Products (1)

hydroxyzine pamoate

NDC Product Code

71335-1058

Application Number

ANDA086183

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 29, 2023

Ingredients

Hydroxyzine PamoateActive

Code: M20215MUFRClass: ACTIRQuantity: 50 mg in 1 1

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1SClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

HYDROXYPROPYL CELLULOSE (1200000 WAMW)Inactive

Code: U3JF91U133Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

Drug Labeling Information

DESCRIPTION SECTION

DESCRIPTION

Hydroxyzine pamoate is a light yellow, practically odorless powder practically insoluble in water and methanol and freely soluble in dimethylformamide. It is chemically designated as (±)-2-[2-[4-(p-Chloro-α- phenylbenzyl)-1-piperazinyl]ethoxy]ethanol 4,4’-methylenebis[3-hydroxy-2-naphthoate] (1:1) [10246-75-0] and can be structurally represented as follows:

Chemical Structure

C21H27CIN2O2•C23H16O6

M.W. 763.27

Each capsule, for oral administration, contains hydroxyzine pamoate equivalent to hydroxyzine hydrochloride 25 mg or 50 mg.

In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, sodium starch glycolate (potato), and sodium lauryl sulfate.

The capsule shell contains the following ingredients: D&C Yellow #10, FD&C Green #3, FD&C Yellow #6, gelatin, and titanium dioxide.

The edible imprinting ink contains the following ingredients: black iron oxide, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, propylene glycol, and shellac glaze.

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hydroxyzine pamoate

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Products (1)

hydroxyzine pamoate

Drug Labeling Information

DESCRIPTION SECTION

DESCRIPTION