NDC Code(s) : 0591-3740-01, 0591-3741-01, 0591-3742-01, 0591-3743-01, 0591-3744-01
Packager : Watson Laboratories, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Morphine SulfateMorphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-3740
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 SULFATE15 mg
Inactive Ingredients
Ingredient Name Strength
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
POWDERED CELLULOSE(UNII: SMD1X3XO9M)
HYPROMELLOSE(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL(UNII: 3WJQ0SDW1A)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
LACTOSE(UNII: J2B2A4N98G)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
Product Characteristics
Color BLUE Score no score
Shape ROUND Size 7 mm
Flavor Imprint Code ABG;15
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0591-3740-01100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074862 05/01/1987
Morphine SulfateMorphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-3741
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)
POWDERED CELLULOSE(UNII: SMD1X3XO9M)
HYPROMELLOSE(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL(UNII: 3WJQ0SDW1A)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
LACTOSE(UNII: J2B2A4N98G)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
D&C RED NO. 7(UNII: ECW0LZ41X8)
Product Characteristics
Color PURPLE (lavender colored) Score no score
Shape ROUND Size 7 mm
Flavor Imprint Code ABG;30
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0591-3741-01100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074862 05/01/1987
Morphine SulfateMorphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-3742
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)
POWDERED CELLULOSE(UNII: SMD1X3XO9M)
HYPROMELLOSE(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL(UNII: 3WJQ0SDW1A)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
D&C RED NO. 30(UNII: 2S42T2808B)
LACTOSE(UNII: J2B2A4N98G)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 7 mm
Flavor Imprint Code ABG;60
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0591-3742-01100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074862 05/01/1987
Morphine SulfateMorphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-3743
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)
POWDERED CELLULOSE(UNII: SMD1X3XO9M)
HYPROMELLOSE(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 Score no score
Shape ROUND Size 7 mm
Flavor Imprint Code ABG;100
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0591-3743-01100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074769 05/01/1987
Morphine SulfateMorphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-3744
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
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
POWDERED CELLULOSE(UNII: SMD1X3XO9M)
HYPROMELLOSE(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL(UNII: 3WJQ0SDW1A)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
Product Characteristics
Color GREEN Score no score
Shape ROUND Size 14 mm
Flavor Imprint Code ABG;200
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0591-3744-01100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074769 05/01/1987

PRINCIPAL DISPLAY PANEL

NDC 0591-3740-01
New NDC
Morphine
Sulfate CII
Extended-release
Tablets
15 mg
Watson® 100 Tablets Rx only

PRINCIPAL DISPLAY PANEL NDC 0591-3740-01 Morphine Sulfate CII 15mg

PRINCIPAL DISPLAY PANEL

NDC 0591-3741-01
New NDC
Morphine
Sulfate CII
Extended-release
Tablets
30 mg
Watson® 100 Tablets Rx only

PRINCIPAL DISPLAY PANEL NDC 0591-3741-01 Morphine Sulfate CII 30mg

PRINCIPAL DISPLAY PANEL

NDC 0591-3742-01
New NDC
Morphine
Sulfate CII
Extended-release
Tablets
60 mg
Watson® 100 Tablets Rx only

PRINCIPAL DISPLAY PANEL NDC 0591-3742-01 Morphine Sulfate CII 60mg

PRINCIPAL DISPLAY PANEL

NDC 0591-3743-01
New NDC
Morphine
Sulfate CII
Extended-release
Tablets
100 mg
Watson® 
100 Tablets
Rx only

for use in
opioid-tolerant
patients only

PRINCIPAL DISPLAY PANEL NDC 0591-3743-01 Morphine Sulfate CII 100mg for use in opioid-tolerant patients only

PRINCIPAL DISPLAY PANEL

NDC 0591-3744-01
New NDC
Morphine
Sulfate CII
Extended-release
Tablets
200 mg
Watson® 
100 Tablets
Rx only

for use in
opioid-tolerant
patients only

PRINCIPAL DISPLAY PANEL NDC 0591-3743-01 Morphine Sulfate CII 100mg for use in opioid-tolerant patients only