| Product NDC: | 58468-0131 |
| Proprietary Name: | Renvela |
| Non Proprietary Name: | SEVELAMER CARBONATE |
| Active Ingredient(s): | 2400 mg/1 & nbsp; SEVELAMER CARBONATE |
| Administration Route(s): | ORAL |
| Dosage Form(s): | POWDER, FOR SUSPENSION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 58468-0131 |
| Labeler Name: | Genzyme Corporation |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA022318 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20090812 |
| Package NDC: | 58468-0131-4 |
| Package Description: | 90 PACKET in 1 CARTON (58468-0131-4) > 1 POWDER, FOR SUSPENSION in 1 PACKET (58468-0131-3) |
| NDC Code | 58468-0131-4 |
| Proprietary Name | Renvela |
| Package Description | 90 PACKET in 1 CARTON (58468-0131-4) > 1 POWDER, FOR SUSPENSION in 1 PACKET (58468-0131-3) |
| Product NDC | 58468-0131 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | SEVELAMER CARBONATE |
| Dosage Form Name | POWDER, FOR SUSPENSION |
| Route Name | ORAL |
| Start Marketing Date | 20090812 |
| Marketing Category Name | NDA |
| Labeler Name | Genzyme Corporation |
| Substance Name | SEVELAMER CARBONATE |
| Strength Number | 2400 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] |