| NDC Code | 60793-537-01 |
|---|
| Package Description | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (60793-537-01) |
|---|
| Product NDC | 60793-537 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Troxyca Er |
|---|
| Non-Proprietary Name | Oxycodone Hydrochloride And Naltrexone Hydrochloride |
|---|
| Dosage Form | CAPSULE, EXTENDED RELEASE |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20160819 |
|---|
| Marketing Category Name | NDA |
|---|
| Application Number | NDA207621 |
|---|
| Manufacturer | Pfizer Laboratories Div Pfizer Inc |
|---|
| Substance Name | OXYCODONE HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE |
|---|
| Strength | 10; 1.2 |
|---|
| Strength Unit | mg/1; mg/1 |
|---|
| Pharmacy Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA] |
|---|
| DEA Schedule | CII |
|---|