Prescription drug · ANDA
Cinacalcet NDC 43598-367
Cinacalcet hydrochloride 30 mg/1 · Tablet · Oral · Dr. Reddys Laboratories Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-367-05 | 4359803670543598036705 | 500 TABLET in 1 BOTTLE (43598-367-05)Marketed from Sep 18, 2020 | |
| 43598-367-30 | 4359803673043598036730 | 30 TABLET in 1 BOTTLE (43598-367-30)Marketed from Sep 18, 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 — 30 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Dr. Reddys Laboratories IncNDC labeler code 43598
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208368
- Marketing start
- Marketing end
- Other FDA classes
- Increased Calcium-sensing Receptor Sensitivity (Mechanism)
- Identifiers
- Product ID 43598-367_b6dbd55a-a71d-0cf8-2c73-7ebbfc032906SPL ID b6dbd55a-a71d-0cf8-2c73-7ebbfc032906SPL set ID 0837aabc-e796-0e07-8958-71f1ff6e89bfRxCUI 432400, 432401, 432402UNII 1K860WSG25UPC 0343598369303
- 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
N443598036705followed by a unit qualifier and the quantityPackage 43598-0367-05. 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 tablet 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…
Excerpt only. Read the full label for complete information.
About NDC 43598-367
- What is NDC 43598-367?
- 43598-367 is the product NDC for Cinacalcet, Cinacalcet hydrochloride 30 mg/1 tablet, listed with the FDA by Dr. Reddys Laboratories Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cinacalcet.
- What is the active ingredient?
- Cinacalcet hydrochloride.
- Who is the labeler?
- Dr. Reddys Laboratories Inc, NDC labeler code 43598. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cinacalcet?
- 44 other product NDCs are listed under this name. See all Cinacalcet NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cinacalcet products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cinacalcet | Cinacalcet hydrochloride 30 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4615 | 70518-4615-00 |
| Cinacalcet | Cinacalcet hydrochloride 30 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 84386-111 | 84386-0111-0184386-0111-0584386-0111-30+1 more |
| Cinacalcet | Cinacalcet hydrochloride 60 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 84386-112 | 84386-0112-0184386-0112-0584386-0112-30+1 more |
| Cinacalcet | Cinacalcet hydrochloride 90 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 84386-113 | 84386-0113-0184386-0113-0584386-0113-30+1 more |
| Cinacalcet | Cinacalcet hydrochloride 30 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-188 | 50268-0188-12 |
| Cinacalcet | Cinacalcet hydrochloride 30 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-516 | 60687-0516-21 |
| Cinacalcet | Cinacalcet hydrochloride 30 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7502 | 00904-7502-04 |
| Cinacalcet | Cinacalcet hydrochloride 30 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-150 | 72865-0150-3072865-0150-31 |
| Cinacalcet | Cinacalcet hydrochloride 60 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-151 | 72865-0151-3072865-0151-31 |
| Cinacalcet | Cinacalcet hydrochloride 90 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-152 | 72865-0152-3072865-0152-31 |
Other NDCs under ANDA 208368
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 60 mg/1 | TabletOral | Dr. Reddys Laboratories Inc | 43598-368 |