HydrOXYzine Hydrochloride

Product NDC
50090-6628
11-digit product format
500906628
Labeler code
50090
Product ID
50090-6628_6b419ab6-a986-456b-9787-b5d31566f62b
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
50090-6628-05009066280090 TABLET in 1 BOTTLE (50090-6628-0) 90 tablet2023-08-25NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Rx OnlyA-S Medication Solutions2023-09-07Human Prescription Drug Label2