Morphine Sulfate
These highlights do not include all the information needed to use Morphine Sulfate Tablets safely and effectively. See full prescribing information for Morphine Sulfate Tablets. Morphine Sulfate Tablets, CIIInitial U.S. Approval: 1984
Approved
Approval ID
680a996c-08a5-4cdb-b7bd-0ada5d8c7adf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 11, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-4973
Application NumberNDA022207
Product Classification
M
Marketing Category
C73594
G
Generic Name
Morphine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 11, 2012
FDA Product Classification
INGREDIENTS (5)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MORPHINE SULFATEActive
Quantity: 30 mg in 1 1
Code: X3P646A2J0
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
Morphine Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-3191
Application NumberNDA022207
Product Classification
M
Marketing Category
C73594
G
Generic Name
Morphine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 11, 2012
FDA Product Classification
INGREDIENTS (5)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MORPHINE SULFATEActive
Quantity: 15 mg in 1 1
Code: X3P646A2J0
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT