Prescription drug · NDA
Renvela (Sevelamer carbonate) NDC 58468-0131
Sevelamer carbonate 2400 mg/1 · Powder, For suspension · Oral · Genzyme Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58468-0131-2 | 5846801310258468013102 | 90 PACKET in 1 CARTON (58468-0131-2) / 1 POWDER, FOR SUSPENSION in 1 PACKET (58468-0131-1)Marketed from Aug 12, 2009 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Renvela
- Generic name (nonproprietary)
- sevelamer carbonate
- Active ingredients
- Sevelamer carbonate — 2400 mg/1
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- Genzyme CorporationNDC labeler code 58468
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022318
- Marketing start
- Listing expires
- Other FDA classes
- Phosphate Chelating Activity (Mechanism)
- Identifiers
- Product ID 58468-0131_cb4453a2-c47b-4352-839f-f022ac67368eSPL ID cb4453a2-c47b-4352-839f-f022ac67368eSPL set ID e6328460-a57b-450b-a48c-6dcd4b476360RxCUI 749206, 749210, 861370, 861373, 861375, 861377UNII 9YCX42I8IU
- Pharmacologic class
- Phosphate Binder
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N458468013102followed by a unit qualifier and the quantityPackage 58468-0131-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Renvela ® (sevelamer carbonate) is indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis. Renvela ® is a phosphate binder indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease on dialysis. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 58468-0131
- What is NDC 58468-0131?
- 58468-0131 is the product NDC for Renvela (sevelamer carbonate), Sevelamer carbonate 2400 mg/1 powder, for suspension, listed with the FDA by Genzyme Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Renvela (Sevelamer carbonate).
- What is the active ingredient?
- Sevelamer carbonate.
- Who is the labeler?
- Genzyme Corporation, NDC labeler code 58468. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Renvela?
- 2 other product NDCs are listed under this name. See all Renvela NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Renvela products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Renvelasevelamer carbonate | Sevelamer carbonate 800 mg/1 | Powder, For suspensionOral | Genzyme Corporation | 58468-0132 | 58468-0132-02 |
| Renvelasevelamer carbonate | Sevelamer carbonate 800 mg/1 | Tablet, Film coatedOral | Genzyme Corporation | 58468-0133 | 58468-0133-01 |
Other NDCs under NDA 022318
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Renvelasevelamer carbonate | Sevelamer carbonate 800 mg/1 | Powder, For suspensionOral | Genzyme Corporation | 58468-0132 |
| Sevelamer Carbonate | Sevelamer carbonate .8 g/1 | Powder, For suspensionOral | Sanofi-Aventis U.S. LLC | 0955-1052 |
| Sevelamer Carbonate | Sevelamer carbonate 2.4 g/1 | Powder, For suspensionOral | Sanofi-Aventis U.S. LLC | 0955-1054 |