Morphine Sulfate Extended Release (Page 10 of 10)

PRINCIPAL DISPLAY PANEL — 15 mg Tablet Bottle Label

Attention Dispenser: Accompanying
Medication Guide must be provided to
the patient upon dispensing.

NDC 42858-801-01

Morphine
Sulfate
Extended-Release
Tablets

CII

15 mg

Rhodes

Rx only100 Tablets

PRINCIPAL DISPLAY PANEL -- 15 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 30 mg Tablet Bottle Label

Attention Dispenser: Accompanying
Medication Guide must be provided to
the patient upon dispensing.

NDC 42858-802-01

Morphine
Sulfate
Extended-Release
Tablets

CII

30 mg

Rhodes

Rx only100 Tablets

PRINCIPAL DISPLAY PANEL -- 30 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 60 mg Tablet Bottle Label

Attention Dispenser: Accompanying
Medication Guide must be provided to
the patient upon dispensing.

NDC 42858-803-01

Morphine
Sulfate
Extended-Release
Tablets

CII

60 mg

Rhodes

Rx only100 Tablets

PRINCIPAL DISPLAY PANEL -- 60 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100 mg Tablet Bottle Label

Attention Dispenser: Accompanying
Medication Guide must be provided to
the patient upon dispensing.

NDC 42858-804-01

Morphine
Sulfate
Extended-Release
Tablets

CII

100 mg

Rx only
100 Tablets

for use in opioid-
tolerant patientsonly

PRINCIPAL DISPLAY PANEL -- 100 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 200 mg Tablet Bottle Label

Attention Dispenser: Accompanying
Medication Guide must be provided to
the patient upon dispensing.

NDC 42858-805-01

Morphine
Sulfate
Extended-Release
Tablets

CII

200 mg

Rx only
100 Tablets

for use in opioid-
tolerant patientsonly

PRINCIPAL DISPLAY PANEL -- 200 mg Tablet Bottle Label
(click image for full-size original)
MORPHINE SULFATE EXTENDED RELEASE morphine sulfate tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42858-801
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORPHINE SULFATE (MORPHINE) MORPHINE SULFATE 15 mg
Inactive Ingredients
Ingredient Name Strength
CETOSTEARYL ALCOHOL
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
TALC
TITANIUM DIOXIDE
FD&C BLUE NO. 2
LACTOSE MONOHYDRATE
Product Characteristics
Color BLUE Score no score
Shape ROUND Size 7mm
Flavor Imprint Code ABG;15
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42858-801-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074862 01/14/2011
MORPHINE SULFATE EXTENDED RELEASE morphine sulfate tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42858-802
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORPHINE SULFATE (MORPHINE) MORPHINE SULFATE 30 mg
Inactive Ingredients
Ingredient Name Strength
CETOSTEARYL ALCOHOL
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
TALC
TITANIUM DIOXIDE
LACTOSE MONOHYDRATE
D&C RED NO. 7
FD&C BLUE NO. 1
Product Characteristics
Color PURPLE (lavender) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code ABG;30
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42858-802-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074862 01/14/2011
MORPHINE SULFATE EXTENDED RELEASE morphine sulfate tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42858-803
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORPHINE SULFATE (MORPHINE) MORPHINE SULFATE 60 mg
Inactive Ingredients
Ingredient Name Strength
CETOSTEARYL ALCOHOL
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
LACTOSE MONOHYDRATE
D&C RED NO. 30
D&C YELLOW NO. 10
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 7mm
Flavor Imprint Code ABG;60
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42858-803-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074862 01/14/2011
MORPHINE SULFATE EXTENDED RELEASE morphine sulfate tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42858-804
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORPHINE SULFATE (MORPHINE) MORPHINE SULFATE 100 mg
Inactive Ingredients
Ingredient Name Strength
CETOSTEARYL ALCOHOL
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
Product Characteristics
Color GRAY Score no score
Shape ROUND Size 7mm
Flavor Imprint Code ABG;100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42858-804-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074769 01/14/2011
MORPHINE SULFATE EXTENDED RELEASE morphine sulfate tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42858-805
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORPHINE SULFATE (MORPHINE) MORPHINE SULFATE 200 mg
Inactive Ingredients
Ingredient Name Strength
CETOSTEARYL ALCOHOL
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
FD&C BLUE NO. 1
D&C YELLOW NO. 10
Product Characteristics
Color GREEN Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code ABG;200
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42858-805-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074769 01/14/2011
Labeler — Rhodes Pharmaceuticals L. P. (831928986)
Registrant — Rhodes Pharmaceuticals L. P. (831928986)
Establishment
Name Address ID/FEI Operations
Purdue Pharmaceuticals L.P. 132080875 MANUFACTURE (42858-801), MANUFACTURE (42858-802), MANUFACTURE (42858-803), MANUFACTURE (42858-804), MANUFACTURE (42858-805)

Revised: 06/2023 Rhodes Pharmaceuticals L. P.

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