| NDC Code | 53746-617-01 |
|---|
| Package Description | 100 TABLET in 1 BOTTLE (53746-617-01) |
|---|
| Product NDC | 53746-617 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Tramadol Hydrochloride And Acetaminophen |
|---|
| Non-Proprietary Name | Tramadol Hydrochloride And Acetaminophen |
|---|
| Dosage Form | TABLET |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20091217 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA090485 |
|---|
| Manufacturer | Amneal Pharmaceuticals of New York LLC |
|---|
| Substance Name | ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE |
|---|
| Strength | 325; 37.5 |
|---|
| Strength Unit | mg/1; mg/1 |
|---|
| Pharmacy Classes | Full Opioid Agonists [MoA], Opioid Agonist [EPC] |
|---|
| DEA Schedule | CIV |
|---|