| NDC Code | 16590-878-30 |
| Package Description | 30 TABLET, FILM COATED in 1 BOTTLE (16590-878-30) |
| Product NDC | 16590-878 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Reprexain |
| Non-Proprietary Name | Hydrocodone Bitartrate, Ibuprofen |
| Dosage Form | TABLET, FILM COATED |
| Usage | ORAL |
| Start Marketing Date | 20081216 |
| Marketing Category Name | ANDA |
| Application Number | ANDA076642 |
| Manufacturer | Stat Rx USA |
| Substance Name | HYDROCODONE BITARTRATE; IBUPROFEN |
| Strength | 5; 200 |
| Strength Unit | mg/1; mg/1 |
| Pharmacy Classes | Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] |
| DEA Schedule | CIII |