| NDC Code: |
16590-878 |
| 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: |
STAT RX USA |
| 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 |
