NDC Code(s) : 46987-410-11, 46987-322-11, 46987-325-11, 46987-327-11, 46987-323-11, 46987-326-11, 46987-328-11, 46987-412-11, 46987-324-11, 46987-329-11, 46987-330-11, 46987-377-11
Packager : Actavis Kadian LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Kadianmorphine sulfate CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46987-410
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORPHINE SULFATE(UNII: X3P646A2J0)
(MORPHINE - UNII:76I7G6D29C) 		MORPHINE SULFATE10 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES(UNII: 3NXW29V3WO)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(UNII: 74G4R6TH13)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
DIETHYL PHTHALATE(UNII: UF064M00AF)
TALC(UNII: 7SEV7J4R1U)
STARCH, CORN(UNII: O8232NY3SJ)
SUCROSE(UNII: C151H8M554)
GELATIN(UNII: 2G86QN327L)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
D&C RED NO. 28(UNII: 767IP0Y5NH)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
SHELLAC(UNII: 46N107B71O)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Product Characteristics
Color BLUE (LIGHT) Score no score
Shape CAPSULE Size 14 mm
Flavor Imprint Code Kadian;10;mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:46987-410-11100 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020616 04/07/2009
Kadianmorphine sulfate CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46987-322
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORPHINE SULFATE(UNII: X3P646A2J0)
(MORPHINE - UNII:76I7G6D29C) 		MORPHINE SULFATE20 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES(UNII: 3NXW29V3WO)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(UNII: 74G4R6TH13)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
DIETHYL PHTHALATE(UNII: UF064M00AF)
TALC(UNII: 7SEV7J4R1U)
STARCH, CORN(UNII: O8232NY3SJ)
SUCROSE(UNII: C151H8M554)
GELATIN(UNII: 2G86QN327L)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
SHELLAC(UNII: 46N107B71O)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Product Characteristics
Color YELLOW Score no score
Shape CAPSULE Size 14 mm
Flavor Imprint Code Kadian;20;mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:46987-322-11100 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020616 04/07/2009
Kadianmorphine sulfate CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46987-325
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORPHINE SULFATE(UNII: X3P646A2J0)
(MORPHINE - UNII:76I7G6D29C) 		MORPHINE SULFATE30 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES(UNII: 3NXW29V3WO)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(UNII: 74G4R6TH13)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
DIETHYL PHTHALATE(UNII: UF064M00AF)
TALC(UNII: 7SEV7J4R1U)
STARCH, CORN(UNII: O8232NY3SJ)
SUCROSE(UNII: C151H8M554)
GELATIN(UNII: 2G86QN327L)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C RED NO. 3(UNII: PN2ZH5LOQY)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
SHELLAC(UNII: 46N107B71O)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Product Characteristics
Color BLUE (VIOLET) Score no score
Shape CAPSULE Size 14 mm
Flavor Imprint Code Kadian;30;mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:46987-325-11100 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020616 04/07/2009
Kadianmorphine sulfate CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46987-327
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORPHINE SULFATE(UNII: X3P646A2J0)
(MORPHINE - UNII:76I7G6D29C) 		MORPHINE SULFATE40 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES(UNII: 3NXW29V3WO)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(UNII: 74G4R6TH13)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
DIETHYL PHTHALATE(UNII: UF064M00AF)
TALC(UNII: 7SEV7J4R1U)
STARCH, CORN(UNII: O8232NY3SJ)
SUCROSE(UNII: C151H8M554)
GELATIN(UNII: 2G86QN327L)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C RED NO. 3(UNII: PN2ZH5LOQY)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
SHELLAC(UNII: 46N107B71O)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Product Characteristics
Color YELLOW, BLUE (VIOLET) Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code Kadian;40;mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:46987-327-11100 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020616 05/07/2012
Kadianmorphine sulfate CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46987-323
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORPHINE SULFATE(UNII: X3P646A2J0)
(MORPHINE - UNII:76I7G6D29C) 		MORPHINE SULFATE50 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES(UNII: 3NXW29V3WO)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(UNII: 74G4R6TH13)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
DIETHYL PHTHALATE(UNII: UF064M00AF)
TALC(UNII: 7SEV7J4R1U)
STARCH, CORN(UNII: O8232NY3SJ)
SUCROSE(UNII: C151H8M554)
GELATIN(UNII: 2G86QN327L)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
D&C RED NO. 28(UNII: 767IP0Y5NH)
SHELLAC(UNII: 46N107B71O)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Product Characteristics
Color BLUE Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code Kadian;50;mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:46987-323-11100 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020616 04/07/2009
Kadianmorphine sulfate CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46987-326
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORPHINE SULFATE(UNII: X3P646A2J0)
(MORPHINE - UNII:76I7G6D29C) 		MORPHINE SULFATE60 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES(UNII: 3NXW29V3WO)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(UNII: 74G4R6TH13)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
DIETHYL PHTHALATE(UNII: UF064M00AF)
TALC(UNII: 7SEV7J4R1U)
STARCH, CORN(UNII: O8232NY3SJ)
SUCROSE(UNII: C151H8M554)
GELATIN(UNII: 2G86QN327L)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
D&C RED NO. 28(UNII: 767IP0Y5NH)
SHELLAC(UNII: 46N107B71O)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Product Characteristics
