NDC codes

FDA NDC Directory
Product NDC (as listed)64380-880Labeler and product segments. Claims need a package NDC.
Product NDC at billing width64380-0880Add 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
64380-880-80643800880806438008808090 PACKET in 1 CARTON (64380-880-80) / 800 mg in 1 PACKET (64380-880-00)Marketed from Feb 2, 2024

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/930mg
Dosage form
For suspension
Route
Oral
Labeler
Strides Pharma Science LimitedNDC labeler code 64380
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211917
Marketing start
Listing expires
Other FDA classes
Phosphate Chelating Activity (Mechanism)
Identifiers
Product ID 64380-880_a5197e88-8ea0-4312-890a-5d4d33ec80b3SPL ID a5197e88-8ea0-4312-890a-5d4d33ec80b3SPL set ID c17bff97-8347-43f8-822e-1cb9736562b6RxCUI 861370, 861375UNII 9YCX42I8IUUPC 0364380880806, 0364380881803
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

N464380088080 followed by a unit qualifier and the quantity

Package 64380-0880-80. 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 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)

About NDC 64380-880

What is NDC 64380-880?
64380-880 is the product NDC for Sevelamer Carbonate, Sevelamer carbonate 800 mg/930mg for suspension, listed with the FDA by Strides Pharma Science Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Sevelamer Carbonate.
What is the active ingredient?
Sevelamer carbonate.
Who is the labeler?
Strides Pharma Science Limited, NDC labeler code 64380. 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?
47 other product NDCs are listed under this name. See all Sevelamer Carbonate 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 NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Sevelamer CarbonateSevelamer carbonate 800 mg/1Tablet, Film coatedOralINSIGNAMEDEX LLC87367-26687367-0266-12
Sevelamer CarbonateSevelamer carbonate 800 mg/1Tablet, Film coatedOralMarp Pharma85898-10185898-0101-27
Sevelamer carbonateSevelamer carbonate 800 mg/1Tablet, Film coatedOralZydus Pharmaceuticals USA Inc.70710-217070710-2170-0370710-2170-0770710-2170-08
Sevelamer CarbonateSevelamer carbonate 800 mg/1TabletOralAiPing Pharmaceutical, Inc.11788-11611788-0116-07
Sevelamer CarbonateSevelamer carbonate 800 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-56272789-0562-94
Sevelamer carbonateSevelamer carbonate 800 mg/1Tablet, Film coatedOralNavinta LLC68475-01068475-0010-0168475-0010-0268475-0010-03
Sevelamer CarbonateSevelamer carbonate 800 mg/1Tablet, Film coatedOralAvKARE73190-01473190-0014-27
Sevelamer CarbonateSevelamer carbonate 800 mg/1Tablet, Film coatedOralWestminster Pharmaceuticals, LLC69367-42369367-0423-27
Sevelamer CarbonateSevelamer carbonate 800 mg/1Tablet, Film coatedOralShandong Xinhua Pharmaceutical Co., Ltd.58624-500158624-5001-0258624-5001-04
Sevelamer CarbonateSevelamer carbonate .8 g/1Powder, For suspensionOralNorthStar RxLLC72603-39872603-0398-02

All 48 Sevelamer Carbonate NDCs

Other NDCs under ANDA 211917

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

FDA NDC Directory listings under ANDA 211917
ProductStrengthForm · routeLabelerProduct NDC
Sevelamer CarbonateSevelamer carbonate 2400 mg/2790mgFor suspensionOralStrides Pharma Science Limited64380-881

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in