| NDC Code | 21695-949-60 |
|---|
| Package Description | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (21695-949-60) |
|---|
| Product NDC | 21695-949 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Opana 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 | Rebel Distributors Corp |
|---|
| Substance Name | OXYMORPHONE HYDROCHLORIDE |
|---|
| Strength | 10 |
|---|
| Strength Unit | mg/1 |
|---|
| Pharmacy Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
|---|
| DEA Schedule | CII |
|---|