Esomeprazole magnesium
Esomeprazole DR Capsules These highlights do not include all the information needed to use ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES. ESOMEPRAZOLE MAGNESIUM delayed-release capsules, for oral use Initial U.S. Approval:1989 (omeprazole)
Approved
Approval ID
651cfdb1-d7c7-45e6-add0-f40eea7722f7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 13, 2023
Manufacturers
FDA
Granules Pharmaceuticals Inc.
DUNS: 079825711
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Esomeprazole magnesium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70010-133
Application NumberANDA217427
Product Classification
M
Marketing Category
C73584
G
Generic Name
Esomeprazole magnesium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 13, 2023
FDA Product Classification
INGREDIENTS (20)
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PW
Classification: IACT
GLYCERYL MONO AND DIPALMITOSTEARATEInactive
Code: KC98RO82HJ
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
ESOMEPRAZOLE MAGNESIUMActive
Quantity: 20 mg in 1 1
Code: R6DXU4WAY9
Classification: ACTIM
Esomeprazole magnesium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70010-134
Application NumberANDA217427
Product Classification
M
Marketing Category
C73584
G
Generic Name
Esomeprazole magnesium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 13, 2023
FDA Product Classification
INGREDIENTS (19)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PW
Classification: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
GLYCERYL MONO AND DIPALMITOSTEARATEInactive
Code: KC98RO82HJ
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ESOMEPRAZOLE MAGNESIUMActive
Quantity: 40 mg in 1 1
Code: R6DXU4WAY9
Classification: ACTIM
SHELLACInactive
Code: 46N107B71O
Classification: IACT