LLC. dba Leader2025-04-01HUMAN OTC DRUG LABEL2