OPANA
These highlights do not include all the information needed to use OPANA safely and effectively. See full prescribing information for OPANA. OPANA (oxymorphone hydrochloride) tablets, CII Initial U.S. Approval: 1959
Approved
Approval ID
285e60f8-2404-47d0-a171-a4f075d6f418
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 13, 2012
Manufacturers
FDA
STAT Rx USA LLC
DUNS: 786036330
Products 1
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 Code16590-765
Application NumberNDA021611
Product Classification
M
Marketing Category
C73594
G
Generic Name
OXYMORPHONE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2011
FDA Product Classification
INGREDIENTS (5)
OXYMORPHONE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 5Y2EI94NBC
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT