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
242c2512-1d49-486b-a9c3-6905f667799e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 30, 2023
Manufacturers
FDA
SpecGx LLC
DUNS: 080679498
Products 1
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 Code0406-8003
Application NumberANDA202348
Product Classification
M
Marketing Category
C73584
G
Generic Name
morphine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 30, 2023
FDA Product Classification
INGREDIENTS (8)
MORPHINE SULFATEActive
Quantity: 20 mg in 1 mL
Code: X3P646A2J0
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT