ESOMEPRAZOLE STRONTIUM
These highlights do not include all the information needed to use ESOMEPRAZOLE STRONTIUM safely and effectively. See full prescribing information for ESOMEPRAZOLE STRONTIUM. ESOMEPRAZOLE STRONTIUM delayed-release capsules, for oral use Initial U.S. Approval: 1989 (omeprazole)
Approved
Approval ID
3c916d32-f9e9-1d15-e054-00144ff88e88
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 22, 2016
Manufacturers
FDA
R2 Pharma, LLC
DUNS: 080274484
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
esomeprazole strontium
PRODUCT DETAILS
NDC Product Code70849-200
Application NumberNDA202342
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateSeptember 22, 2016
Generic Nameesomeprazole strontium
INGREDIENTS (13)
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
METHACRYLIC ACIDInactive
Code: 1CS02G8656
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
ESOMEPRAZOLE STRONTIUMActive
Quantity: 20 mg in 1 1
Code: C5N25H3803
Classification: ACTIM
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
esomeprazole strontium
PRODUCT DETAILS
NDC Product Code70849-400
Application NumberNDA202342
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateSeptember 22, 2016
Generic Nameesomeprazole strontium
INGREDIENTS (15)
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
METHACRYLIC ACIDInactive
Code: 1CS02G8656
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
ESOMEPRAZOLE STRONTIUMActive
Quantity: 40 mg in 1 1
Code: C5N25H3803
Classification: ACTIM
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT