| NDC Code | 0378-7104-01 |
|---|
| Package Description | 100 TABLET in 1 BOTTLE (0378-7104-01) |
|---|
| Product NDC | 0378-7104 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Oxycodone And Acetaminophen |
|---|
| Non-Proprietary Name | Oxycodone Hydrochloride And Acetaminophen |
|---|
| Dosage Form | TABLET |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20081216 |
|---|
| End Marketing Date | 20181231 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA090177 |
|---|
| Manufacturer | Mylan Pharmaceuticals Inc. |
|---|
| Substance Name | OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN |
|---|
| Strength | 5; 325 |
|---|
| Strength Unit | mg/1; mg/1 |
|---|
| Pharmacy Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
|---|
| DEA Schedule | CII |
|---|