| NDC Code | 0115-1558-01 |
|---|
| Package Description | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0115-1558-01) |
|---|
| Product NDC | 0115-1558 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Oxycodone Hydrochloride |
|---|
| Non-Proprietary Name | Oxycodone Hydrochloride |
|---|
| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20160222 |
|---|
| Marketing Category Name | NDA AUTHORIZED GENERIC |
|---|
| Application Number | NDA022272 |
|---|
| Manufacturer | Amneal Pharmaceuticals of New York LLC |
|---|
| Substance Name | OXYCODONE HYDROCHLORIDE |
|---|
| Strength | 20 |
|---|
| Strength Unit | mg/1 |
|---|
| Pharmacy Classes | Full Opioid Agonists [MoA], Opioid Agonist [EPC] |
|---|
| DEA Schedule | CII |
|---|