| Product NDC: | 35356-380 |
| Proprietary Name: | OPANA |
| Non Proprietary Name: | Oxymorphone Hydrochloride |
| Active Ingredient(s): | 10 mg/1 & nbsp; Oxymorphone Hydrochloride |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 35356-380 |
| Labeler Name: | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021611 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20120209 |
| Package NDC: | 35356-380-01 |
| Package Description: | 120 TABLET in 1 BOTTLE (35356-380-01) |
| NDC Code | 35356-380-01 |
| Proprietary Name | OPANA |
| Package Description | 120 TABLET in 1 BOTTLE (35356-380-01) |
| Product NDC | 35356-380 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Oxymorphone Hydrochloride |
| Dosage Form Name | TABLET |
| Route Name | ORAL |
| Start Marketing Date | 20120209 |
| Marketing Category Name | NDA |
| Labeler Name | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC |
| Substance Name | OXYMORPHONE HYDROCHLORIDE |
| Strength Number | 10 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |