What is NDC 69097-862?

69097-862 is the product NDC for Calcium Acetate, Calcium acetate 667 mg/1 capsule, listed with the FDA by Cipla USA Inc.,. It has 2 package NDCs, 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 Calcium Acetate?

21 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Calcium Acetate NDC 69097-862 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69097-862Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69097-0862Add 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
69097-862-03	6909708620369097086203	60 CAPSULE in 1 BOTTLE (69097-862-03)Marketed from Jul 26, 2016
69097-862-83	6909708628369097086283	200 CAPSULE in 1 BOTTLE (69097-862-83)Marketed from Jul 26, 2016

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): Calcium Acetate
Generic name (nonproprietary): calcium acetate
Active ingredients: Calcium acetate — 667 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Cipla USA Inc.,NDC labeler code 69097
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203135
Marketing start: Jul 26, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Calcium (Chemical structure)Divalent (Chemical structure)Increased Coagulation Factor Activity (Physiologic effect)
Identifiers: Product ID 69097-862_7749772b-1a26-4b2e-b97d-3ee29611d035SPL ID 7749772b-1a26-4b2e-b97d-3ee29611d035SPL set ID 000c044a-12ef-4484-942e-99552b777d58RxCUI 359296UNII Y882YXF34X
Pharmacologic class: Blood Coagulation Factor

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

N469097086203 followed by a unit qualifier and the quantity

Package 69097-0862-03. 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 Jun 1, 2021.

Indications (excerpt from the label)

Calcium acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD). Calcium acetate is a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69097-862

What is NDC 69097-862?: 69097-862 is the product NDC for Calcium Acetate, Calcium acetate 667 mg/1 capsule, listed with the FDA by Cipla USA Inc.,. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Calcium Acetate.
What is the active ingredient?: Calcium acetate.
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 Calcium Acetate?: 21 other product NDCs are listed under this name. See all Calcium Acetate 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 Calcium Acetate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Calcium Acetate	Calcium acetate 667 mg/1	CapsuleOral	American Health Packaging	60687-589	60687-0589-65
Calcium Acetate	Calcium acetate 667 mg/1	CapsuleOral	AvPAK	50268-203	50268-0203-15
Calcium Acetate	Calcium acetate 667 mg/1	CapsuleOral	Westminster Pharmaceuticals, LLC	69367-411	69367-0411-02
Calcium Acetate	Calcium acetate 667 mg/1	CapsuleOral	Proficient Rx LP	82804-968	82804-0968-0082804-0968-2082804-0968-30+6 more
calcium acetate	Calcium acetate 667 mg/1	CapsuleOral	AvKARE	73190-031	73190-0031-20
calcium acetate	Calcium acetate 667 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4299	70518-4299-00
Calcium Acetate	Calcium acetate 667 mg/1	CapsuleOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8632	00615-8632-39
Calcium Acetate	Calcium acetate 667 mg/1	CapsuleOral	PD-Rx Pharmaceuticals, Inc.	72789-422	72789-0422-97
Calcium Acetate	Calcium acetate 667 mg/1	CapsuleOral	Nivagen Pharmaceuticals, Inc.	75834-323	75834-0323-02
Calcium Acetate	Calcium acetate 667 mg/1	CapsuleOral	SQUARE PHARMACEUTICALS LIMITED	76483-086	76483-0086-00

All 22 Calcium Acetate NDCs

Other NDCs under ANDA 203135

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

FDA NDC Directory listings under ANDA 203135
Product	Strength	Form · route	Labeler	Product NDC
Calcium Acetate	Calcium acetate 667 mg/1	CapsuleOral	American Health Packaging	60687-589
Calcium Acetate	Calcium acetate 667 mg/1	CapsuleOral	EXELAN PHARMACEUTICALS, INC.	76282-377