MECLIZINE HYDROCHLORIDE

Manufacturing Establishments1

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

Labeler

St. Mary's Medical Park Pharmacy

DUNS Number

063050751

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

NDC Product Code

60760-087

Application Number

ANDA040659

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 8, 2022

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933Class: IACT

Code: HDP7W44CIOClass: ACTIBQuantity: 25 mg in 1 1

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT