Hydroxyzine Hydrochloride
HydrOXYzine HYDROCHLORIDE SYRUP USP
Approved
Approval ID
85e3c789-a740-4a09-a810-9808c3d0f7d9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 9, 2015
Manufacturers
FDA
Pharmaceutical Associates, Inc.
DUNS: 044940096
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydroxyzine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0121-4822
Application NumberANDA087294
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydroxyzine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 9, 2015
FDA Product Classification
INGREDIENTS (11)
SucroseInactive
Code: C151H8M554
Classification: IACT
alcoholInactive
Code: 3K9958V90M
Classification: IACT
Hydroxyzine HydrochlorideActive
Quantity: 10 mg in 5 mL
Code: 76755771U3
Classification: ACTIB
MethylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
Peppermint oilInactive
Code: AV092KU4JH
Classification: IACT
PropylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
Propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Sodium CitrateInactive
Code: 1Q73Q2JULR
Classification: IACT
Citric Acid MonohydrateInactive
Code: 2968PHW8QP
Classification: IACT
Spearmint oilInactive
Code: C3M81465G5
Classification: IACT