Ingredient Name Basis of Strength Strength
OXYMORPHONE HYDROCHLORIDE (UNII: 5Y2EI94NBC) (OXYMORPHONE - UNII:9VXA968E0C) OXYMORPHONE HYDROCHLORIDE 40 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES (UNII: 3NXW29V3WO)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POLYVINYL ALCOHOL (UNII: 532B59J990)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
TALC (UNII: 7SEV7J4R1U)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 9mm
Flavor Imprint Code E;40
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:35356-848-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 03/20/2012
2 NDC:35356-848-60 60 in 1 BOTTLE; Type 0: Not a Combination Product 03/20/2012
3 NDC:35356-848-90 90 in 1 BOTTLE; Type 0: Not a Combination Product 03/20/2012 02/01/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA201655 03/20/2012
OPANA ER
oxymorphone hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:35356-849(NDC:63481-817)
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 HYDROCHLORIDE 30 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES (UNII: 3NXW29V3WO)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POLYVINYL ALCOHOL (UNII: 532B59J990)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
TALC (UNII: 7SEV7J4R1U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
Product Characteristics
Color RED Score no score
Shape ROUND Size 9mm
Flavor Imprint Code E;30
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:35356-849-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 03/20/2012
2 NDC:35356-849-60 60 in 1 BOTTLE; Type 0: Not a Combination Product 03/20/2012
3 NDC:35356-849-90 90 in 1 BOTTLE; Type 0: Not a Combination Product 03/20/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA201655 03/20/2012
Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758)
Establishment
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