Morphine Sulfate
These highlights do not include all the information needed to use MORPHINE SULFATE INJECTION safely and effectively. See full prescribing information for MORPHINE SULFATE INJECTION. MORPHINE SULFATE injection, for intravenous or intramuscular use, CII Initial U.S. Approval: 1941 Rx only
Approved
Approval ID
582f42e5-444e-4246-af8c-e7e28097c69a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 29, 2020
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
Products 5
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 Code63323-455
Application NumberNDA204223
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateDecember 30, 2019
Generic NameMorphine Sulfate
INGREDIENTS (6)
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
MORPHINE SULFATEActive
Quantity: 5 mg in 1 mL
Code: X3P646A2J0
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
Morphine Sulfate
PRODUCT DETAILS
NDC Product Code63323-451
Application NumberNDA204223
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateDecember 30, 2019
Generic NameMorphine Sulfate
INGREDIENTS (6)
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
MORPHINE SULFATEActive
Quantity: 10 mg in 1 mL
Code: X3P646A2J0
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
Morphine Sulfate
PRODUCT DETAILS
NDC Product Code63323-458
Application NumberNDA204223
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateDecember 30, 2019
Generic NameMorphine Sulfate
INGREDIENTS (6)
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
MORPHINE SULFATEActive
Quantity: 8 mg in 1 mL
Code: X3P646A2J0
Classification: ACTIB
Morphine Sulfate
PRODUCT DETAILS
NDC Product Code63323-452
Application NumberNDA204223
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateDecember 30, 2019
Generic NameMorphine Sulfate
INGREDIENTS (6)
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
MORPHINE SULFATEActive
Quantity: 2 mg in 1 mL
Code: X3P646A2J0
Classification: ACTIB
Morphine Sulfate
PRODUCT DETAILS
NDC Product Code63323-454
Application NumberNDA204223
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateDecember 30, 2019
Generic NameMorphine Sulfate
INGREDIENTS (6)
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
MORPHINE SULFATEActive
Quantity: 4 mg in 1 mL
Code: X3P646A2J0
Classification: ACTIB