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, for oral use CIIInitial U.S. Approval: 1941
Approved
Approval ID
3c847554-3b4b-4d24-a145-2ef7e9b83699
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 6, 2023
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 080189610
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 Code0054-0236
Application NumberNDA022207
Product Classification
M
Marketing Category
C73594
G
Generic Name
Morphine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 1, 2018
FDA Product Classification
INGREDIENTS (5)
MORPHINE SULFATEActive
Quantity: 30 mg in 1 1
Code: X3P646A2J0
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
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 Code0054-0235
Application NumberNDA022207
Product Classification
M
Marketing Category
C73594
G
Generic Name
Morphine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 1, 2018
FDA Product Classification
INGREDIENTS (5)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MORPHINE SULFATEActive
Quantity: 15 mg in 1 1
Code: X3P646A2J0
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT