Prescription drug · ANDA
Sevelamer carbonate NDC 69097-893
Sevelamer carbonate 800 mg/1 · Tablet, Film coated · Oral · Cipla USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-893-93 | 69097089393 | 270 TABLET, FILM COATED in 1 BOTTLE (69097-893-93)Marketed from Oct 26, 2017 |
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
- Cipla USA Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203860
- Marketing start
- Listing expires
- Other FDA classes
- Phosphate Chelating Activity (Mechanism)
- Identifiers
- Product ID 69097-893_b4a439b7-08e8-4d1b-abea-f7976010d323SPL ID b4a439b7-08e8-4d1b-abea-f7976010d323SPL set ID f63450bd-d075-4810-a277-e8bc41e4a5afRxCUI 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
N469097089393followed by a unit qualifier and the quantityPackage 69097-0893-93. 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 is 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. However, due to Genzyme Corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information Sevelamer carbonate is 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 203860
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 | Exelan Pharmaceuticals Inc. | 76282-407 |
| Sevelamer carbonate | Sevelamer carbonate 800 mg/1 | Tablet, Film coatedOral | Exelan Pharmaceuticals Inc. | 76282-664 |
| Sevelamer carbonate | Sevelamer carbonate 800 mg/1 | Tablet, Film coatedOral | Cipla USA Inc. | 69097-967 |