What is NDC 59651-088?

59651-088 is the product NDC for Sevelamer Hydrochloride, Sevelamer hydrochloride 800 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Aurobindo Pharma Limited, NDC labeler code 59651. 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 Hydrochloride?

12 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Sevelamer Hydrochloride NDC 59651-088 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)59651-088Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59651-0088Add 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
59651-088-18	59651008818	180 TABLET, FILM COATED in 1 BOTTLE (59651-088-18)Marketed from Jul 11, 2023

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 Hydrochloride
Generic name (nonproprietary): sevelamer hydrochloride
Active ingredients: Sevelamer hydrochloride — 800 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Aurobindo Pharma LimitedNDC labeler code 59651
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212599
Marketing start: Jul 11, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Phosphate Chelating Activity (Mechanism)
Identifiers: Product ID 59651-088_7a6f6abf-8a91-423e-8f2f-de1b3a019e7bSPL ID 7a6f6abf-8a91-423e-8f2f-de1b3a019e7bSPL set ID d8729e42-dbbd-4954-9ce0-298743a15a06RxCUI 857216, 857224UNII GLS2PGI8QG
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

N459651008818 followed by a unit qualifier and the quantity

Package 59651-0088-18. 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 Jan 24, 2024.

Indications (excerpt from the label)

Sevelamer hydrochloride tablets are indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. The safety and efficacy of sevelamer hydrochloride tablets in CKD patients who are not on dialysis have not been studied. Sevelamer hydrochloride is a phosphate binder indicated for the control of serum phosphorus in patients 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 59651-088

What is NDC 59651-088?: 59651-088 is the product NDC for Sevelamer Hydrochloride, Sevelamer hydrochloride 800 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Sevelamer Hydrochloride.
What is the active ingredient?: Sevelamer hydrochloride.
Who is the labeler?: Aurobindo Pharma Limited, NDC labeler code 59651. 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 Hydrochloride?: 12 other product NDCs are listed under this name. See all Sevelamer Hydrochloride 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 Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Sevelamer Hydrochloride	Sevelamer hydrochloride 800 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	70710-2058	70710-2058-08
sevelamer hydrochloride	Sevelamer hydrochloride 800 mg/1	Tablet, Film coatedParenteral	Cardinal Health 107, LLC	55154-2647	55154-2647-00
sevelamer hydrochloride	Sevelamer hydrochloride 800 mg/1	Tablet, Film coatedParenteral	Major Pharmaceuticals	0904-7209	00904-7209-06
Sevelamer Hydrochloride	Sevelamer hydrochloride 400 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	59651-087	59651-0087-36
Sevelamer Hydrochloride	Sevelamer hydrochloride 400 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2500	72162-2500-02
Sevelamer Hydrochloride	Sevelamer hydrochloride 800 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2501	72162-2501-02
Sevelamer Hydrochloride	Sevelamer hydrochloride 400 mg/1	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-241	33342-0241-65
Sevelamer Hydrochloride	Sevelamer hydrochloride 800 mg/1	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-242	33342-0242-0733342-0242-57
Sevelamer hydrochloride	Sevelamer hydrochloride 800 mg/1	TabletOral	Lupin Pharmaceuticals, Inc.	70748-173	70748-0173-26
Sevelamer Hydrochloride	Sevelamer hydrochloride 800 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-449	60687-0449-01

All 13 Sevelamer Hydrochloride NDCs

Other NDCs under ANDA 212599

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

FDA NDC Directory listings under ANDA 212599
Product	Strength	Form · route	Labeler	Product NDC
Sevelamer Hydrochloride	Sevelamer hydrochloride 400 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	59651-087