| NDC Code |
50991-578-01 |
| Proprietary Name |
IBUDONE |
| Package Description |
100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50991-578-01) |
| Product NDC |
50991-578 |
| Product Type Name |
HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name |
hydrocodone bitartrate and ibuprofen |
| Dosage Form Name |
TABLET, FILM COATED |
| Route Name |
ORAL |
| Start Marketing Date |
20061106 |
| Marketing Category Name |
ANDA |
| Labeler Name |
Poly Pharmaceuticals |
| Substance Name |
HYDROCODONE BITARTRATE; IBUPROFEN |
| Strength Number |
5; 200 |
| Strength Unit |
mg/1; mg/1 |
| Pharmaceutical Classes |
Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] |