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
Approved
Approval ID
1f53de80-efc8-4930-b3e3-fba0d026af05
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 1, 2024
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76045-006
Application NumberNDA204223
Product Classification
M
Marketing Category
C73594
G
Generic Name
Morphine Sulfate
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateAugust 10, 2018
FDA Product Classification
INGREDIENTS (7)
Morphine SulfateActive
Quantity: 5 mg in 1 mL
Code: X3P646A2J0
Classification: ACTIB
Sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
Citric Acid MonohydrateInactive
Code: 2968PHW8QP
Classification: IACT
Trisodium Citrate DihydrateInactive
Code: B22547B95K
Classification: IACT
Edetate DisodiumInactive
Code: 7FLD91C86K
Classification: IACT
Calcium ChlorideInactive
Code: M4I0D6VV5M
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Morphine Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76045-007
Application NumberNDA204223
Product Classification
M
Marketing Category
C73594
G
Generic Name
Morphine Sulfate
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateAugust 10, 2018
FDA Product Classification
INGREDIENTS (7)
Morphine SulfateActive
Quantity: 8 mg in 1 mL
Code: X3P646A2J0
Classification: ACTIB
Sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
Citric Acid MonohydrateInactive
Code: 2968PHW8QP
Classification: IACT
Edetate DisodiumInactive
Code: 7FLD91C86K
Classification: IACT
Calcium ChlorideInactive
Code: M4I0D6VV5M
Classification: IACT
Trisodium Citrate DihydrateInactive
Code: B22547B95K
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Morphine Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76045-005
Application NumberNDA204223
Product Classification
M
Marketing Category
C73594
G
Generic Name
Morphine Sulfate
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateAugust 10, 2018
FDA Product Classification
INGREDIENTS (7)
Morphine SulfateActive
Quantity: 4 mg in 1 mL
Code: X3P646A2J0
Classification: ACTIB
Trisodium Citrate DihydrateInactive
Code: B22547B95K
Classification: IACT
Citric Acid MonohydrateInactive
Code: 2968PHW8QP
Classification: IACT
Calcium ChlorideInactive
Code: M4I0D6VV5M
Classification: IACT
Edetate DisodiumInactive
Code: 7FLD91C86K
Classification: IACT
Sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Morphine Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76045-004
Application NumberNDA204223
Product Classification
M
Marketing Category
C73594
G
Generic Name
Morphine Sulfate
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateAugust 10, 2018
FDA Product Classification
INGREDIENTS (7)
Sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Morphine SulfateActive
Quantity: 2 mg in 1 mL
Code: X3P646A2J0
Classification: ACTIB
Trisodium Citrate DihydrateInactive
Code: B22547B95K
Classification: IACT
Citric Acid MonohydrateInactive
Code: 2968PHW8QP
Classification: IACT
Edetate DisodiumInactive
Code: 7FLD91C86K
Classification: IACT
Calcium ChlorideInactive
Code: M4I0D6VV5M
Classification: IACT
Morphine Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76045-008
Application NumberNDA204223
Product Classification
M
Marketing Category
C73594
G
Generic Name
Morphine Sulfate
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateAugust 10, 2018
FDA Product Classification
INGREDIENTS (7)
Trisodium Citrate DihydrateInactive
Code: B22547B95K
Classification: IACT
Citric Acid MonohydrateInactive
Code: 2968PHW8QP
Classification: IACT
Morphine SulfateActive
Quantity: 10 mg in 1 mL
Code: X3P646A2J0
Classification: ACTIB
Sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
Edetate DisodiumInactive
Code: 7FLD91C86K
Classification: IACT
Calcium ChlorideInactive
Code: M4I0D6VV5M
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT