| NDC Code | 53746-204-05 |
|---|
| Package Description | 500 TABLET in 1 BOTTLE (53746-204-05) |
|---|
| Product NDC | 53746-204 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Oxycodone And Acetaminophen |
|---|
| Non-Proprietary Name | Oxycodone And Acetaminophen |
|---|
| Dosage Form | TABLET |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20071127 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA040778 |
|---|
| Manufacturer | Amneal Pharmaceuticals of New York LLC |
|---|
| Substance Name | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
|---|
| Strength | 325; 10 |
|---|
| Strength Unit | mg/1; mg/1 |
|---|
| Pharmacy Classes | Full Opioid Agonists [MoA], Opioid Agonist [EPC] |
|---|
| DEA Schedule | CII |
|---|