| Product NDC: | 0149-0478 |
| Proprietary Name: | ACTONEL |
| Non Proprietary Name: | RISEDRONATE SODIUM |
| Active Ingredient(s): | 150 mg/1 & nbsp; RISEDRONATE SODIUM |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0149-0478 |
| Labeler Name: | Warner Chilcott Pharmaceuticals Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA020835 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20080422 |
| Package NDC: | 0149-0478-06 |
| Package Description: | 24 CARTON in 1 CASE (0149-0478-06) > 1 DOSE PACK in 1 CARTON > 1 TRAY in 1 DOSE PACK > 1 TABLET, FILM COATED in 1 TRAY |
| NDC Code | 0149-0478-06 |
| Proprietary Name | ACTONEL |
| Package Description | 24 CARTON in 1 CASE (0149-0478-06) > 1 DOSE PACK in 1 CARTON > 1 TRAY in 1 DOSE PACK > 1 TABLET, FILM COATED in 1 TRAY |
| Product NDC | 0149-0478 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | RISEDRONATE SODIUM |
| Dosage Form Name | TABLET, FILM COATED |
| Route Name | ORAL |
| Start Marketing Date | 20080422 |
| Marketing Category Name | NDA |
| Labeler Name | Warner Chilcott Pharmaceuticals Inc. |
| Substance Name | RISEDRONATE SODIUM |
| Strength Number | 150 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] |