Prescription drug · NDA
Sensipar (cinacalcet hydrochloride) NDC 55513-074
Cinacalcet hydrochloride 60 mg/1 · Tablet, Coated · Oral · Amgen Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55513-074-30 | 55513007430 | 30 TABLET, COATED in 1 BOTTLE, PLASTIC (55513-074-30)Marketed from Apr 4, 2004 |
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)
- Sensipar
- Generic name (nonproprietary)
- cinacalcet hydrochloride
- Active ingredients
- Cinacalcet hydrochloride — 60 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Amgen Inc
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021688
- Marketing start
- Marketing end
- Other FDA classes
- Increased Calcium-sensing Receptor Sensitivity (Mechanism)
- Identifiers
- Product ID 55513-074_42c2c9c2-6929-4952-b559-a57a1d75424eSPL ID 42c2c9c2-6929-4952-b559-a57a1d75424eSPL set ID 45028573-13c4-4c8b-ae62-6c75bba97c81RxCUI 432400, 432401, 432402, 656137, 706958, 706960UNII 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
N455513007430followed by a unit qualifier and the quantityPackage 55513-0074-30. 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)
Sensipar 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: Sensipar is 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 Sensipar is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidne…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021688
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.