Cinacalcet NDC 16729-442

NDC codes

FDA NDC Directory

Product NDC (as listed)16729-442Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16729-0442Add 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
16729-442-10	16729044210	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-442-10)Marketed from Jun 16, 2020
16729-442-15	16729044215	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-442-15)Marketed from Jun 25, 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, Film coated
Route: Oral
Labeler: Accord Healthcare, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211892
Marketing start: Jun 16, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Increased Calcium-sensing Receptor Sensitivity (Mechanism)
Identifiers: Product ID 16729-442_40aa0834-3fd8-c230-e063-6294a90a800dSPL ID 40aa0834-3fd8-c230-e063-6294a90a800dSPL set ID 6bad4e06-c0a1-4123-83c2-67d3b081e8a9RxCUI 432400, 432401, 432402UNII 1K860WSG25
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

N416729044210 followed by a unit qualifier and the quantity

Package 16729-0442-10. 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 Oct 8, 2025.

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 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) in adult pat…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 211892

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

FDA NDC Directory listings under ANDA 211892
Product	Strength	Form · route	Labeler	Product NDC
Cinacalcet	Cinacalcet hydrochloride 30 mg/1	Tablet, Film coatedOral	Accord Healthcare, Inc.	16729-440
Cinacalcet	Cinacalcet hydrochloride 60 mg/1	Tablet, Film coatedOral	Accord Healthcare, Inc.	16729-441