Hydroxyzine Hydrochloride

Product NDC
72789-271
11-digit product format
727890271
Labeler code
72789
Product ID
72789-271_419e06f3-2fb6-ada1-e063-6294a90abe88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA088617
Marketing category
ANDA
Marketing start
2013-02-19
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
72789-271-307278902713030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-271-30) 2022-09-07NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
HydrOXYzine Hydrochloride Tablets USPPD-Rx Pharmaceuticals, Inc.2025-10-20HUMAN PRESCRIPTION DRUG LABEL20
HydrOXYzine Hydrochloride Tablets USPPD-Rx Pharmaceuticals, Inc.2024-10-09HUMAN PRESCRIPTION DRUG LABEL19