Meclizine Hydrochloride

Manufacturing Establishments1

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

Labeler

NuCare Pharmaceuticals,Inc.

DUNS Number

010632300

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

NDC Product Code

68071-2697

Application Number

ANDA084657

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 8, 2022

Ingredients

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MICROCRYSTALLINE CELLULOSE 102Inactive

Code: PNR0YF693YClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

HYDROGENATED COTTONSEED OILInactive

Code: Z82Y2C65EAClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

D&C YELLOW NO. 10 ALUMINUM LAKEInactive

Code: CQ3XH3DET6Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

Code: HDP7W44CIOClass: ACTIBQuantity: 25 mg in 1 1