Hydroxyzine Hydrochloride

Product NDC
72789-269
11-digit product format
727890269
Labeler code
72789
Product ID
72789-269_3caaf087-bb2f-80b0-e063-6294a90a1cfc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA088619
Marketing category
ANDA
Marketing start
2012-10-22
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
50 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
72789-269-307278902693030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-269-30) 2022-08-16NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
hydrOXYzine Hydrochloride Tablets, USPPD-Rx Pharmaceuticals, Inc.2025-08-18HUMAN PRESCRIPTION DRUG LABEL20