| NDC Code | 0430-0478-95 |
| Package Description | 36 DOSE PACK in 1 CARTON (0430-0478-95) > 1 TRAY in 1 DOSE PACK > 1 TABLET, FILM COATED in 1 TRAY |
| Product NDC | 0430-0478 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Actonel |
| Non-Proprietary Name | Risedronate Sodium |
| Dosage Form | TABLET, FILM COATED |
| Usage | ORAL |
| Start Marketing Date | 20080422 |
| Marketing Category Name | NDA |
| Application Number | NDA020835 |
| Manufacturer | Warner Chilcott (US), LLC |
| Substance Name | RISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE |
| Strength | 129; 21 |
| Strength Unit | mg/1; mg/1 |
| Pharmacy Classes | Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient],Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] |