MedPath
FDA Product

HYDROXYZINE HCL

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

Basic Information

HYDROXYZINE HCL

61919-856

Regulatory Information

61919-856

ANDA040602

C73584

April 13, 2023

USA

HYDROXYZINE HCL 25mg

HUMAN PRESCRIPTION DRUG LABEL

10

Company Information

DIRECT RX

079254320

Active Ingredients

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

CARNAUBA WAX

Code: R12CBM0EIZ

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

HYDROXYZINE DIHYDROCHLORIDE

Quantity: 25 mg in 1 1

Code: 76755771U3

Class Code: ACTIB

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

TRIACETIN

Code: XHX3C3X673

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

CROSPOVIDONE

Code: 2S7830E561

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

POLYVINYL ALCOHOL, UNSPECIFIED

Code: 532B59J990

Class Code: IACT

Active Moieties

HYDROXYZINE

Code: 30S50YM8OG

ANHYDROUS LACTOSE

Code: 3SY5LH9PMK

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