Prescription drug · ANDA
Cinacalcet NDC 67877-504
Cinacalcet hydrochloride 60 mg/1 · Tablet, Film coated · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-504-01 | 67877050401 | 100 TABLET, FILM COATED in 1 BOTTLE (67877-504-01)Marketed from May 18, 2019 | |
| 67877-504-30 | 67877050430 | 30 TABLET, FILM COATED in 1 BOTTLE (67877-504-30)Marketed from May 18, 2019 | |
| 67877-504-33 | 67877050433 | 10 BLISTER PACK in 1 CARTON (67877-504-33) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from May 18, 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
- Ascend Laboratories, LLC
- 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 67877-504_7dc83b54-a624-48db-ad2d-ee000a6d9c47SPL ID 7dc83b54-a624-48db-ad2d-ee000a6d9c47SPL set ID 55f95ae0-84ac-4ae4-b7a0-7590ab919ae1RxCUI 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
N467877050401followed by a unit qualifier and the quantityPackage 67877-0504-01. 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 90 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-1845 |
| Cinacalcet | Cinacalcet hydrochloride 30 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-503 |
| 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 |