Sevelamer Carbonate NDC 65162-058

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-058Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0058Add 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
65162-058-03	65162005803	30 TABLET, FILM COATED in 1 BOTTLE (65162-058-03)Marketed from Jul 13, 2023
65162-058-06	65162005806	60 TABLET, FILM COATED in 1 BOTTLE (65162-058-06)Marketed from Jul 13, 2023
65162-058-09	65162005809	90 TABLET, FILM COATED in 1 BOTTLE (65162-058-09)Marketed from Nov 28, 2017
65162-058-11	65162005811	1000 TABLET, FILM COATED in 1 BOTTLE (65162-058-11)Marketed from Nov 28, 2017
65162-058-27	65162005827	270 TABLET, FILM COATED in 1 BOTTLE (65162-058-27)Marketed from Nov 28, 2017
65162-058-50	65162005850	500 TABLET, FILM COATED in 1 BOTTLE (65162-058-50)Marketed from Nov 28, 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: Amneal Pharmaceuticals LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207288
Marketing start: Nov 28, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Phosphate Chelating Activity (Mechanism)
Identifiers: Product ID 65162-058_53f81fb7-7bbc-430f-a2e4-841b58e2cb7cSPL ID 53f81fb7-7bbc-430f-a2e4-841b58e2cb7cSPL set ID 94d8cfb1-ff2a-4956-8954-17635ac505d9RxCUI 749206UNII 9YCX42I8IUUPC 0365162058277
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

N465162005803 followed by a unit qualifier and the quantity

Package 65162-0058-03. 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 Nov 5, 2023.

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 tablets are 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 207288

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

FDA NDC Directory listings under ANDA 207288
Product	Strength	Form · route	Labeler	Product NDC
Sevelamer Carbonate	Sevelamer carbonate 800 mg/1	Tablet, Film coatedOral	AvPAK	50268-720
Sevelamer Carbonate	Sevelamer carbonate 800 mg/1	Tablet, Film coatedOral	Precision Dose, Inc.	68094-034