sevelamer carbonate NDC 0115-1365

NDC codes

FDA NDC Directory

Product NDC (as listed)0115-1365Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00115-1365Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0115-1365-29	00115136529	90 PACKET in 1 CARTON (0115-1365-29) / 1 POWDER, FOR SUSPENSION in 1 PACKET (0115-1365-30)Marketed from Nov 20, 2020

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: Powder, For suspension
Route: Oral
Labeler: Amneal Pharmaceuticals of New York LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211316
Marketing start: Nov 20, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Phosphate Chelating Activity (Mechanism)
Identifiers: Product ID 0115-1365_b673720f-b62b-4afc-ac25-cb2ac4cf326fSPL ID b673720f-b62b-4afc-ac25-cb2ac4cf326fSPL set ID da5239fe-060b-4469-95ac-173adec43b9cRxCUI 861370, 861375UNII 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

N400115136529 followed by a unit qualifier and the quantity

Package 00115-1365-29. 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 Dec 31, 2020.

Indications (excerpt from the label)

Sevelamer carbonate for oral suspension is 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 for oral suspension 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 211316

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 211316
Product	Strength	Form · route	Labeler	Product NDC
sevelamer carbonate	Sevelamer carbonate 2400 mg/1	Powder, For suspensionOral	Amneal Pharmaceuticals of New York LLC	0115-1366