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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Renvela
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SEVELAMER CARBONATE | 800 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9YCX42I8IU |
| Rxcui | 749206, 749210, 861370, 861373, 861375, 861377 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58468-0133-1 | Renvela | 270 in 1 BOTTLE | TABLET, FILM COATED | 270 | | 47 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SEVELAMER CARBONATE | ACTIVE INGREDIENT | 9YCX42I8IU | RENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED RENVELA (SEVELAMER CARBONATE) POWDER, FOR SUSPENSION [GENZYME CORPORATION] | 13 | |
| SEVELAMER | ACTIVE MOIETY | 941N5DUU5C | RENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED RENVELA (SEVELAMER CARBONATE) POWDER, FOR SUSPENSION [GENZYME CORPORATION] | 13 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | RENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED RENVELA (SEVELAMER CARBONATE) POWDER, FOR SUSPENSION [GENZYME CORPORATION] | 13 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | RENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED RENVELA (SEVELAMER CARBONATE) POWDER, FOR SUSPENSION [GENZYME CORPORATION] | 13 | |
| HYPROMELLOSE 2910 (15 MPA.S) | INACTIVE INGREDIENT | 36SFW2JZ0W | RENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED RENVELA (SEVELAMER CARBONATE) POWDER, FOR SUSPENSION [GENZYME CORPORATION] | 13 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | RENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED RENVELA (SEVELAMER CARBONATE) POWDER, FOR SUSPENSION [GENZYME CORPORATION] | 13 | |
| PROPYLENE GLYCOL ALGINATE | INACTIVE INGREDIENT | 26CD3J2R0C | RENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED RENVELA (SEVELAMER CARBONATE) POWDER, FOR SUSPENSION [GENZYME CORPORATION] | 13 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | RENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED RENVELA (SEVELAMER CARBONATE) POWDER, FOR SUSPENSION [GENZYME CORPORATION] | 13 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | RENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED RENVELA (SEVELAMER CARBONATE) POWDER, FOR SUSPENSION [GENZYME CORPORATION] | 13 | |
| ZINC STEARATE | INACTIVE INGREDIENT | H92E6QA4FV | RENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED RENVELA (SEVELAMER CARBONATE) POWDER, FOR SUSPENSION [GENZYME CORPORATION] | 13 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58468-0133 | RENVELA (SEVELAMER CARBONATE) POWDER, FOR SUSPENSION RENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED [GENZYME CORPORATION] | 43 | Current NDC, 1 package rows | 20230926_e6328460-a57b-450b-a48c-6dcd4b476360.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| 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 | Current |