Hydroxyzine Hydrochloride
HYDROXYZINE HYDROCHLORIDE TABLETS, USP
Approved
Approval ID
ca8886eb-f63c-4d65-8ed2-84f3ff4dd8cf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 11, 2013
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
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 Code53808-0632
Application NumberANDA040812
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydroxyzine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 11, 2013
FDA Product Classification
INGREDIENTS (11)
HYDROXYZINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 76755771U3
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT