NDC Code | 16590-747-56 |
Package Description | 56 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16590-747-56) |
Product NDC | 16590-747 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Opana |
Proprietary Name Suffix | Er |
Non-Proprietary Name | Oxymorphone Hydrochloride |
Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
Usage | ORAL |
Start Marketing Date | 20060622 |
Marketing Category Name | NDA |
Application Number | NDA021610 |
Manufacturer | STAT RX USA LLC |
Substance Name | OXYMORPHONE HYDROCHLORIDE |
Strength | 10 |
Strength Unit | mg/1 |
Pharmacy Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
DEA Schedule | CII |