Hydroxyzine hydrochloride

Product NDC
50090-2818
11-digit product format
500902818
Labeler code
50090
Product ID
50090-2818_77cf43e3-5059-4255-83b4-8b66671a2881
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204279
Marketing category
ANDA
Marketing start
2014-08-20
Marketing end
0000-00-00
Substance
HYDROXYZINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2818-05009028180030 TABLET in 1 BOTTLE (50090-2818-0) 30 tablet2017-01-260000-00-00NoNoCurrent
50090-2818-35009028180320 TABLET in 1 BOTTLE, PLASTIC (50090-2818-3) 20 tablet2014-11-280000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Rx onlyA-S Medication Solutions2025-05-15HUMAN PRESCRIPTION DRUG LABEL28