NDC Code | 23710-901-01 |
Package Description | 100 TABLET, FILM COATED in 1 BOTTLE (23710-901-01) |
Product NDC | 23710-901 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Reprexain |
Non-Proprietary Name | Hydrocodone Bitartrate And Ibuprofen |
Dosage Form | TABLET, FILM COATED |
Usage | ORAL |
Start Marketing Date | 20100218 |
Marketing Category Name | ANDA |
Application Number | ANDA076642 |
Manufacturer | Quinnova Pharmaceuticals, LLC |
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 |