Esomeprazole Magnesium

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

862603186

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

68462-391

Application Number

ANDA209495

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 13, 2023

Ingredients

EsomeprazoleActive

Code: R6DXU4WAY9Class: ACTIMQuantity: 40 mg in 1 1

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OHClass: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8JClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT