Hydroxyzine Hydrochloride

Product NDC
50090-4117
11-digit product format
500904117
Labeler code
50090
Product ID
50090-4117_1018a246-77e1-446e-b436-30feac311856
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
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
50090-4117-05009041170030 TABLET, FILM COATED in 1 BOTTLE (50090-4117-0) 2019-02-01NoNoHistorical
50090-4117-35009041170320 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-4117-3) 2014-11-28NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
HydrOXYzine Hydrochloride Tablets USPA-S Medication Solutions2024-01-05HUMAN PRESCRIPTION DRUG LABEL13