Morphine Sulfate
These highlights do not include all the information needed to use MORPHINE SULFATE ORAL SOLUTION safely and effectively. See full prescribing information for MORPHINE SULFATE ORAL SOLUTION. MORPHINE SULFATE oral solution, for oral use CIIInitial U.S. Approval: 1941
Approved
Approval ID
ca359246-4674-4b32-b8b2-673d32b7112f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 15, 2024
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 080189610
Products 4
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 Code0054-0404
Application NumberNDA022195
Product Classification
M
Marketing Category
C73594
G
Generic Name
Morphine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 15, 2024
FDA Product Classification
INGREDIENTS (7)
MORPHINE SULFATEActive
Quantity: 100 mg in 5 mL
Code: X3P646A2J0
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Morphine Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0054-0517
Application NumberNDA022195
Product Classification
M
Marketing Category
C73594
G
Generic Name
Morphine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 15, 2024
FDA Product Classification
INGREDIENTS (9)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
MORPHINE SULFATEActive
Quantity: 100 mg in 5 mL
Code: X3P646A2J0
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
Morphine Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0054-0237
Application NumberNDA022195
Product Classification
M
Marketing Category
C73594
G
Generic Name
Morphine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 15, 2024
FDA Product Classification
INGREDIENTS (8)
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
MORPHINE SULFATEActive
Quantity: 10 mg in 5 mL
Code: X3P646A2J0
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Morphine Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0054-0238
Application NumberNDA022195
Product Classification
M
Marketing Category
C73594
G
Generic Name
Morphine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 15, 2024
FDA Product Classification
INGREDIENTS (10)
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MORPHINE SULFATEActive
Quantity: 20 mg in 5 mL
Code: X3P646A2J0
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT