KADIAN
Approved
Approval ID
a6b1858a-e796-4cb0-8a4d-d5c521874e84
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 15, 2011
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
Products 7
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 Code16590-885
Application NumberNDA020616
Product Classification
M
Marketing Category
C73594
G
Generic Name
MORPHINE SULFATE
Product Specifications
Route of AdministrationORAL
Effective DateJune 15, 2011
FDA Product Classification
INGREDIENTS (16)
MORPHINE SULFATEActive
Quantity: 200 mg in 1 1
Code: X3P646A2J0
Classification: ACTIB
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
DIETHYL PHTHALATEInactive
Code: UF064M00AF
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MORPHINE SULFATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-740
Application NumberNDA020616
Product Classification
M
Marketing Category
C73594
G
Generic Name
MORPHINE SULFATE
Product Specifications
Route of AdministrationORAL
Effective DateJune 15, 2011
FDA Product Classification
INGREDIENTS (15)
MORPHINE SULFATEActive
Quantity: 100 mg in 1 1
Code: X3P646A2J0
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
DIETHYL PHTHALATEInactive
Code: UF064M00AF
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
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 Code16590-598
Application NumberNDA020616
Product Classification
M
Marketing Category
C73594
G
Generic Name
MORPHINE SULFATE
Product Specifications
Route of AdministrationORAL
Effective DateJune 15, 2011
FDA Product Classification
INGREDIENTS (16)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MORPHINE SULFATEActive
Quantity: 60 mg in 1 1
Code: X3P646A2J0
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
DIETHYL PHTHALATEInactive
Code: UF064M00AF
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MORPHINE SULFATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-606
Application NumberNDA020616
Product Classification
M
Marketing Category
C73594
G
Generic Name
MORPHINE SULFATE
Product Specifications
Route of AdministrationORAL
Effective DateJune 15, 2011
FDA Product Classification
INGREDIENTS (16)
MORPHINE SULFATEActive
Quantity: 50 mg in 1 1
Code: X3P646A2J0
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
DIETHYL PHTHALATEInactive
Code: UF064M00AF
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
MORPHINE SULFATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-778
Application NumberNDA020616
Product Classification
M
Marketing Category
C73594
G
Generic Name
MORPHINE SULFATE
Product Specifications
Route of AdministrationORAL
Effective DateJune 15, 2011
FDA Product Classification
INGREDIENTS (16)
MORPHINE SULFATEActive
Quantity: 80 mg in 1 1
Code: X3P646A2J0
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
DIETHYL PHTHALATEInactive
Code: UF064M00AF
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
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 Code16590-660
Application NumberNDA020616
Product Classification
M
Marketing Category
C73594
G
Generic Name
MORPHINE SULFATE
Product Specifications
Route of AdministrationORAL
Effective DateJune 15, 2011
FDA Product Classification
INGREDIENTS (15)
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MORPHINE SULFATEActive
Quantity: 30 mg in 1 1
Code: X3P646A2J0
Classification: ACTIB
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
DIETHYL PHTHALATEInactive
Code: UF064M00AF
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
MORPHINE SULFATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-697
Application NumberNDA020616
Product Classification
M
Marketing Category
C73594
G
Generic Name
MORPHINE SULFATE
Product Specifications
Route of AdministrationORAL
Effective DateJune 15, 2011
FDA Product Classification
INGREDIENTS (14)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
MORPHINE SULFATEActive
Quantity: 20 mg in 1 1
Code: X3P646A2J0
Classification: ACTIB
DIETHYL PHTHALATEInactive
Code: UF064M00AF
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT