Prescription drug · ANDA
Cinacalcet NDC 72162-1845
Cinacalcet hydrochloride 90 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-1845-3 | 72162184503 | 30 TABLET, FILM COATED in 1 BOTTLE (72162-1845-3)Marketed from Mar 8, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210570
- Marketing start
- Listing expires
- Other FDA classes
- Increased Calcium-sensing Receptor Sensitivity (Mechanism)
- Identifiers
- Product ID 72162-1845_d29bbaee-747f-438e-8d5a-5c013e47040dSPL ID d29bbaee-747f-438e-8d5a-5c013e47040dSPL set ID f1cfc943-5b70-4451-a1fc-61e45e669d84RxCUI 432400UNII 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
N472162184503followed by a unit qualifier and the quantityPackage 72162-1845-03. 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 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) Severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy. (1.3) 1.1 Secondary Hyperparathyroidism Cinacalcet are indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis [see Clinical Studies ( 14.1 )]. Limitations of Use…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210570
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 | Cinacalcet hydrochloride 30 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-1843 |
| Cinacalcet | Cinacalcet hydrochloride 60 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-1844 |
| Cinacalcet | Cinacalcet hydrochloride 30 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-503 |
| Cinacalcet | Cinacalcet hydrochloride 60 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-504 |
| Cinacalcet | Cinacalcet hydrochloride 90 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-505 |
| Cinacalcet | Cinacalcet hydrochloride 60 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-9607 |
| Cinacalcet | Cinacalcet hydrochloride 30 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-8763 |
| Cinacalcet | Cinacalcet hydrochloride 60 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-8764 |
| Cinacalcet | Cinacalcet hydrochloride 90 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-9606 |
| Cinacalcet | Cinacalcet hydrochloride 30 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-9608 |