| NDC Code | 63481-815-20 |
|---|
| Package Description | 2 BLISTER PACK in 1 BOX, UNIT-DOSE (63481-815-20) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
|---|
| Product NDC | 63481-815 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Opana |
|---|
| Proprietary Name Suffix | Er |
|---|
| Non-Proprietary Name | Oxymorphone Hydrochloride |
|---|
| Dosage Form | TABLET, EXTENDED RELEASE |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20120320 |
|---|
| Marketing Category Name | NDA |
|---|
| Application Number | NDA201655 |
|---|
| Manufacturer | Endo Pharmaceuticals Inc. |
|---|
| Substance Name | OXYMORPHONE HYDROCHLORIDE |
|---|
| Strength | 15 |
|---|
| Strength Unit | mg/1 |
|---|
| Pharmacy Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
|---|
| DEA Schedule | CII |
|---|