| Product NDC: | 16590-889 |
| Proprietary Name: | NUCYNTA |
| Non Proprietary Name: | TAPENTADOL HYDROCHLORIDE |
| Active Ingredient(s): | 75 mg/1 & nbsp; TAPENTADOL HYDROCHLORIDE |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 16590-889 |
| Labeler Name: | STAT RX USA LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA022304 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20090601 |
| Package NDC: | 16590-889-72 |
| Package Description: | 120 TABLET, FILM COATED in 1 BOTTLE (16590-889-72) |
| NDC Code | 16590-889-72 |
| Proprietary Name | NUCYNTA |
| Package Description | 120 TABLET, FILM COATED in 1 BOTTLE (16590-889-72) |
| Product NDC | 16590-889 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | TAPENTADOL HYDROCHLORIDE |
| Dosage Form Name | TABLET, FILM COATED |
| Route Name | ORAL |
| Start Marketing Date | 20090601 |
| Marketing Category Name | NDA |
| Labeler Name | STAT RX USA LLC |
| Substance Name | TAPENTADOL HYDROCHLORIDE |
| Strength Number | 75 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Opioid Agonist [EPC],Opioid Agonists [MoA] |