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 to use MORPHINE SULFATE EXTENDED-RELEASE TABLETS. MORPHINE SULFATE extended-release tablets, for oral use CIIInitial U.S. Approval: 1941
Approved
Approval ID
7fc20bfa-86c2-40a0-be8e-8f5447bcee44
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 17, 2021
Manufacturers
FDA
Zydus Pharmaceuticals (USA) Inc.
DUNS: 156861945
Products 5
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 Code68382-905
Application NumberANDA076720
Product Classification
M
Marketing Category
C73584
G
Generic Name
MORPHINE SULFATE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 17, 2021
FDA Product Classification
INGREDIENTS (9)
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MORPHINE SULFATEActive
Quantity: 60 mg in 1 1
Code: X3P646A2J0
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MORPHINE SULFATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-906
Application NumberANDA077855
Product Classification
M
Marketing Category
C73584
G
Generic Name
MORPHINE SULFATE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 17, 2021
FDA Product Classification
INGREDIENTS (10)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
MORPHINE SULFATEActive
Quantity: 100 mg in 1 1
Code: X3P646A2J0
Classification: ACTIB
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MORPHINE SULFATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-904
Application NumberANDA076720
Product Classification
M
Marketing Category
C73584
G
Generic Name
MORPHINE SULFATE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 17, 2021
FDA Product Classification
INGREDIENTS (11)
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
MORPHINE SULFATEActive
Quantity: 30 mg in 1 1
Code: X3P646A2J0
Classification: ACTIB
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
MORPHINE SULFATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-907
Application NumberANDA077855
Product Classification
M
Marketing Category
C73584
G
Generic Name
MORPHINE SULFATE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 17, 2021
FDA Product Classification
INGREDIENTS (10)
MORPHINE SULFATEActive
Quantity: 200 mg in 1 1
Code: X3P646A2J0
Classification: ACTIB
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MORPHINE SULFATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-903
Application NumberANDA076733
Product Classification
M
Marketing Category
C73584
G
Generic Name
MORPHINE SULFATE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 17, 2021
FDA Product Classification
INGREDIENTS (11)
MORPHINE SULFATEActive
Quantity: 15 mg in 1 1
Code: X3P646A2J0
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT