NDC Code | 55700-555-60 |
Package Description | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55700-555-60) |
Product NDC | 55700-555 |
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 | 20170616 |
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 |