| NDC Code | 63717-902-99 |
|---|
| Package Description | 1 TABLET, FILM COATED in 1 PACKET (63717-902-99) |
|---|
| Product NDC | 63717-902 |
|---|
| 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 | Hawthorn Pharmaceuticals, Inc. |
|---|
| Substance Name | HYDROCODONE BITARTRATE; IBUPROFEN |
|---|
| Strength | 10; 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 |
|---|