NDC codes

FDA NDC Directory
Product NDC (as listed)0955-1057Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00955-1057Add 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 NDC11-digit (billing)PackageCopy
0955-1057-3000955105730270 TABLET, FILM COATED in 1 BOTTLE (0955-1057-30)Marketed from Jul 14, 2023

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
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 022127
Marketing start
Listing expires
Other FDA classes
Phosphate Chelating Activity (Mechanism)
Identifiers
Product ID 0955-1057_42bdb389-5550-487c-aed2-c4e3afd239c8SPL ID 42bdb389-5550-487c-aed2-c4e3afd239c8SPL set ID 3abc32fe-1bfc-4759-8f7c-36095e221b06RxCUI 749206, 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

N400955105730 followed by a unit qualifier and the quantity

Package 00955-1057-30. 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 and children 6 years of age and older with chronic kidney disease (CKD) on dialysis. Sevelamer carbonate 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 NDA 022127

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

FDA NDC Directory listings under NDA 022127
ProductStrengthForm · routeLabelerProduct NDC
Sevelamer CarbonateSevelamer carbonate 800 mg/1Tablet, Film coatedOralSanofi-Aventis U.S. LLC0955-1050
Renvelasevelamer carbonateSevelamer carbonate 800 mg/1Tablet, Film coatedOralGenzyme Corporation58468-0133

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