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
cc50d3c1-b4c8-4edc-9aa0-844d2fed45fb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 20, 2023
Manufacturers
FDA
Precision Dose, Inc.
DUNS: 035886746
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 Code68094-256
Application NumberNDA022195
Product Classification
M
Marketing Category
C73594
G
Generic Name
Morphine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateJune 30, 2023
FDA Product Classification
INGREDIENTS (9)
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
sodium benzoateInactive
Code: OJ245FE5EU
Classification: IACT
glycerinInactive
Code: PDC6A3C0OX
Classification: IACT
sorbitolInactive
Code: 506T60A25R
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
D&C Red No. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
SucraloseInactive
Code: 96K6UQ3ZD4
Classification: IACT