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 CII Initial U.S. Approval: 1941
Approved
Approval ID
e9a7319a-bf1f-48db-a71e-6d4e6ead9555
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 28, 2022
Manufacturers
FDA
Winder Laboratories LLC
DUNS: 965195170
Products 3
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 Code75826-130
Application NumberANDA211454
Product Classification
M
Marketing Category
C73584
G
Generic Name
Morphine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 28, 2022
FDA Product Classification
INGREDIENTS (10)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
NITROGENInactive
Code: N762921K75
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
MORPHINE SULFATEActive
Quantity: 20 mg in 5 mL
Code: X3P646A2J0
Classification: ACTIB
Morphine Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code75826-129
Application NumberANDA211454
Product Classification
M
Marketing Category
C73584
G
Generic Name
Morphine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 28, 2022
FDA Product Classification
INGREDIENTS (10)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
NITROGENInactive
Code: N762921K75
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
MORPHINE SULFATEActive
Quantity: 10 mg in 5 mL
Code: X3P646A2J0
Classification: ACTIB
Morphine Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code75826-131
Application NumberANDA211454
Product Classification
M
Marketing Category
C73584
G
Generic Name
Morphine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 28, 2022
FDA Product Classification
INGREDIENTS (10)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
NITROGENInactive
Code: N762921K75
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
MORPHINE SULFATEActive
Quantity: 100 mg in 5 mL
Code: X3P646A2J0
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT