Prescription drug · ANDA
Cinacalcet NDC 31722-104
Cinacalcet hydrochloride 60 mg/1 · Tablet, Film coated · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-104-30 | 31722010430 | 30 TABLET, FILM COATED in 1 BOTTLE (31722-104-30)Marketed from Oct 7, 2020 | |
| 31722-104-31 | 31722010431 | 3 BLISTER PACK in 1 CARTON (31722-104-31) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Oct 7, 2020 |
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
- Camber Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209403
- Marketing start
- Listing expires
- Other FDA classes
- Increased Calcium-sensing Receptor Sensitivity (Mechanism)
- Identifiers
- Product ID 31722-104_5480ebd3-5b39-4f8b-bb03-05617f6f519fSPL ID 5480ebd3-5b39-4f8b-bb03-05617f6f519fSPL set ID 5480ebd3-5b39-4f8b-bb03-05617f6f519fRxCUI 432400, 432401, 432402UNII 1K860WSG25UPC 0331722103305, 0331722104302, 0331722105309
- 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
N431722010430followed by a unit qualifier and the quantityPackage 31722-0104-30. 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)
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 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 ) • Severe hypercalcemia in adult patients with primary HPT 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 patients with chronic kidney disease (CKD) on dialysis [see Clinical Studies (…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209403
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 | Camber Pharmaceuticals, Inc. | 31722-103 |
| Cinacalcet | Cinacalcet hydrochloride 90 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-105 |
| Cinacalcet | Cinacalcet hydrochloride 60 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-151 |
| Cinacalcet | Cinacalcet hydrochloride 30 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-150 |
| Cinacalcet | Cinacalcet hydrochloride 90 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-152 |