NDC Code(s) : 55154-4706-1, 55154-4707-1, 55154-4708-1
Packager : Cardinal Health

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

MS CONTINmorphine sulfate TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-4706(NDC:59011-261)
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
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)(UNII: 8136Y38GY5)
HYPROMELLOSES(UNII: 3NXW29V3WO)
magnesium stearate(UNII: 70097M6I30)
polyethylene glycol(UNII: 3WJQ0SDW1A)
talc(UNII: 7SEV7J4R1U)
titanium dioxide(UNII: 15FIX9V2JP)
D&C RED NO. 7(UNII: ECW0LZ41X8)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
lactose(UNII: J2B2A4N98G)
polysorbate 80(UNII: 6OZP39ZG8H)
Product Characteristics
Color purple (Lavender) Score 2 pieces
Shape ROUND Size 7 mm
Flavor Imprint Code M;30
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-4706-1100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019516 07/01/1987
MS CONTINmorphine sulfate TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-4707(NDC:59011-262)
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
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)(UNII: 8136Y38GY5)
HYPROMELLOSES(UNII: 3NXW29V3WO)
magnesium stearate(UNII: 70097M6I30)
polyethylene glycol(UNII: 3WJQ0SDW1A)
talc(UNII: 7SEV7J4R1U)
titanium dioxide(UNII: 15FIX9V2JP)
D&C RED NO. 30(UNII: 2S42T2808B)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
hydroxypropyl cellulose(UNII: RFW2ET671P)
lactose(UNII: J2B2A4N98G)
Product Characteristics
Color orange (Orange) Score 2 pieces
Shape ROUND Size 7 mm
Flavor Imprint Code M;60
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-4707-1100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019516 07/01/1987
MS CONTINmorphine sulfate TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-4708(NDC:59011-263)
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
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)(UNII: 8136Y38GY5)
HYPROMELLOSES(UNII: 3NXW29V3WO)
magnesium stearate(UNII: 70097M6I30)
polyethylene glycol(UNII: 3WJQ0SDW1A)
talc(UNII: 7SEV7J4R1U)
titanium dioxide(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Product Characteristics
Color gray (Gray) Score 2 pieces
Shape ROUND Size 7 mm
Flavor Imprint Code 100
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-4708-1100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019516 07/01/1987

PRINCIPAL DISPLAY PANEL

NDC 59011-261-25 (Purdue Pharma L.P.)

MS Contin

(morphine sulfate controlled-release tablets)

30 mg

100 Tablets

Each controlled-release tablet contains: 30 mg morphine sulfate

Purdue Pharma L.P.

Rx Only

Warning: Keep out of reach of children.

CII

MS Contin 30mg Label

PRINCIPAL DISPLAY PANEL

NDC 59011-262-10 (Purdue Pharma L.P.)

MS Contin

(morphine sulfate controlled-release) tablets

60 mg

100 Tablets

Each controlled-release tablet contains: 60 mg morphine sulfate

Purdue Pharma L.P.

Rx Only

Warning: Keep out of reach of children.

CII

MS Contin 60 mg Label

PRINCIPAL DISPLAY PANEL

NDC 59011-263-10 (Purdue Pharma L.P.)

MS Contin

100 Tablets

(morphine sulfate controlled-release tablets)

100 mg

100 Tablets

Each controlled-release tablet contains: 100 mg morphine sulfate

Purdue Pharma L.P.

Rx Only

Warning: Keep out of reach of children.

CII

MS Contin 100 mg Label