Prescription drug · ANDA
sevelamer hydrochloride NDC 55154-2647
Sevelamer hydrochloride 800 mg/1 · Tablet, Film coated · Parenteral · Cardinal Health 107, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55154-2647-0 | 55154264700 | 10 BLISTER PACK in 1 BAG (55154-2647-0) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Feb 25, 2025 |
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 hydrochloride
- Generic name (nonproprietary)
- sevelamer hydrochloride
- Active ingredients
- Sevelamer hydrochloride — 800 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Parenteral
- Labeler
- Cardinal Health 107, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204724
- Marketing start
- Listing expires
- Other FDA classes
- Phosphate Chelating Activity (Mechanism)
- Identifiers
- Product ID 55154-2647_cd703ad5-7d31-462e-971e-44bd794498baSPL ID cd703ad5-7d31-462e-971e-44bd794498baSPL set ID c13532a7-4c56-4084-839d-3dcfd4dc30f8RxCUI 857224UNII GLS2PGI8QGUPC 0055154264709
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N455154264700followed by a unit qualifier and the quantityPackage 55154-2647-00. 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)
1. INDICATIONS AND USAGE Sevelamer hydrochloride tablets are indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. The safety and efficacy of sevelamer hydrochloride tablets in CKD patients who are not on dialysis have not been studied. • Sevelamer hydrochloride tablets are a phosphate binder indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204724
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 hydrochloride | Sevelamer hydrochloride 800 mg/1 | Tablet, Film coatedParenteral | Major Pharmaceuticals | 0904-7209 |
| Sevelamer Hydrochloride | Sevelamer hydrochloride 800 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-449 |
| sevelamer hydrochloride | Sevelamer hydrochloride 400 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc., USA | 68462-446 |
| sevelamer hydrochloride | Sevelamer hydrochloride 800 mg/1 | Tablet, Film coatedParenteral | Glenmark Pharmaceuticals Inc., USA | 68462-447 |