OPANA ER (Page 11 of 11)

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Opana ER 5mg
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Opana ER 10mg
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OPANA ER oxymorphone hydrochloride tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:21695-948(NDC:63481-907)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Oxymorphone Hydrochloride (Oxymorphone) Oxymorphone Hydrochloride 5 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
FERROSOFERRIC OXIDE
METHYLPARABEN
PROPYLENE GLYCOL
CELLULOSE, MICROCRYSTALLINE
SODIUM STEARYL FUMARATE
titanium dioxide
triacetin
POLYSORBATE 80
FERRIC OXIDE RED
Product Characteristics
Color PINK (PINK) Score no score
Shape OCTAGON (8 sided) (OCTAGON (8 sided)) Size 8mm
Flavor Imprint Code E907;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21695-948-60 60 TABLET, FILM COATED, EXTENDED RELEASE (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021610 06/22/2006
OPANA ER oxymorphone hydrochloride tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:21695-949(NDC:63481-674)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Oxymorphone Hydrochloride (Oxymorphone) Oxymorphone Hydrochloride 10 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
FERROSOFERRIC OXIDE
METHYLPARABEN
propylene glycol
CELLULOSE, MICROCRYSTALLINE
SODIUM STEARYL FUMARATE
titanium dioxide
triacetin
POLYSORBATE 80
FD&C YELLOW NO. 6
Product Characteristics
Color ORANGE (ORANGE) Score no score
Shape OCTAGON (8 sided) (OCTAGON (8 sided)) Size 8mm
Flavor Imprint Code E674;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21695-949-60 60 TABLET, FILM COATED, EXTENDED RELEASE (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021610 06/22/2006
Labeler — Rebel Distributors Corp (118802834)
Establishment
Name Address ID/FEI Operations
Rebel Distributors Corp 118802834 RELABEL, REPACK

Revised: 05/2011 Rebel Distributors Corp

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