Color PINK Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code Kadian;60;mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:46987-326-11100 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020616 04/07/2009
Kadianmorphine sulfate CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46987-328
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORPHINE SULFATE(UNII: X3P646A2J0)
(MORPHINE - UNII:76I7G6D29C) 		MORPHINE SULFATE70 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES(UNII: 3NXW29V3WO)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(UNII: 74G4R6TH13)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
DIETHYL PHTHALATE(UNII: UF064M00AF)
TALC(UNII: 7SEV7J4R1U)
STARCH, CORN(UNII: O8232NY3SJ)
SUCROSE(UNII: C151H8M554)
GELATIN(UNII: 2G86QN327L)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C RED NO. 3(UNII: PN2ZH5LOQY)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
D&C RED NO. 28(UNII: 767IP0Y5NH)
SHELLAC(UNII: 46N107B71O)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Product Characteristics
Color BLUE (VIOLET), BLUE (LIGHT) Score no score
Shape CAPSULE Size 21 mm
Flavor Imprint Code Kadian;70;mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:46987-328-11100 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020616 05/07/2012
Kadianmorphine sulfate CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46987-412
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORPHINE SULFATE(UNII: X3P646A2J0)
(MORPHINE - UNII:76I7G6D29C) 		MORPHINE SULFATE80 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES(UNII: 3NXW29V3WO)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(UNII: 74G4R6TH13)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
DIETHYL PHTHALATE(UNII: UF064M00AF)
TALC(UNII: 7SEV7J4R1U)
STARCH, CORN(UNII: O8232NY3SJ)
SUCROSE(UNII: C151H8M554)
GELATIN(UNII: 2G86QN327L)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
SHELLAC(UNII: 46N107B71O)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Product Characteristics
Color ORANGE (LIGHT) Score no score
Shape CAPSULE Size 22 mm
Flavor Imprint Code Kadian;80;mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:46987-412-11100 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020616 04/07/2009
Kadianmorphine sulfate CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46987-324
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORPHINE SULFATE(UNII: X3P646A2J0)
(MORPHINE - UNII:76I7G6D29C) 		MORPHINE SULFATE100 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES(UNII: 3NXW29V3WO)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(UNII: 74G4R6TH13)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
DIETHYL PHTHALATE(UNII: UF064M00AF)
TALC(UNII: 7SEV7J4R1U)
STARCH, CORN(UNII: O8232NY3SJ)
SUCROSE(UNII: C151H8M554)
GELATIN(UNII: 2G86QN327L)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
SHELLAC(UNII: 46N107B71O)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Product Characteristics
Color GREEN Score no score
Shape CAPSULE Size 22 mm
Flavor Imprint Code Kadian;100;mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:46987-324-11100 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020616 04/07/2009
Kadianmorphine sulfate CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46987-329
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORPHINE SULFATE(UNII: X3P646A2J0)
(MORPHINE - UNII:76I7G6D29C) 		MORPHINE SULFATE130 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES(UNII: 3NXW29V3WO)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(UNII: 74G4R6TH13)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
DIETHYL PHTHALATE(UNII: UF064M00AF)
TALC(UNII: 7SEV7J4R1U)
STARCH, CORN(UNII: O8232NY3SJ)
SUCROSE(UNII: C151H8M554)
GELATIN(UNII: 2G86QN327L)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
SHELLAC(UNII: 46N107B71O)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
Product Characteristics
Color ORANGE (LIGHT), BROWN (LIGHT) Score no score
Shape CAPSULE Size 20 mm
Flavor Imprint Code Kadian;130;mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:46987-329-11100 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020616 05/07/2012
Kadianmorphine sulfate CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46987-330
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORPHINE SULFATE(UNII: X3P646A2J0)
(MORPHINE - UNII:76I7G6D29C) 		MORPHINE SULFATE150 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES(UNII: 3NXW29V3WO)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(UNII: 74G4R6TH13)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
DIETHYL PHTHALATE(UNII: UF064M00AF)
TALC(UNII: 7SEV7J4R1U)
STARCH, CORN(UNII: O8232NY3SJ)
SUCROSE(UNII: C151H8M554)
GELATIN(UNII: 2G86QN327L)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
SHELLAC(UNII: 46N107B71O)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
Product Characteristics
Color GREEN, BROWN (LIGHT) Score no score
Shape CAPSULE Size 21 mm
Flavor Imprint Code Kadian;150;mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:46987-330-11100 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020616 05/07/2012
Kadianmorphine sulfate CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46987-377
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORPHINE SULFATE(UNII: X3P646A2J0)
(MORPHINE - UNII:76I7G6D29C) 		MORPHINE SULFATE200 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES(UNII: 3NXW29V3WO)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(UNII: 74G4R6TH13)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
DIETHYL PHTHALATE(UNII: UF064M00AF)
TALC(UNII: 7SEV7J4R1U)
STARCH, CORN(UNII: O8232NY3SJ)
SUCROSE(UNII: C151H8M554)
GELATIN(UNII: 2G86QN327L)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
SHELLAC(UNII: 46N107B71O)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
Product Characteristics
Color BROWN (LIGHT) Score no score
Shape CAPSULE Size 22 mm
Flavor Imprint Code Kadian;200;mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:46987-377-11100 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020616 04/07/2009

