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FDA Approval

Morphine Sulfate

CompanyHospira, Inc. (DUNS: 141588017)

Effective Date

December 26, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Morphine(15 mg in 1 mL)

Products (5)

Morphine Sulfate

NDC Product Code

0409-1894

Application Number

NDA202515

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS

Effective Date

March 30, 2023

Ingredients

WATERInactive

Code: 059QF0KO0RClass: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

Code: X3P646A2J0Class: ACTIBQuantity: 15 mg in 1 mL

EDETATE DISODIUMInactive

Code: 7FLD91C86KClass: IACTQuantity: 0.2 mg in 1 mL

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACTQuantity: 0.8 mg in 1 mL

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACTQuantity: 7.4 mg in 1 mL

Morphine Sulfate

NDC Product Code

0409-1892

Application Number

NDA202515

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS

Effective Date

March 30, 2023

Ingredients

Code: X3P646A2J0Class: ACTIBQuantity: 8 mg in 1 mL

EDETATE DISODIUMInactive

Code: 7FLD91C86KClass: IACTQuantity: 0.2 mg in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACTQuantity: 0.4 mg in 1 mL

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACTQuantity: 8 mg in 1 mL

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

Morphine Sulfate

NDC Product Code

0409-1893

Application Number

NDA202515

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS

Effective Date

March 30, 2023

Ingredients

EDETATE DISODIUMInactive

Code: 7FLD91C86KClass: IACTQuantity: 0.2 mg in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

Code: X3P646A2J0Class: ACTIBQuantity: 10 mg in 1 mL

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACTQuantity: 0.4 mg in 1 mL

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACTQuantity: 7.8 mg in 1 mL

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

Morphine Sulfate

NDC Product Code

0409-1891

Application Number

NDA202515

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS

Effective Date

March 30, 2023

Ingredients

Code: X3P646A2J0Class: ACTIBQuantity: 4 mg in 1 mL

EDETATE DISODIUMInactive

Code: 7FLD91C86KClass: IACTQuantity: 0.2 mg in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACTQuantity: 0.4 mg in 1 mL

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACTQuantity: 8.4 mg in 1 mL

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

Morphine Sulfate

NDC Product Code

0409-1890

Application Number

NDA202515

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS

Effective Date

March 30, 2023

Ingredients

Code: X3P646A2J0Class: ACTIBQuantity: 2 mg in 1 mL

EDETATE DISODIUMInactive

Code: 7FLD91C86KClass: IACTQuantity: 0.2 mg in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACTQuantity: 0.4 mg in 1 mL

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACTQuantity: 8.5 mg in 1 mL

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

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