Moexipril Hydrochloride

Manufacturing Establishments1

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

Glenmark Pharmaceuticals Limited

Labeler

Glenmark Pharmaceuticals Inc., USA

DUNS Number

677318665

Products2

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

Product Details

NDC Product Code

68462-209

Application Number

ANDA090416

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 18, 2021

Ingredients

MAGNESIUM OXIDEInactive

Code: 3A3U0GI71GClass: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OHClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

MoexiprilActive

Code: Q1UMG3UH45Class: ACTIBQuantity: 7.5 mg in 1 1

CROSPOVIDONE (120 .MU.M)Inactive

Code: 68401960MKClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WEClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT