Prescription drug · ANDA
Sevelamer Carbonate NDC 55154-3358
Sevelamer carbonate 800 mg/1 · Tablet, Film coated · Oral · Cardinal Health 107, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55154-3358-0 | 55154335800 | 10 BLISTER PACK in 1 BAG (55154-3358-0) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Sep 29, 2017 |
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)
- Sevelamer Carbonate
- Generic name (nonproprietary)
- sevelamer carbonate
- Active ingredients
- Sevelamer carbonate — 800 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Cardinal Health 107, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206094
- Marketing start
- Marketing end
- Other FDA classes
- Phosphate Chelating Activity (Mechanism)
- Identifiers
- Product ID 55154-3358_d32d8ace-7628-4b19-805b-83541f82ce35SPL ID d32d8ace-7628-4b19-805b-83541f82ce35SPL set ID 65184825-adce-480e-a4c3-b21e37656cf4RxCUI 749206UNII 9YCX42I8IUUPC 0055154335805
- 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
N455154335800followed by a unit qualifier and the quantityPackage 55154-3358-00. 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 tablet 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 ANDA 206094
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 | DR. REDDY'S LABORATORIES LIMITED | 55111-789 |
| Sevelamer Carbonate | Sevelamer carbonate 800 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-706 |
| Sevelamer Carbonate | Sevelamer carbonate 800 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6707 |