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FDA Approval

Morphine Sulfate

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company

DUNS: 967694121

Effective Date

December 1, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Morphine(10 mg in 1 1)

Products4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Morphine Sulfate

Product Details

NDC Product Code

0574-7112

Route of Administration

RECTAL

Effective Date

July 8, 2019

Ingredients

Code: X3P646A2J0Class: ACTIBQuantity: 10 mg in 1 1

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171KClass: IACT

BUTYLATED HYDROXYANISOLEInactive

Code: REK4960K2UClass: IACT

GLYCERYL MONOSTEARATEInactive

Code: 230OU9XXE4Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

HYDROGENATED PALM KERNEL OILInactive

Code: FM8D1RE2VPClass: IACT

Morphine Sulfate

Product Details

NDC Product Code

0574-7114

Route of Administration

RECTAL

Effective Date

July 8, 2019

Ingredients

GLYCERYL MONOSTEARATEInactive

Code: 230OU9XXE4Class: IACT

Code: X3P646A2J0Class: ACTIBQuantity: 20 mg in 1 1

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171KClass: IACT

BUTYLATED HYDROXYANISOLEInactive

Code: REK4960K2UClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

HYDROGENATED PALM KERNEL OILInactive

Code: FM8D1RE2VPClass: IACT

Morphine Sulfate

Product Details

NDC Product Code

0574-7110

Route of Administration

RECTAL

Effective Date

July 8, 2019

Ingredients

BUTYLATED HYDROXYANISOLEInactive

Code: REK4960K2UClass: IACT

Code: X3P646A2J0Class: ACTIBQuantity: 5 mg in 1 1

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171KClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

GLYCERYL MONOSTEARATEInactive

Code: 230OU9XXE4Class: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

HYDROGENATED PALM KERNEL OILInactive

Code: FM8D1RE2VPClass: IACT

Morphine Sulfate

Product Details

NDC Product Code

0574-7116

Route of Administration

RECTAL

Effective Date

July 8, 2019

Ingredients

Code: X3P646A2J0Class: ACTIBQuantity: 30 mg in 1 1

BUTYLATED HYDROXYANISOLEInactive

Code: REK4960K2UClass: IACT

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171KClass: IACT

GLYCERYL MONOSTEARATEInactive

Code: 230OU9XXE4Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

HYDROGENATED PALM KERNEL OILInactive

Code: FM8D1RE2VPClass: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

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