Prescription drug · NDA AUTHORIZED GENERIC
Sevelamer Carbonate NDC 0955-1057
Sevelamer carbonate 800 mg/1 · Tablet, Film coated · Oral · Sanofi-Aventis U.S. LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0955-1057-30 | 00955105730 | 270 TABLET, FILM COATED in 1 BOTTLE (0955-1057-30)Marketed from Jul 14, 2023 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Sevelamer Carbonate
- Generic name (nonproprietary)
- sevelamer carbonate
- Active ingredients
- Sevelamer carbonate — 800 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Sanofi-Aventis U.S. LLC
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 022127
- Marketing start
- Listing expires
- Other FDA classes
- Phosphate Chelating Activity (Mechanism)
- Identifiers
- Product ID 0955-1057_42bdb389-5550-487c-aed2-c4e3afd239c8SPL ID 42bdb389-5550-487c-aed2-c4e3afd239c8SPL set ID 3abc32fe-1bfc-4759-8f7c-36095e221b06RxCUI 749206, 861370, 861375UNII 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
N400955105730followed by a unit qualifier and the quantityPackage 00955-1057-30. 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)
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. Sevelamer carbonate 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.
Other NDCs under NDA 022127
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 |
|---|---|---|---|---|
| Sevelamer Carbonate | Sevelamer carbonate 800 mg/1 | Tablet, Film coatedOral | Sanofi-Aventis U.S. LLC | 0955-1050 |
| Renvelasevelamer carbonate | Sevelamer carbonate 800 mg/1 | Tablet, Film coatedOral | Genzyme Corporation | 58468-0133 |