cetirizine hydrochloride

Product NDC
72162-2339
11-digit product format
721622339
Labeler code
72162
Product ID
72162-2339_e6a15967-12aa-4d72-81ee-f2625b82c59d
Type
HUMAN OTC DRUG
Nonproprietary name
cetirizine hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090254
Marketing category
ANDA
Marketing start
2008-04-15
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
5 mg/5mL
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
64O047KTOACETIRIZINE HYDROCHLORIDE83881-52-1CETIRIZINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2339-2721622339021 BOTTLE in 1 CARTON (72162-2339-2) / 118 mL in 1 BOTTLE1 bottle2024-06-18NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Perrigo Children's Cetirizine Hydrochloride Oral Solution 1 mg/mL Drug FactsBryant Ranch Prepack2025-04-03HUMAN OTC DRUG LABEL2