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

R_x only100 Tablets

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

R_x only100 Tablets

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

R_x only100 Tablets

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

R_x only
100 Tablets

for use in opioid-
tolerant patientsonly

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

R_x only
100 Tablets

for use in opioid-
tolerant patientsonly

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.