Prescription drug · ANDA
Cinacalcet Hydrochloride (cinacalcet) NDC 65162-213
Cinacalcet hydrochloride 90 mg/1 · Tablet · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-213-03 | 65162021303 | 30 TABLET in 1 BOTTLE (65162-213-03)Marketed from Dec 6, 2021 | |
| 65162-213-10 | 65162021310 | 100 TABLET in 1 BOTTLE (65162-213-10)Marketed from Dec 6, 2021 | |
| 65162-213-25 | 65162021325 | 250 TABLET in 1 BOTTLE (65162-213-25)Marketed from Dec 6, 2021 |
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 Hydrochloride
- Generic name (nonproprietary)
- cinacalcet
- Active ingredients
- Cinacalcet hydrochloride — 90 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204364
- Marketing start
- Listing expires
- Other FDA classes
- Increased Calcium-sensing Receptor Sensitivity (Mechanism)
- Identifiers
- Product ID 65162-213_4d63252a-b953-4066-b38c-a468580dc407SPL ID 4d63252a-b953-4066-b38c-a468580dc407SPL set ID 28262843-b0a8-4ca7-8b92-41b7f0e896b4RxCUI 432400, 432401, 432402UNII 1K860WSG25UPC 0365162155105, 0365162157109, 0365162213102
- 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
N465162021303followed by a unit qualifier and the quantityPackage 65162-0213-03. 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 .
Indications (excerpt from the label)
Cinacalcet tablets are 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…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204364
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Cinacalcet Hydrochloridecinacalcet | Cinacalcet hydrochloride 30 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-155 |
| Cinacalcet Hydrochloridecinacalcet | Cinacalcet hydrochloride 60 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-157 |