Prescription drug · ANDA
Cinacalcet NDC 69097-411
Cinacalcet hydrochloride 60 mg/1 · Tablet · Oral · Cipla USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-411-02 | 69097041102 | 30 TABLET in 1 BOTTLE (69097-411-02)Marketed from Mar 8, 2018 |
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
- Route
- Oral
- Labeler
- Cipla USA Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208915
- Marketing start
- Listing expires
- Other FDA classes
- Increased Calcium-sensing Receptor Sensitivity (Mechanism)
- Identifiers
- Product ID 69097-411_383a7dc8-b195-4868-8774-f16a5558771eSPL ID 383a7dc8-b195-4868-8774-f16a5558771eSPL set ID 02b8c11b-99e8-4039-b6fa-a9c38d2f48faRxCUI 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
N469097041102followed by a unit qualifier and the quantityPackage 69097-0411-02. 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 ) 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 Cinacalcet tablets are indicated for the treatment of secondary hyperparathyroidism (HPT) in adult pa…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208915
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 | TabletOral | Cipla USA Inc. | 69097-410 |
| Cinacalcet | Cinacalcet hydrochloride 90 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2527 |
| Cinacalcet | Cinacalcet hydrochloride 90 mg/1 | TabletOral | Cipla USA Inc. | 69097-412 |
| Cinacalcet | Cinacalcet hydrochloride 30 mg/1 | TabletOral | EXELAN PHARMACEUTICALS INC. | 76282-674 |
| Cinacalcet | Cinacalcet hydrochloride 60 mg/1 | TabletOral | EXELAN PHARMACEUTICALS INC. | 76282-675 |
| Cinacalcet | Cinacalcet hydrochloride 90 mg/1 | TabletOral | EXELAN PHARMACEUTICALS INC. | 76282-676 |
| Cinacalcet | Cinacalcet hydrochloride 30 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2761 |
| Cinacalcet | Cinacalcet hydrochloride 60 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2762 |
| Cinacalcet | Cinacalcet hydrochloride 90 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2763 |