Registrants (1)

KVK-Tech, Inc.

DUNS Number

173360061

Manufacturing Establishments (1)

KVK-Tech, Inc.

Labeler

KVK-Tech, Inc.

Registrant

KVK-Tech, Inc.

DUNS Number

173360061

Products (3)

Hydroxyzine Hydrochloride

NDC Product Code

10702-011

Application Number

ANDA040786

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 4, 2023

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

HYPROMELLOSE 2208 (3 MPA.S)Inactive

Code: 9H4L916OBUClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

HydroxyzineActive

Code: 76755771U3Class: ACTIBQuantity: 25 mg in 1 1

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Hydroxyzine Hydrochloride

NDC Product Code

10702-010

Application Number

ANDA040786

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 4, 2023

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

HYPROMELLOSE 2208 (3 MPA.S)Inactive

Code: 9H4L916OBUClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

HydroxyzineActive

Code: 76755771U3Class: ACTIBQuantity: 10 mg in 1 1

Hydroxyzine Hydrochloride

NDC Product Code

10702-012

Application Number

ANDA040786

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 4, 2023

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

HydroxyzineActive

Code: 76755771U3Class: ACTIBQuantity: 50 mg in 1 1

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

HYPROMELLOSE 2208 (3 MPA.S)Inactive

Code: 9H4L916OBUClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

Drug Labeling Information

DESCRIPTION SECTION

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.

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Hydroxyzine Hydrochloride

Registrants (1)

Manufacturing Establishments (1)

Products (3)

Hydroxyzine Hydrochloride

Hydroxyzine Hydrochloride

Hydroxyzine Hydrochloride

Drug Labeling Information

DESCRIPTION SECTION

DESCRIPTION