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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70849-200
Application NumberNDA202342
Product Classification
M
Marketing Category
C73594
G
Generic Name
esomeprazole strontium
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 22, 2016
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70849-400
Application NumberNDA202342
Product Classification
M
Marketing Category
C73594
G
Generic Name
esomeprazole strontium
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 22, 2016
FDA Product Classification
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