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FDA Product

Hydroxyzine Hydrochloride

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

Basic Information

Hydroxyzine Hydrochloride

67296-0055

Regulatory Information

67296-0055

ANDA088618

C73584

July 14, 2011

USA

HYDROXYZINE HYDROCHLORIDETABLETS USP

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

RedPharm Drug Inc.

008039641

Active Ingredients

HYDROXYZINE HYDROCHLORIDE

Quantity: 25 mg in 1 1

Code: 76755771U3

Class Code: ACTIB

ANHYDROUS LACTOSE

Code: 3SY5LH9PMK

Class Code: IACT

CROSPOVIDONE

Code: 68401960MK

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

POLYDEXTROSE

Code: VH2XOU12IE

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

TRIACETIN

Code: XHX3C3X673

Class Code: IACT

POLYETHYLENE GLYCOL

Code: 3WJQ0SDW1A

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

CARNAUBA WAX

Code: R12CBM0EIZ

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties

HYDROXYZINE

Code: 30S50YM8OG

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