| NDC Code | 64896-701-03 |
|---|
| Package Description | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64896-701-03) |
|---|
| Product NDC | 64896-701 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Oxymorphone Hydrochloride |
|---|
| Non-Proprietary Name | Oxymorphone Hydrochloride |
|---|
| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20130102 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA079087 |
|---|
| Manufacturer | Amneal Pharmaceuticals LLC |
|---|
| Substance Name | OXYMORPHONE HYDROCHLORIDE |
|---|
| Strength | 40 |
|---|
| Strength Unit | mg/1 |
|---|
| Pharmacy Classes | Full Opioid Agonists [MoA], Opioid Agonist [EPC] |
|---|
| DEA Schedule | CII |
|---|