MECLIZINE HYDROCHLORIDE

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

DOH CENTRAL PHARMACY

DUNS Number

829348114

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

53808-1116

Application Number

ANDA040659

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 18, 2019

Ingredients

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

Code: HDP7W44CIOClass: ACTIBQuantity: 25 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT