Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
A-S Medication Solutions
A-S Medication Solutions
830016429
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
50090-4639Application Number
NDA021153Marketing Category
NDA authorized generic (C73605)Route of Administration
ORALEffective Date
June 7, 2018EsomeprazoleActive
Code: R6DXU4WAY9Class: ACTIMQuantity: 40 mg in 1 1
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
METHACRYLIC ACIDInactive
Code: 1CS02G8656Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT