Hydroxyzine Hydrochloride

Product NDC
63629-8740
11-digit product format
636298740
Labeler code
63629
Product ID
63629-8740_66ed5a5e-f4d8-4fde-acf2-c7f5d453e21c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA088618
Marketing category
ANDA
Marketing start
2012-10-09
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
25 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
63629-8740-163629874001100 TABLET, FILM COATED in 1 BOTTLE (63629-8740-1) 2021-08-27NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
HydrOXYzine Hydrochloride Tablets USPBryant Ranch Prepack2025-09-08HUMAN PRESCRIPTION DRUG LABEL103