NDC 58468-0131
Renvela
Sevelamer Carbonate
Renvela is a Oral Powder, For Suspension in the Human Prescription Drug category. It is labeled and distributed by Genzyme Corporation. The primary component is Sevelamer Carbonate.
| Product ID | 58468-0131_0bb21936-57aa-481a-a51c-a20090f4d983 |
| NDC | 58468-0131 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Renvela |
| Generic Name | Sevelamer Carbonate |
| Dosage Form | Powder, For Suspension |
| Route of Administration | ORAL |
| Marketing Start Date | 2009-08-12 |
| Marketing Category | NDA / NDA |
| Application Number | NDA022318 |
| Labeler Name | Genzyme Corporation |
| Substance Name | SEVELAMER CARBONATE |
| Active Ingredient Strength | 2400 mg/1 |
| Pharm Classes | Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
Packaging
NDC 58468-0131-2
90 PACKET in 1 CARTON (58468-0131-2) > 1 POWDER, FOR SUSPENSION in 1 PACKET (58468-0131-1)
| Marketing Start Date | 2009-08-12 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 58468-0131-4 [58468013104]
Renvela POWDER, FOR SUSPENSION
| Marketing Category | NDA |
| Application Number | NDA022318 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2009-08-12 |
NDC 58468-0131-2 [58468013102]
Renvela POWDER, FOR SUSPENSION
| Marketing Category | NDA |
| Application Number | NDA022318 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2009-08-12 |
NDC 58468-0131-1 [58468013101]
Renvela POWDER, FOR SUSPENSION
| Marketing Category | NDA |
| Application Number | NDA022318 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2009-08-12 |
NDC 58468-0131-3 [58468013103]
Renvela POWDER, FOR SUSPENSION
| Marketing Category | NDA |
| Application Number | NDA022318 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2009-08-12 |
NDC 58468-0131-5 [58468013105]
Renvela POWDER, FOR SUSPENSION
| Marketing Category | NDA |
| Application Number | NDA022318 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2009-08-12 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| SEVELAMER CARBONATE | 2400 mg/1 |
OpenFDA Data
| SPL SET ID: | e6328460-a57b-450b-a48c-6dcd4b476360 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Phosphate Binder [EPC]
- Phosphate Chelating Activity [MoA]
Medicade Reported Pricing
58468013102 RENVELA 2.4 GM POWDER PACKET
Pricing Unit: EA | Drug Type:
58468013101 RENVELA 2.4 GM POWDER PACKET
Pricing Unit: EA | Drug Type:
NDC Crossover Matching brand name "Renvela" or generic name "Sevelamer Carbonate"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 17856-0130 | Renvela | SEVELAMER CARBONATE |
| 68151-5113 | Renvela | Renvela |
| 58468-0132 | Renvela | Renvela |
| 58468-0131 | Renvela | Renvela |
| 58468-0130 | Renvela | Renvela |
| 0115-1309 | Sevelamer Carbonate | Sevelamer Carbonate |
| 0115-1365 | sevelamer carbonate | sevelamer carbonate |
| 0115-1366 | sevelamer carbonate | sevelamer carbonate |
| 0615-8239 | Sevelamer Carbonate | Sevelamer Carbonate |
| 0904-6707 | Sevelamer Carbonate | Sevelamer Carbonate |
| 0955-1050 | Sevelamer Carbonate | Sevelamer Carbonate |
| 0955-1052 | Sevelamer Carbonate | Sevelamer Carbonate |
| 0955-1054 | Sevelamer Carbonate | Sevelamer Carbonate |
| 10135-660 | Sevelamer Carbonate | Sevelamer Carbonate |
| 16571-739 | Sevelamer carbonate | Sevelamer carbonate |
| 16714-814 | Sevelamer Carbonate | Sevelamer Carbonate |
| 17856-0058 | Sevelamer Carbonate | Sevelamer Carbonate |
| 17856-0921 | Sevelamer Carbonate | Sevelamer Carbonate |
| 24979-186 | Sevelamer Carbonate | Sevelamer Carbonate |
| 42291-763 | Sevelamer Carbonate | Sevelamer Carbonate |
| 42571-378 | SEVELAMER CARBONATE | SEVELAMER CARBONATE |
Trademark Results [Renvela]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RENVELA 78674340 3326463 Live/Registered |
GENZYME CORPORATION 2005-07-20 |
 RENVELA 77228109 3517569 Dead/Cancelled |
Genzyme Corporation 2007-07-12 |
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