| NDC Code | 50458-650-10 |
|---|
| Package Description | 10 BLISTER PACK in 1 BOX, UNIT-DOSE (50458-650-10) > 10 TABLET, COATED in 1 BLISTER PACK |
|---|
| Product NDC | 50458-650 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Ultracet |
|---|
| Non-Proprietary Name | Tramadol Hydrochloride And Acetaminophen |
|---|
| Dosage Form | TABLET, COATED |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20010815 |
|---|
| Marketing Category Name | NDA |
|---|
| Application Number | NDA021123 |
|---|
| Manufacturer | Janssen Pharmaceuticals, Inc. |
|---|
| 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 |
|---|