Hydroxyzine Hydrochloride

Product NDC
72162-1332
11-digit product format
721621332
Labeler code
72162
Product ID
72162-1332_7adc75c5-71d2-48c2-9137-62e4533c7aed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040600
Marketing category
ANDA
Marketing start
2015-03-31
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
76755771U3HYDROXYZINE HYDROCHLORIDE2192-20-3Hydroxyzine Hydrochloride

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1332-37216213320330 TABLET, FILM COATED in 1 BOTTLE (72162-1332-3) 2024-04-08NoNoHistorical
72162-1332-97216213320990 TABLET, FILM COATED in 1 BOTTLE (72162-1332-9) 2024-04-08NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Hydroxyzine Hydrochloride Tablets USP, Film-Coated Rx OnlyBryant Ranch Prepack2025-03-31HUMAN PRESCRIPTION DRUG LABEL102