HydrOXYzine Hydrochloride

Product NDC
50090-7582
11-digit product format
500907582
Labeler code
50090
Product ID
50090-7582_d0abf9e3-d92e-445f-b626-a81b499d6e47
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HydrOXYzine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA040840
Marketing category
ANDA
Marketing start
2009-11-11
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
25 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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7582-15009075820128 TABLET in 1 BOTTLE (50090-7582-1) 28 tablet2025-06-18NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Rx OnlyA-S Medication Solutions2025-07-09Human Prescription Drug Label5