NDC Code | 63481-817-20 |
Package Description | 2 BLISTER PACK in 1 BOX, UNIT-DOSE (63481-817-20) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
Product NDC | 63481-817 |
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 | 30 |
Strength Unit | mg/1 |
Pharmacy Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
DEA Schedule | CII |