Cinacalcet NDC 43598-368

NDC codes

FDA NDC Directory

Product NDC (as listed)43598-368Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43598-0368Add 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
43598-368-05	43598036805	500 TABLET in 1 BOTTLE (43598-368-05)Marketed from Sep 18, 2020
43598-368-30	43598036830	30 TABLET in 1 BOTTLE (43598-368-30)Marketed from Sep 18, 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 — 60 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Dr. Reddys Laboratories Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208368
Marketing start: Sep 18, 2020
Marketing end: Nov 30, 2026
Other FDA classes: Increased Calcium-sensing Receptor Sensitivity (Mechanism)
Identifiers: Product ID 43598-368_b6dbd55a-a71d-0cf8-2c73-7ebbfc032906SPL ID b6dbd55a-a71d-0cf8-2c73-7ebbfc032906SPL set ID 0837aabc-e796-0e07-8958-71f1ff6e89bfRxCUI 432400, 432401, 432402UNII 1K860WSG25UPC 0343598369303
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

N443598036805 followed by a unit qualifier and the quantity

Package 43598-0368-05. 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 5, 2024.

Indications (excerpt from the label)

Cinacalcet tablet is a positive modulator of the calcium sensing receptor indicated for: • Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. ( 1.1 ) Limitations of Use : Cinacalcet 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 ) • Hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy. ( 1.3 ) 1.1 Secondary Hyperparathyroidism Cinacalcet tablets are indicated for the treatment of secondary hyperparathyroidism (HPT…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 208368

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

FDA NDC Directory listings under ANDA 208368
Product	Strength	Form · route	Labeler	Product NDC
Cinacalcet	Cinacalcet hydrochloride 30 mg/1	TabletOral	Dr. Reddys Laboratories Inc	43598-367