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
9bb1fef7-4159-4dca-8a8c-37e53ccc6bab
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 2, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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
NDC Product Code63629-2301
Application NumberANDA203518
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 6, 2022
Generic NameMorphine Sulfate
INGREDIENTS (7)
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
MORPHINE SULFATEActive
Quantity: 20 mg in 1 mL
Code: X3P646A2J0
Classification: ACTIB
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGF
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT