NDC Code(s) : 0228-3227-06, 0228-3227-11, 0228-3227-50, 0228-3261-06, 0228-3261-11, 0228-3261-50, 0228-3228-06, 0228-3228-11, 0228-3228-50, 0228-3262-06, 0228-3262-11, 0228-3262-50, 0228-3229-06, 0228-3229-11, 0228-3229-50, 0228-3263-06, 0228-3263-11, 0228-3263-50, 0228-3230-06, 0228-3230-11, 0228-3230-50
Packager : Actavis Pharma, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Oxymorphone hydrochlorideOxymorphone hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0228-3227
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYMORPHONE HYDROCHLORIDE(UNII: 5Y2EI94NBC)
(OXYMORPHONE - UNII:9VXA968E0C) 		OXYMORPHONE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color PINK (LIGHT) Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code 227
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0228-3227-0660 in 1 BOTTLE Type 0: Not a Combination Product31/12/2010
2NDC:0228-3227-11100 in 1 BOTTLE Type 0: Not a Combination Product31/12/2010
3NDC:0228-3227-50500 in 1 BOTTLE Type 0: Not a Combination Product31/12/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079046 12/31/2010
Oxymorphone hydrochlorideOxymorphone hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0228-3261
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYMORPHONE HYDROCHLORIDE(UNII: 5Y2EI94NBC)
(OXYMORPHONE - UNII:9VXA968E0C) 		OXYMORPHONE HYDROCHLORIDE7.5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Product Characteristics
Color GRAY Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code 261
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0228-3261-0660 in 1 BOTTLE Type 0: Not a Combination Product31/12/2010
2NDC:0228-3261-11100 in 1 BOTTLE Type 0: Not a Combination Product31/12/2010
3NDC:0228-3261-50500 in 1 BOTTLE Type 0: Not a Combination Product31/12/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079046 12/31/2010
Oxymorphone hydrochlorideOxymorphone hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0228-3228
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYMORPHONE HYDROCHLORIDE(UNII: 5Y2EI94NBC)
(OXYMORPHONE - UNII:9VXA968E0C) 		OXYMORPHONE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code 228
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0228-3228-0660 in 1 BOTTLE Type 0: Not a Combination Product31/12/2010
2NDC:0228-3228-11100 in 1 BOTTLE Type 0: Not a Combination Product31/12/2010
3NDC:0228-3228-50500 in 1 BOTTLE Type 0: Not a Combination Product31/12/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079046 12/31/2010
Oxymorphone hydrochlorideOxymorphone hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0228-3262
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYMORPHONE HYDROCHLORIDE(UNII: 5Y2EI94NBC)
(OXYMORPHONE - UNII:9VXA968E0C) 		OXYMORPHONE HYDROCHLORIDE15 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color WHITE (TO OFF WHITE) Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code 262
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0228-3262-0660 in 1 BOTTLE Type 0: Not a Combination Product31/12/2010
2NDC:0228-3262-11100 in 1 BOTTLE Type 0: Not a Combination Product31/12/2010
3NDC:0228-3262-50500 in 1 BOTTLE Type 0: Not a Combination Product31/12/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079046 12/31/2010
Oxymorphone hydrochlorideOxymorphone hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0228-3229
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYMORPHONE HYDROCHLORIDE(UNII: 5Y2EI94NBC)
(OXYMORPHONE - UNII:9VXA968E0C) 		OXYMORPHONE HYDROCHLORIDE20 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Product Characteristics
Color BROWN (light tan to tan) Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code 229
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0228-3229-0660 in 1 BOTTLE Type 0: Not a Combination Product31/12/2010
2NDC:0228-3229-11100 in 1 BOTTLE Type 0: Not a Combination Product31/12/2010
3NDC:0228-3229-50500 in 1 BOTTLE Type 0: Not a Combination Product31/12/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079046 12/31/2010
Oxymorphone hydrochlorideOxymorphone hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0228-3263
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYMORPHONE HYDROCHLORIDE(UNII: 5Y2EI94NBC)
(OXYMORPHONE - UNII:9VXA968E0C) 		OXYMORPHONE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color PINK Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code 263
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0228-3263-0660 in 1 BOTTLE Type 0: Not a Combination Product31/12/2010
2NDC:0228-3263-11100 in 1 BOTTLE Type 0: Not a Combination Product31/12/2010
3NDC:0228-3263-50500 in 1 BOTTLE Type 0: Not a Combination Product31/12/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079046 12/31/2010
Oxymorphone hydrochlorideOxymorphone hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0228-3230
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYMORPHONE HYDROCHLORIDE(UNII: 5Y2EI94NBC)
(OXYMORPHONE - UNII:9VXA968E0C) 		OXYMORPHONE HYDROCHLORIDE40 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code 230
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0228-3230-0660 in 1 BOTTLE Type 0: Not a Combination Product31/12/2010
2NDC:0228-3230-11100 in 1 BOTTLE Type 0: Not a Combination Product31/12/2010
3NDC:0228-3230-50500 in 1 BOTTLE Type 0: Not a Combination Product31/12/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079046 12/31/2010

PRINCIPAL DISPLAY PANEL

NDC 0228-3227-06
Rx Only
Twice-A-Day (every 12 hours)
Oxymorphone
Hydrochloride
Extended-Release
Tablets
5 mg
60 tablets

1

PRINCIPAL DISPLAY PANEL

NDC 0228-3261-06
Rx Only
Twice-A-Day (every 12 hours)
Oxymorphone
Hydrochloride
Extended-Release
Tablets
7.5 mg
60 tablets 

1

PRINCIPAL DISPLAY PANEL

NDC 0228-3228-06
Rx Only
Twice-A-Day (every 12 hours)
Oxymorphone
Hydrochloride
Extended-Release
Tablets
10 mg
60 tablets

1

PRINCIPAL DISPLAY PANEL

NDC 0228-3262-06
Rx Only
Twice-A-Day (every 12 hours)
Oxymorphone
Hydrochloride
Extended-Release
Tablets
15 mg
60 tablets

1

PRINCIPAL DISPLAY PANEL

NDC 0228-3229-06
Rx Only
Twice-A-Day (every 12 hours)
Oxymorphone
Hydrochloride
Extended-Release
Tablets
20 mg
60 tablets

1

PRINCIPAL DISPLAY PANEL

NDC 0228-3263-06
Rx Only
Twice-A-Day (every 12 hours)
Oxymorphone
Hydrochloride
Extended-Release
Tablets
30 mg
60 tablets

1

PRINCIPAL DISPLAY PANEL

NDC 0228-3230-06
Rx Only
Twice-A-Day (every 12 hours)
Oxymorphone
Hydrochloride
Extended-Release
Tablets
40 mg
60 tablets

1