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
d4286d3c-7226-47a6-9fbc-e67e60e46286
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 29, 2011
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
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 Code52959-182
Application NumberNDA022195
Product Classification
M
Marketing Category
C73594
G
Generic Name
Morphine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2011
FDA Product Classification
INGREDIENTS (5)
MORPHINE SULFATEActive
Quantity: 30 mg in 1 1
Code: X3P646A2J0
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
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 Code52959-138
Application NumberNDA022195
Product Classification
M
Marketing Category
C73594
G
Generic Name
Morphine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2011
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