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FDA Product

hydroxyzine pamoate

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

Basic Information

hydroxyzine pamoate

68071-4954

Regulatory Information

68071-4954

ANDA201507

C73584

May 24, 2023

USA

Rx only

HUMAN PRESCRIPTION DRUG LABEL

4

Company Information

010632300

Active Ingredients

HYDROXYZINE PAMOATE

Quantity: 25 mg in 1 1

Code: M20215MUFR

Class Code: ACTIR

Inactive Ingredients

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

Active Moieties

HYDROXYZINE

Code: 30S50YM8OG

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