NDC Code | 53746-117-01 |
Package Description | 100 TABLET in 1 BOTTLE (53746-117-01) |
Product NDC | 53746-117 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Hydrocodone Bitartrate And Ibuprofen |
Non-Proprietary Name | Hydrocodone Bitartrate And Ibuprofen |
Dosage Form | TABLET |
Usage | ORAL |
Start Marketing Date | 20100218 |
Marketing Category Name | ANDA |
Application Number | ANDA076642 |
Manufacturer | Amneal Pharmaceuticals of New York LLC |
Substance Name | HYDROCODONE BITARTRATE; IBUPROFEN |
Strength | 10; 200 |
Strength Unit | mg/1; mg/1 |
Pharmacy Classes | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Opioid Agonist [EPC], Opioid Agonists [MoA] |
DEA Schedule | CII |