What is NDC 76282-676?

76282-676 is the product NDC for Cinacalcet, Cinacalcet hydrochloride 90 mg/1 tablet, listed with the FDA by EXELAN PHARMACEUTICALS INC.. It has 1 package NDC, shown above in 10- and 11-digit form.

EXELAN PHARMACEUTICALS INC., NDC labeler code 76282. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Cinacalcet?

44 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Cinacalcet NDC 76282-676 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)76282-676Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76282-0676Add 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
76282-676-30	7628206763076282067630	30 TABLET in 1 BOTTLE (76282-676-30)Marketed from Apr 14, 2020

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): Cinacalcet
Generic name (nonproprietary): cinacalcet
Active ingredients: Cinacalcet hydrochloride — 90 mg/1
Dosage form: Tablet
Route: Oral
Labeler: EXELAN PHARMACEUTICALS INC.NDC labeler code 76282
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208915
Marketing start: Apr 14, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Increased Calcium-sensing Receptor Sensitivity (Mechanism)
Identifiers: Product ID 76282-676_d4eda09a-6371-49ea-bc20-054b55e432e4SPL ID d4eda09a-6371-49ea-bc20-054b55e432e4SPL set ID 04a978cb-d57b-4f1e-ba14-316b6f9abe33RxCUI 432400, 432401, 432402UNII 1K860WSG25UPC 0376282674308, 0376282675305, 0376282676302
Pharmacologic class: Calcium-sensing Receptor Agonist

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

N476282067630 followed by a unit qualifier and the quantity

Package 76282-0676-30. 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 Apr 14, 2020.

Indications (excerpt from the label)

Cinacalcet hydrochloride is a calcium-sensing receptor agonist indicated for: Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. ( 1.1 ) Limitations of Use: Cinacalcet hydrochloride tablets are not indicated for use in patients with CKD who are not on dialysis. Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). ( 1.2 ) Severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy. ( 1.3 ) 1.1 Secondary Hyperparathyroidism Cinacalcet hydrochloride tablets are indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis [see…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76282-676

What is NDC 76282-676?: 76282-676 is the product NDC for Cinacalcet, Cinacalcet hydrochloride 90 mg/1 tablet, listed with the FDA by EXELAN PHARMACEUTICALS INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Cinacalcet.
What is the active ingredient?: Cinacalcet hydrochloride.
Who is the labeler?: EXELAN PHARMACEUTICALS INC., NDC labeler code 76282. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cinacalcet?: 44 other product NDCs are listed under this name. See all Cinacalcet 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 Cinacalcet NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Cinacalcet	Cinacalcet hydrochloride 30 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4615	70518-4615-00
Cinacalcet	Cinacalcet hydrochloride 30 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	84386-111	84386-0111-0184386-0111-0584386-0111-30+1 more
Cinacalcet	Cinacalcet hydrochloride 60 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	84386-112	84386-0112-0184386-0112-0584386-0112-30+1 more
Cinacalcet	Cinacalcet hydrochloride 90 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	84386-113	84386-0113-0184386-0113-0584386-0113-30+1 more
Cinacalcet	Cinacalcet hydrochloride 30 mg/1	Tablet, Film coatedOral	AvPAK	50268-188	50268-0188-12
Cinacalcet	Cinacalcet hydrochloride 30 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-516	60687-0516-21
Cinacalcet	Cinacalcet hydrochloride 30 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-7502	00904-7502-04
Cinacalcet	Cinacalcet hydrochloride 30 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc.	72865-150	72865-0150-3072865-0150-31
Cinacalcet	Cinacalcet hydrochloride 60 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc.	72865-151	72865-0151-3072865-0151-31
Cinacalcet	Cinacalcet hydrochloride 90 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc.	72865-152	72865-0152-3072865-0152-31

All 45 Cinacalcet NDCs

Other NDCs under ANDA 208915

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

FDA NDC Directory listings under ANDA 208915
Product	Strength	Form · route	Labeler	Product NDC
Cinacalcet	Cinacalcet hydrochloride 30 mg/1	TabletOral	Cipla USA Inc.	69097-410
Cinacalcet	Cinacalcet hydrochloride 60 mg/1	TabletOral	Cipla USA Inc.	69097-411
Cinacalcet	Cinacalcet hydrochloride 90 mg/1	TabletOral	Cipla USA Inc.	69097-412
Cinacalcet	Cinacalcet hydrochloride 30 mg/1	TabletOral	Bryant Ranch Prepack	71335-2761
Cinacalcet	Cinacalcet hydrochloride 60 mg/1	TabletOral	Bryant Ranch Prepack	71335-2762
Cinacalcet	Cinacalcet hydrochloride 90 mg/1	TabletOral	Bryant Ranch Prepack	71335-2763
Cinacalcet	Cinacalcet hydrochloride 90 mg/1	TabletOral	Bryant Ranch Prepack	72162-2527
Cinacalcet	Cinacalcet hydrochloride 30 mg/1	TabletOral	EXELAN PHARMACEUTICALS INC.	76282-674
Cinacalcet	Cinacalcet hydrochloride 60 mg/1	TabletOral	EXELAN PHARMACEUTICALS INC.	76282-675