| Product NDC: | 16590-767 |
| Proprietary Name: | OPANA |
| Non Proprietary Name: | OXYMORPHONE HYDROCHLORIDE |
| Active Ingredient(s): | 5 mg/1 & nbsp; OXYMORPHONE HYDROCHLORIDE |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED, EXTENDED RELEASE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 16590-767 |
| Labeler Name: | STAT RX USA LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021610 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20060622 |
| Package NDC: | 16590-767-90 |
| Package Description: | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16590-767-90) |
| NDC Code | 16590-767-90 |
| Proprietary Name | OPANA |
| Package Description | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16590-767-90) |
| Product NDC | 16590-767 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | OXYMORPHONE HYDROCHLORIDE |
| Dosage Form Name | TABLET, FILM COATED, EXTENDED RELEASE |
| Route Name | ORAL |
| Start Marketing Date | 20060622 |
| Marketing Category Name | NDA |
| Labeler Name | STAT RX USA LLC |
| Substance Name | OXYMORPHONE HYDROCHLORIDE |
| Strength Number | 5 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |