Prescription drug · ANDA
Cinacalcet NDC 64380-884
Cinacalcet hydrochloride 60 mg/1 · Tablet, Film coated · Oral · Strides Pharma Science Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64380-884-04 | 64380088404 | 30 TABLET, FILM COATED in 1 BOTTLE (64380-884-04)Marketed from Aug 22, 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209226
- Marketing start
- Listing expires
- Other FDA classes
- Increased Calcium-sensing Receptor Sensitivity (Mechanism)
- Identifiers
- Product ID 64380-884_40332509-df24-41a0-a75c-86d556cf0c50SPL ID 40332509-df24-41a0-a75c-86d556cf0c50SPL set ID 0ba47b6a-ba49-4d7a-82e1-1c6e49bfa5d7RxCUI 432400, 432401, 432402UNII 1K860WSG25UPC 0364380885047, 0364380883043, 0364380884040
- 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
N464380088404followed by a unit qualifier and the quantityPackage 64380-0884-04. 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 parathyroidectomy. (1.3) 1.1 Secondary Hyperparathyroidism Cinacalcet tablets 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 …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209226
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 | American Health Packaging | 60687-516 |
| Cinacalcet | Cinacalcet hydrochloride 30 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7502 |
| Cinacalcet | Cinacalcet hydrochloride 30 mg/1 | Tablet, Film coatedOral | Strides Pharma Science Limited | 64380-883 |
| Cinacalcet | Cinacalcet hydrochloride 90 mg/1 | Tablet, Film coatedOral | Strides Pharma Science Limited | 64380-885 |
| Cinacalcet | Cinacalcet hydrochloride 30 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4615 |
| Cinacalcet | Cinacalcet hydrochloride 30 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-188 |