| NDC Code | 43063-599-20 |
|---|
| Package Description | 20 TABLET in 1 BOTTLE, PLASTIC (43063-599-20) |
|---|
| Product NDC | 43063-599 |
|---|
| 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 | PD-Rx Pharmaceuticals, Inc. |
|---|
| Substance Name | TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN |
|---|
| Strength | 37.5; 325 |
|---|
| Strength Unit | mg/1; mg/1 |
|---|
| Pharmacy Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
|---|
| DEA Schedule | CIV |
|---|