Morphine Sulfate
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 1941
Approved
Approval ID
649d731b-962a-45df-b043-7e0781e8a530
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2021
Manufacturers
FDA
Padagis US LLC
DUNS: 967694121
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
MORPHINE SULFATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0574-7112
Product Classification
G
Generic Name
MORPHINE SULFATE
Product Specifications
Route of AdministrationRECTAL
Effective DateJuly 8, 2019
FDA Product Classification
INGREDIENTS (7)
MORPHINE SULFATEActive
Quantity: 10 mg in 1 1
Code: X3P646A2J0
Classification: ACTIB
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYDROGENATED PALM KERNEL OILInactive
Code: FM8D1RE2VP
Classification: IACT
MORPHINE SULFATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0574-7114
Product Classification
G
Generic Name
MORPHINE SULFATE
Product Specifications
Route of AdministrationRECTAL
Effective DateJuly 8, 2019
FDA Product Classification
INGREDIENTS (7)
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
MORPHINE SULFATEActive
Quantity: 20 mg in 1 1
Code: X3P646A2J0
Classification: ACTIB
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYDROGENATED PALM KERNEL OILInactive
Code: FM8D1RE2VP
Classification: IACT
MORPHINE SULFATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0574-7110
Product Classification
G
Generic Name
MORPHINE SULFATE
Product Specifications
Route of AdministrationRECTAL
Effective DateJuly 8, 2019
FDA Product Classification
INGREDIENTS (7)
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
MORPHINE SULFATEActive
Quantity: 5 mg in 1 1
Code: X3P646A2J0
Classification: ACTIB
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYDROGENATED PALM KERNEL OILInactive
Code: FM8D1RE2VP
Classification: IACT
MORPHINE SULFATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0574-7116
Product Classification
G
Generic Name
MORPHINE SULFATE
Product Specifications
Route of AdministrationRECTAL
Effective DateJuly 8, 2019
FDA Product Classification
INGREDIENTS (7)
MORPHINE SULFATEActive
Quantity: 30 mg in 1 1
Code: X3P646A2J0
Classification: ACTIB
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYDROGENATED PALM KERNEL OILInactive
Code: FM8D1RE2VP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT