What is NDC 69097-967?

69097-967 is the product NDC for Sevelamer carbonate, Sevelamer carbonate 800 mg/1 tablet, film coated, listed with the FDA by Cipla USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Cipla USA Inc., NDC labeler code 69097. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Sevelamer carbonate NDC 69097-967 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69097-967Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69097-0967Add 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
69097-967-93	6909709679369097096793	270 TABLET, FILM COATED in 1 BOTTLE (69097-967-93)Marketed from Aug 8, 2019

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
Labeler: Cipla USA Inc.NDC labeler code 69097
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203860
Marketing start: Oct 26, 2017
Listing expires: Dec 31, 2027
Other FDA classes: Phosphate Chelating Activity (Mechanism)
Identifiers: Product ID 69097-967_444a974f-7f31-4b53-93c9-f5b9a251f711SPL ID 444a974f-7f31-4b53-93c9-f5b9a251f711SPL set ID 134f32c1-b5d5-44d0-9da5-85033e99320aRxCUI 749206UNII 9YCX42I8IUUPC 0369097967932
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

N469097096793 followed by a unit qualifier and the quantity

Package 69097-0967-93. 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 18, 2023.

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)

About NDC 69097-967

What is NDC 69097-967?: 69097-967 is the product NDC for Sevelamer carbonate, Sevelamer carbonate 800 mg/1 tablet, film coated, listed with the FDA by Cipla USA Inc.. 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?: Cipla USA Inc., NDC labeler code 69097. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Sevelamer Carbonate	Sevelamer carbonate 800 mg/1	Tablet, Film coatedOral	INSIGNAMEDEX LLC	87367-266	87367-0266-12
Sevelamer Carbonate	Sevelamer carbonate 800 mg/1	Tablet, Film coatedOral	Marp Pharma	85898-101	85898-0101-27
Sevelamer carbonate	Sevelamer carbonate 800 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	70710-2170	70710-2170-0370710-2170-0770710-2170-08
Sevelamer Carbonate	Sevelamer carbonate 800 mg/1	TabletOral	AiPing Pharmaceutical, Inc.	11788-116	11788-0116-07
Sevelamer Carbonate	Sevelamer carbonate 800 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-562	72789-0562-94
Sevelamer carbonate	Sevelamer carbonate 800 mg/1	Tablet, Film coatedOral	Navinta LLC	68475-010	68475-0010-0168475-0010-0268475-0010-03
Sevelamer Carbonate	Sevelamer carbonate 800 mg/1	Tablet, Film coatedOral	AvKARE	73190-014	73190-0014-27
Sevelamer Carbonate	Sevelamer carbonate 800 mg/1	Tablet, Film coatedOral	Westminster Pharmaceuticals, LLC	69367-423	69367-0423-27
Sevelamer Carbonate	Sevelamer carbonate 800 mg/1	Tablet, Film coatedOral	Shandong Xinhua Pharmaceutical Co., Ltd.	58624-5001	58624-5001-0258624-5001-04
Sevelamer Carbonate	Sevelamer carbonate .8 g/1	Powder, For suspensionOral	NorthStar RxLLC	72603-398	72603-0398-02

All 48 Sevelamer carbonate NDCs

Other NDCs under ANDA 203860

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

FDA NDC Directory listings under ANDA 203860
Product	Strength	Form · route	Labeler	Product NDC
Sevelamer carbonate	Sevelamer carbonate 800 mg/1	Tablet, Film coatedOral	Cipla USA Inc.	69097-893
Sevelamer carbonate	Sevelamer carbonate 800 mg/1	Tablet, Film coatedOral	Exelan Pharmaceuticals Inc.	76282-407
Sevelamer carbonate	Sevelamer carbonate 800 mg/1	Tablet, Film coatedOral	Exelan Pharmaceuticals Inc.	76282-664