MORPHINE SULFATE
These highlights do not include all the information needed to use Morphine Sulfate Oral Solution and Morphine Sulfate Tablets safely and effectively. See full prescribing information for Morphine Sulfate Oral Solution and Morphine Sulfate Tablets.Initial U.S. Approval: 1984
Approved
Approval ID
9740d1b2-d140-4959-a94b-843d4bf139c2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 7, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-5413
Application NumberNDA022195
Product Classification
M
Marketing Category
C73594
G
Generic Name
morphine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateApril 6, 2011
FDA Product Classification
INGREDIENTS (8)
MORPHINE SULFATEActive
Quantity: 10 mg in 5 mL
Code: X3P646A2J0
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT