| NDC Code | 35356-770-60 |
|---|
| Package Description | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (35356-770-60) |
|---|
| Product NDC | 35356-770 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Nucynta |
|---|
| Proprietary Name Suffix | Er |
|---|
| Non-Proprietary Name | Tapentadol Hydrochloride |
|---|
| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20110825 |
|---|
| Marketing Category Name | NDA |
|---|
| Application Number | NDA200533 |
|---|
| Manufacturer | Lake Erie Medical DBA Quality Care Products LLC |
|---|
| Substance Name | TAPENTADOL HYDROCHLORIDE |
|---|
| Strength | 100 |
|---|
| Strength Unit | mg/1 |
|---|
| Pharmacy Classes | Opioid Agonist [EPC],Opioid Agonists [MoA] |
|---|
| DEA Schedule | CII |
|---|