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] |