MedPath

Hydroxyzine Hydrochloride

HYDROXYZINE HYDROCHLORIDE TABLETS, USP

Approved
Approval ID

adc4cb73-77c6-48ff-aaf2-b3568d53de1f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 4, 2023

Manufacturers
FDA

KVK-Tech, Inc.

DUNS: 173360061

Products 3

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 Code10702-011
Application NumberANDA040786
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydroxyzine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 4, 2023
FDA Product Classification

INGREDIENTS (10)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2208 (3 MPA.S)Inactive
Code: 9H4L916OBU
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYZINE DIHYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: 76755771U3
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

hydroxyzine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code10702-010
Application NumberANDA040786
Product Classification
M
Marketing Category
C73584
G
Generic Name
hydroxyzine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 4, 2023
FDA Product Classification

INGREDIENTS (10)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
HYPROMELLOSE 2208 (3 MPA.S)Inactive
Code: 9H4L916OBU
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
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYDROXYZINE DIHYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 76755771U3
Classification: ACTIB

Hydroxyzine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code10702-012
Application NumberANDA040786
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydroxyzine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 4, 2023
FDA Product Classification

INGREDIENTS (10)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYDROXYZINE DIHYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 76755771U3
Classification: ACTIB
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE 2208 (3 MPA.S)Inactive
Code: 9H4L916OBU
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

Drug Labeling Information

DESCRIPTION SECTION

LOINC: 34089-3Updated: 12/20/2018

DESCRIPTION

Hydroxyzine hydrochloride has the chemical name of 2-[2-[4-( p-Chloro- α-phenylbenzyl)-1-piperazinyl] ethoxy] ethanol dihydrochloride.

![chemical structure](/dailymed/image.cfm?name=01-chemical- structure.jpg&id=689813)

Hydroxyzine hydrochloride occurs as a white, odorless powder which is very soluble in water.

Each tablet for oral administration contains 10 mg, 25 mg or 50 mg hydroxyzine hydrochloride. Inactive ingredients include colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol/macrogol and titanium dioxide.

This product complies with USP dissolution test 2.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.