Prescription drug · ANDA
Sevelamer Carbonate NDC 0615-8239
Sevelamer carbonate 800 mg/1 · Tablet, Film coated · Oral · NCS HealthCare of KY, LLC dba Vangard Labs
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0615-8239-05 | 00615823905 | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8239-05)Marketed from Jul 15, 2024 | |
| 0615-8239-39 | 00615823939 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8239-39)Marketed from Nov 6, 2018 |
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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207179
- Marketing start
- Listing expires
- Other FDA classes
- Phosphate Chelating Activity (Mechanism)
- Identifiers
- Product ID 0615-8239_058c3f14-09d3-4075-a066-6294fc7139c4SPL ID 058c3f14-09d3-4075-a066-6294fc7139c4SPL set ID ccfde4dd-b258-4baf-995b-a24bed8c84d7RxCUI 749206UNII 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
N400615823905followed by a unit qualifier and the quantityPackage 00615-8239-05. 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 and children 6 years of age and older with chronic kidney disease (CKD) on dialysis. Sevelamer carbonate tablets are 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 ANDA 207179
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 | ATLANTIC BIOLOGICALS CORP. | 17856-0921 |
| Sevelamer Carbonate | Sevelamer carbonate 800 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-8188 |
| Sevelamer Carbonate | Sevelamer carbonate 800 mg/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 16714-814 |
| Sevelamer Carbonate | Sevelamer carbonate 800 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-328 |
| Sevelamer Carbonate | Sevelamer carbonate 800 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-921 |