Cinacalcet NDC 47335-380

NDC codes

FDA NDC Directory

Product NDC (as listed)47335-380Labeler and product segments. Claims need a package NDC.

Product NDC at billing width47335-0380Add 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
47335-380-83	47335038083	30 TABLET, FILM COATED in 1 BOTTLE (47335-380-83)Marketed from May 15, 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): Cinacalcet
Generic name (nonproprietary): cinacalcet
Active ingredients: Cinacalcet hydrochloride — 60 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Sun Pharmaceutical Industries, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207008
Marketing start: May 15, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Increased Calcium-sensing Receptor Sensitivity (Mechanism)
Identifiers: Product ID 47335-380_fb601aec-aba6-4bec-a98d-51e556fef95cSPL ID fb601aec-aba6-4bec-a98d-51e556fef95cSPL set ID 092553cf-1bcd-4c19-9adf-b46f2bda5c9eRxCUI 432400, 432401, 432402UNII 1K860WSG25UPC 0347335600834
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

N447335038083 followed by a unit qualifier and the quantity

Package 47335-0380-83. 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 Dec 17, 2021.

Indications (excerpt from the label)

Cinacalcet 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 is 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) in adult patients with chro…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 207008

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

FDA NDC Directory listings under ANDA 207008
Product	Strength	Form · route	Labeler	Product NDC
Cinacalcet	Cinacalcet hydrochloride 30 mg/1	Tablet, Film coatedOral	Sun Pharmaceutical Industries, Inc.	47335-379
Cinacalcet	Cinacalcet hydrochloride 90 mg/1	Tablet, Film coatedOral	Sun Pharmaceutical Industries, Inc.	47335-600