Reprexain - hydrocodone bitartrate, ibuprofen
Navigation: NDC > Supplier starting with: H > HAWTHORN PHARMACEUTICALS, INC.| Field | Value |
|---|---|
| NDC Code: | 63717-901 |
| Proprietary Name: | Reprexain |
| Suffix: | |
| Non-Proprietary Name: | hydrocodone bitartrate, ibuprofen |
| Dosage Form: | TABLET, FILM COATED |
| Method: | ORAL |
| Original Marketing Date: | 16-12-2008 |
| Category Name: | ANDA |
| Application Number: | ANDA076642 |
| Labeler: | HAWTHORN PHARMACEUTICALS, INC. |
| Substance Name: | HYDROCODONE BITARTRATE; IBUPROFEN |
| Active Numerator Strength: | 5; 200 |
| Active Ingredient Unit: | mg/1; mg/1 |
| Pharm Classes: | Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] |
| DEA Schedule: | CIII |