NDC codes

FDA NDC Directory
Product NDC (as listed)55111-789Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55111-0789Add 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
55111-789-115511107891125 BLISTER PACK in 1 CARTON (55111-789-11) / 4 TABLET, FILM COATED in 1 BLISTER PACK (55111-789-48)Marketed from Dec 12, 2018
55111-789-2755111078927270 TABLET, FILM COATED in 1 BOTTLE (55111-789-27)Marketed from Sep 29, 2017
55111-789-305511107893030 TABLET, FILM COATED in 1 BOTTLE (55111-789-30)Marketed from Sep 29, 2017
55111-789-905511107899090 TABLET, FILM COATED in 1 BOTTLE (55111-789-90)Marketed from Sep 29, 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
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206094
Marketing start
Listing expires
Other FDA classes
Phosphate Chelating Activity (Mechanism)
Identifiers
Product ID 55111-789_f4b7a1eb-7592-27f3-1316-50b7d2538cd1SPL ID f4b7a1eb-7592-27f3-1316-50b7d2538cd1SPL set ID 0085356d-5fec-3cce-2bd3-108be70e515dRxCUI 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

N455111078911 followed by a unit qualifier and the quantity

Package 55111-0789-11. 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 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 tablet 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 206094

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

FDA NDC Directory listings under ANDA 206094
ProductStrengthForm · routeLabelerProduct NDC
Sevelamer CarbonateSevelamer carbonate 800 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-3358
Sevelamer CarbonateSevelamer carbonate 800 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.51407-706
Sevelamer CarbonateSevelamer carbonate 800 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6707

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