PRINCIPAL DISPLAY PANEL

KADIAN 10 mg Bottle Label x 100 capsules
NDC 46987-410-11

KADIAN 10 mg Bottle Label x 100 capsules NDC 46987-410-11 

PRINCIPAL DISPLAY PANEL

KADIAN 20 mg Bottle Label x 100 capsules
NDC 46987-322-11

KADIAN 20 mg Bottle Label x 100 capsules NDC 46987-322-11

PRINCIPAL DISPLAY PANEL

KADIAN 30 mg Bottle Label x 100 capsules
NDC 46987-325-11

KADIAN 30 mg Bottle Label x 100 capsules NDC 46987-325-11

PRINCIPAL DISPLAY PANEL

KADIAN 40 mg Bottle Label x 100 capsules
NDC 46987-327-11

KADIAN 40 mg Bottle Label x 100 capsules NDC 46987-327-11

PRINCIPAL DISPLAY PANEL

KADIAN 50 mg Bottle Label x 100 capsules
NDC 46987-323-11

KADIAN 50 mg Bottle Label x 100 capsules NDC 46987-323-11

PRINCIPAL DISPLAY PANEL

KADIAN 60 mg Bottle Label x 100 capsules
NDC 46987-326-11

KADIAN 60 mg Bottle Label x 100 capsules NDC 46987-326-11

PRINCIPAL DISPLAY PANEL

KADIAN 70 mg Bottle Label x 100 capsules
NDC 46987-328-11

KADIAN 70 mg Bottle Label x 100 capsules NDC 46987-328-11

PRINCIPAL DISPLAY PANEL

KADIAN 80 mg Bottle Label x 100 capsules
NDC 46987-412-11

KADIAN 80 mg Bottle Label x 100 capsules NDC 46987-412-11

PRINCIPAL DISPLAY PANEL

KADIAN 100 mg Bottle Label x 100 capsules
NDC 46987-324-11

KADIAN 100 mg Bottle Label x 100 capsules NDC 46987-324-11

PRINCIPAL DISPLAY PANEL

KADIAN 130 mg Bottle Label x 100 capsules
NDC 46987-329-11

KADIAN 130 mg Bottle Label x 100 capsules NDC 46987-329-11

PRINCIPAL DISPLAY PANEL

KADIAN 150 mg Bottle Label x 100 capsules
NDC 46987-330-11

KADIAN 150 mg Bottle Label x 100 capsules NDC 46987-330-11

PRINCIPAL DISPLAY PANEL

KADIAN 200 mg Bottle Label x 100 capsules
NDC 46987-377-11

KADIAN 200 mg Bottle Label x 100 capsules NDC 46987-377-11