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
NDC Product Code55700-366
Application NumberANDA203849
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 29, 2019
Generic NameMorphine sulfate
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
NDC Product Code55700-368
Application NumberANDA203849
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 29, 2019
Generic NameMorphine sulfate
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