Hydroxyzine hydrochloride

Product NDC
53217-225
11-digit product format
532170225
Labeler code
53217
Product ID
53217-225_e2984f05-4901-4976-9a71-f99381471f83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA204279
Marketing category
ANDA
Marketing start
2012-03-24
Marketing end
0000-00-00
Substance
HYDROXYZINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
76755771U3HYDROXYZINE HYDROCHLORIDE2192-20-3HYDROXYZINE HYDROCHLORIDE

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Rx onlyAidarex Pharmaceuticals LLC2016-11-14HUMAN PRESCRIPTION DRUG LABEL1