MedPath
FDA Product

HydrOXYzine Hydrochloride

Product approved by U.S. Food and Drug Administration (US)

Basic Information

HydrOXYzine Hydrochloride

68071-2237

Regulatory Information

68071-2237

ANDA040840

C73584

December 15, 2022

USA

Rx Only

HUMAN PRESCRIPTION DRUG LABEL

4

Company Information

010632300

Active Ingredients

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

ANHYDROUS LACTOSE

Code: 3SY5LH9PMK

Class Code: IACT

CROSPOVIDONE

Code: 2S7830E561

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

POLYETHYLENE GLYCOL 400

Code: B697894SGQ

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

HYDROXYZINE DIHYDROCHLORIDE

Quantity: 25 mg in 1 1

Code: 76755771U3

Class Code: ACTIB

Active Moieties

HYDROXYZINE

Code: 30S50YM8OG

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