MedPath
FDA Product

MECLIZINE HYDROCHLORIDE

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

Basic Information

MECLIZINE HYDROCHLORIDE

16590-301

Regulatory Information

16590-301

ANDA087127

C73584

September 20, 2012

USA

HUMAN PRESCRIPTION DRUG LABEL

2

Company Information

STAT Rx USA LLC

786036330

Active Ingredients

MECLIZINE HYDROCHLORIDE

Quantity: 12.5 mg in 1 1

Code: HDP7W44CIO

Class Code: ACTIB

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

ANHYDROUS LACTOSE

Code: 3SY5LH9PMK

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

STEARIC ACID

Code: 4ELV7Z65AP

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

ISOPROPYL ALCOHOL

Code: ND2M416302

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

COLLOIDAL SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

Active Moieties

MECLIZINE

Code: 3L5TQ84570

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