OPANA ER
OPANA ER(Oxymorphone Hydrochloride) Extended-Release Tablets5mg, 10mg, 20mg, and 40mgCIIRx Only
Approved
Approval ID
b639732f-8eb2-4592-aca3-86faf7e5360b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 31, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Oxymorphone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-948
Application NumberNDA021610
Product Classification
M
Marketing Category
C73594
G
Generic Name
Oxymorphone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2007
FDA Product Classification
INGREDIENTS (11)
Oxymorphone HydrochlorideActive
Quantity: 5 mg in 1 1
Code: 5Y2EI94NBC
Classification: ACTIB
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
triacetinInactive
Code: XHX3C3X673
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
Oxymorphone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-949
Application NumberNDA021610
Product Classification
M
Marketing Category
C73594
G
Generic Name
Oxymorphone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2007
FDA Product Classification
INGREDIENTS (11)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
Oxymorphone HydrochlorideActive
Quantity: 10 mg in 1 1
Code: 5Y2EI94NBC
Classification: ACTIB
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
triacetinInactive
Code: XHX3C3X673
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT