What is NDC 43598-478?

43598-478 is the product NDC for Sevelamer Carbonate for Oral Suspension, Sevelamer carbonate 800 mg/1 powder, for suspension, listed with the FDA by Dr. Reddys Laboratories Inc. It has 1 package NDC, shown above in 10- and 11-digit form.

Dr. Reddys Laboratories Inc, NDC labeler code 43598. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Sevelamer Carbonate for Oral Suspension?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Sevelamer Carbonate for Oral Suspension NDC 43598-478

NDC codes

FDA NDC Directory

Product NDC (as listed)43598-478Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43598-0478Add 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
43598-478-90	4359804789043598047890	90 PACKET in 1 CARTON (43598-478-90) / 1 POWDER, FOR SUSPENSION in 1 PACKET (43598-478-01)Marketed from Oct 25, 2018

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 for Oral Suspension
Generic name (nonproprietary): sevelamer carbonate for oral suspension
Active ingredients: Sevelamer carbonate — 800 mg/1
Dosage form: Powder, For suspension
Route: Oral
Labeler: Dr. Reddys Laboratories IncNDC labeler code 43598
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210464
Marketing start: Oct 25, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Phosphate Chelating Activity (Mechanism)
Identifiers: Product ID 43598-478_85e37025-d239-e504-38a0-c2db7ffa0100SPL ID 85e37025-d239-e504-38a0-c2db7ffa0100SPL set ID de172c3d-17eb-3489-35fb-370a0893b663RxCUI 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

N443598047890 followed by a unit qualifier and the quantity

Package 43598-0478-90. 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 May 20, 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 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)

About NDC 43598-478

What is NDC 43598-478?: 43598-478 is the product NDC for Sevelamer Carbonate for Oral Suspension, Sevelamer carbonate 800 mg/1 powder, for suspension, listed with the FDA by Dr. Reddys Laboratories Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Sevelamer Carbonate for Oral Suspension.
What is the active ingredient?: Sevelamer carbonate.
Who is the labeler?: Dr. Reddys Laboratories Inc, NDC labeler code 43598. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Sevelamer Carbonate for Oral Suspension?: 1 other product NDC are listed under this name. See all Sevelamer Carbonate for Oral Suspension NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Sevelamer Carbonate for Oral Suspension NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Sevelamer Carbonate for Oral Suspension	Sevelamer carbonate 2400 mg/1	Powder, For suspensionOral	Dr. Reddys Laboratories Inc	43598-479	43598-0479-90

Other NDCs under ANDA 210464

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

FDA NDC Directory listings under ANDA 210464
Product	Strength	Form · route	Labeler	Product NDC
Sevelamer Carbonate for Oral Suspension	Sevelamer carbonate 2400 mg/1	Powder, For suspensionOral	Dr. Reddys Laboratories Inc	43598-479