Allergy Relief

Product NDC
83324-095
11-digit product format
833240095
Labeler code
83324
Product ID
83324-095_1fd10e81-a917-79e0-e063-6394a90ac51c
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION, INC.
Application
ANDA211075
Marketing category
ANDA
Marketing start
2024-08-16
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
83324-095-15833240095153 BLISTER PACK in 1 CARTON (83324-095-15) / 5 TABLET in 1 BLISTER PACK3 blister pack2024-08-16NoNoHistorical
83324-095-30833240095301 BOTTLE, PLASTIC in 1 CARTON (83324-095-30) / 30 TABLET in 1 BOTTLE, PLASTIC2024-08-16NoNoHistorical
83324-095-45833240095451 BOTTLE, PLASTIC in 1 CARTON (83324-095-45) / 45 TABLET in 1 BOTTLE, PLASTIC2024-08-16NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
1192B-QCH-2024-0815CHAIN DRUG MARKETING ASSOCIATION, INC.2024-08-16HUMAN OTC DRUG LABEL2