FDA Product

MECLIZINE HYDROCHLORIDE

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

Basic Information

Product Name

MECLIZINE HYDROCHLORIDE

FDA Product Code

61919-752

Regulatory Information

NDC Product Code

61919-752

Application Number

ANDA200294

Marketing Category

C73584

Effective Date

October 29, 2015

Territorial Authority

USA

FDA Title

MECLIZINE HYDROCHLORIDE

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

1

Company Information

ManufacturerDirectRX

DUNS Number

079254320

Active Ingredients

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

MECLIZINE HYDROCHLORIDE

Quantity: 25 mg in 1 1

Code: HDP7W44CIO

Class Code: ACTIB

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

Active Moieties

MECLIZINE

Code: 3L5TQ84570

© Copyright 2025. All Rights Reserved by MedPath

Home Terms & Conditions Privacy Policy