morphine sulfate
Morphine Sulfate Extended-Release Tablets, CIIThese highlights do not include all the information needed to use morphine sulfate safely and effectively. See full prescribing information for morphine sulfate. morphine sulfate (morphine sulfate) TABLET, FILM COATED, EXTENDED RELEASE for ORAL use.Initial U.S. Approval: 1941
Approved
Approval ID
36defcbb-bbf8-4e2d-a310-d8095626fec3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 30, 2019
Manufacturers
FDA
Lake Erie Medical DBA Quality Care Products LLC
DUNS: 831276758
Products 4
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 Code35356-837
Application NumberANDA074769
Product Classification
M
Marketing Category
C73584
G
Generic Name
Morphine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 29, 2019
FDA Product Classification
INGREDIENTS (11)
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)Inactive
Code: 8136Y38GY5
Classification: IACT
MORPHINE SULFATEActive
Quantity: 200 mg in 1 1
Code: X3P646A2J0
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Morphine Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code35356-838
Application NumberANDA074862
Product Classification
M
Marketing Category
C73584
G
Generic Name
Morphine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 29, 2019
FDA Product Classification
INGREDIENTS (12)
MORPHINE SULFATEActive
Quantity: 30 mg in 1 1
Code: X3P646A2J0
Classification: ACTIB
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)Inactive
Code: 8136Y38GY5
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
D&C RED NO. 7Inactive
Code: ECW0LZ41X8
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
morphine sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code35356-833
Application NumberANDA074862
Product Classification
M
Marketing Category
C73584
G
Generic Name
morphine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 29, 2019
FDA Product Classification
INGREDIENTS (12)
MORPHINE SULFATEActive
Quantity: 60 mg in 1 1
Code: X3P646A2J0
Classification: ACTIB
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)Inactive
Code: 8136Y38GY5
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
morphine sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code35356-836
Application NumberANDA074862
Product Classification
M
Marketing Category
C73584
G
Generic Name
morphine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 29, 2019
FDA Product Classification
INGREDIENTS (11)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MORPHINE SULFATEActive
Quantity: 15 mg in 1 1
Code: X3P646A2J0
Classification: ACTIB
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)Inactive
Code: 8136Y38GY5
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT