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
d8598654-94ad-4cfb-81d2-9b68e013a428
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 31, 2022
Manufacturers
FDA
Tris Pharma Inc
DUNS: 947472119
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 Code27808-084
Application NumberANDA203518
Product Classification
M
Marketing Category
C73584
G
Generic Name
Morphine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 31, 2022
FDA Product Classification
INGREDIENTS (8)
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MORPHINE SULFATEActive
Quantity: 10 mg in 5 mL
Code: X3P646A2J0
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Morphine Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27808-082
Application NumberANDA203518
Product Classification
M
Marketing Category
C73584
G
Generic Name
Morphine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 31, 2022
FDA Product Classification
INGREDIENTS (7)
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGF
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
MORPHINE SULFATEActive
Quantity: 20 mg in 1 mL
Code: X3P646A2J0
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT