Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
NuCare Pharmaceuticals,Inc.
NuCare Pharmaceuticals,Inc.
010632300
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Esomeprazole Magnesium
Product Details
NDC Product Code
68071-2922Application Number
ANDA210559Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 25, 2023SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUYClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
EsomeprazoleActive
Code: R6DXU4WAY9Class: ACTIMQuantity: 20 mg in 1 1
SUCROSEInactive
Code: C151H8M554Class: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8JClass: IACT
GLYCERYL MONO AND DICAPRYLOCAPRATEInactive
Code: U72Q2I8C85Class: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JGClass: IACT