Prescription drug · ANDA
Sevelamer Hydrochloride NDC 60687-449
Sevelamer hydrochloride 800 mg/1 · Tablet, Film coated · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60687-449-01 | 60687044901 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-449-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-449-11)Marketed from Jan 22, 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 Hydrochloride
- Generic name (nonproprietary)
- sevelamer hydrochloride
- Active ingredients
- Sevelamer hydrochloride — 800 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- American Health Packaging
- 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 60687-449_5514eaac-2197-947d-e063-6294a90a4c5dSPL ID 5514eaac-2197-947d-e063-6294a90a4c5dSPL set ID 8830526f-d957-423e-84ea-e4d79346948bRxCUI 857224UNII GLS2PGI8QG
- 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
N460687044901followed by a unit qualifier and the quantityPackage 60687-0449-01. 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 coatedParenteral | Cardinal Health 107, LLC | 55154-2647 |
| 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 |