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 use, CII Initial U.S. Approval: 1941
Approved
Approval ID
ee8057d1-ed12-4e18-9efa-d83504abf612
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 26, 2023
Manufacturers
FDA
Hospira, Inc.
DUNS: 141588017
Products 2
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 Code0409-2022
Application NumberNDA202515
Product Classification
M
Marketing Category
C73594
G
Generic Name
Morphine Sulfate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 28, 2023
FDA Product Classification
INGREDIENTS (7)
EDETATE DISODIUMInactive
Quantity: 0.2 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
MORPHINE SULFATEActive
Quantity: 50 mg in 1 mL
Code: X3P646A2J0
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Quantity: 0.8 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
Morphine Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0409-1896
Application NumberNDA202515
Product Classification
M
Marketing Category
C73594
G
Generic Name
Morphine Sulfate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 28, 2023
FDA Product Classification
INGREDIENTS (7)
MORPHINE SULFATEActive
Quantity: 50 mg in 1 mL
Code: X3P646A2J0
Classification: ACTIB
EDETATE DISODIUMInactive
Quantity: 0.2 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Quantity: 0.8 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT