Prescription drug · ANDA
Sevelamer Carbonate NDC 71205-966
Sevelamer carbonate 800 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-966-67 | 71205096667 | 270 TABLET, FILM COATED in 1 BOTTLE (71205-966-67)Marketed from Jun 9, 2020 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200959
- Marketing start
- Marketing end
- Other FDA classes
- Phosphate Chelating Activity (Mechanism)
- Identifiers
- Product ID 71205-966_09aa537e-9f9c-4c0e-9ebf-59a4cf105ee4SPL ID 09aa537e-9f9c-4c0e-9ebf-59a4cf105ee4SPL set ID ee9da697-2d55-48e5-8e03-c64c8aaf1fb8RxCUI 749206UNII 9YCX42I8IUUPC 0371205966676
- 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
N471205096667followed by a unit qualifier and the quantityPackage 71205-0966-67. 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 tablets are indicated for the control of serum phosphorus in adults with chronic kidney disease (CKD) on dialysis. Pediatric use information is approved for Genzyme Corporation’s RENVELA ® (sevelamer carbonate) tablets and RENVELA ® (sevelamer carbonate) for oral suspension. However, due to Genzyme Corporation’s marketing exclusivity rights, these drug products are not labeled with that pediatric information . • Sevelamer carbonate tablets are a phosphate binder indicated for the control of serum phosphorus in adults with chronic kidney disease on dialysis. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 200959
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 | TWi Pharmaceuticals, Inc. | 24979-186 |
| Sevelamer Carbonate | Sevelamer carbonate 800 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-423 |
| Sevelamer Carbonate | Sevelamer carbonate 800 mg/1 | Tablet, Film coatedOral | AvKARE | 73190-014 |