| NDC Code | 0054-4784-25 |
|---|
| Package Description | 100 TABLET in 1 BOTTLE, PLASTIC (0054-4784-25) |
|---|
| Product NDC | 0054-4784 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Roxicet |
|---|
| Non-Proprietary Name | Oxycodone And Acetaminophen |
|---|
| Dosage Form | TABLET |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 19890112 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA089775 |
|---|
| Manufacturer | Roxane Laboratories, Inc. |
|---|
| Substance Name | OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN |
|---|
| Strength | 5; 500 |
|---|
| Strength Unit | mg/1; mg/1 |
|---|
| Pharmacy Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
|---|
| DEA Schedule | CII |
|---|