Renvela
- Product NDC
- 58468-0133
- 11-digit product format
- 584680133
- Labeler code
- 58468
- Product ID
- 58468-0133_cb4453a2-c47b-4352-839f-f022ac67368e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SEVELAMER CARBONATE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Genzyme Corporation
- Application
- NDA022127
- Marketing category
- NDA
- Marketing start
- 2009-08-12
- Substance
- SEVELAMER CARBONATE
- Active strength
- 800 mg/1
- Pharmacologic classes
- Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 9YCX42I8IU | SEVELAMER CARBONATE | 845273-93-0 | SEVELAMER CARBONATE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 58468-0133-1 | 58468013301 | 270 TABLET, FILM COATED in 1 BOTTLE (58468-0133-1) | 2023-07-14 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Renvela | Genzyme Corporation | Reed-Lane, Inc. | HVL Pharma UK Limited | Eurofins Biopharma Product Testing Ireland Limited | Rovi Pharma Industrial Services SA | Sanofi Winthrop Industrie | Genzyme Ireland Limited | 2025-11-25 | HUMAN PRESCRIPTION DRUG LABEL | 47 |