Morphine sulfate
These highlights do not include all the information needed to use morphine sulfate extended-release tablets safely and effectively. See full prescribing information for morphine sulfate extended-release tablets. MORPHINE sulfate extended-release tablets, for oral use CII Initial U.S. Approval: 1941
Approved
Approval ID
3256e6a3-aed7-4a38-818d-86bef7ef83f6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 30, 2019
Manufacturers
FDA
Lake Erie Medical DBA Quality Care Products LLC
DUNS: 831276758
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 Code55700-366
Application NumberANDA203849
Product Classification
M
Marketing Category
C73584
G
Generic Name
Morphine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 29, 2019
FDA Product Classification
INGREDIENTS (9)
MORPHINE SULFATEActive
Quantity: 15 mg in 1 1
Code: X3P646A2J0
Classification: ACTIB
HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%)Inactive
Code: 12VCE9HR9E
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
Morphine sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55700-368
Application NumberANDA203849
Product Classification
M
Marketing Category
C73584
G
Generic Name
Morphine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 29, 2019
FDA Product Classification
INGREDIENTS (10)
MORPHINE SULFATEActive
Quantity: 60 mg in 1 1
Code: X3P646A2J0
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%)Inactive
Code: 12VCE9HR9E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT