Prescription drug · ANDA
Cinacalcet NDC 63629-9608
Cinacalcet hydrochloride 30 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-9608-1 | 6362996080163629960801 | 30 TABLET, FILM COATED in 1 BOTTLE (63629-9608-1)Marketed from Dec 28, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210570
- Marketing start
- Listing expires
- Other FDA classes
- Increased Calcium-sensing Receptor Sensitivity (Mechanism)
- Identifiers
- Product ID 63629-9608_4e48a9f7-69dc-4e8c-ac47-99bf39954e4aSPL ID 4e48a9f7-69dc-4e8c-ac47-99bf39954e4aSPL set ID 60e6264c-723c-49b2-a246-827b15ff219cRxCUI 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
N463629960801followed by a unit qualifier and the quantityPackage 63629-9608-01. 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 undergo parathyroidectomy. (1.3) 1.1 Secondary Hyperparathyroidism Cinacalcet 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 Use…
Excerpt only. Read the full label for complete information.
About NDC 63629-9608
- What is NDC 63629-9608?
- 63629-9608 is the product NDC for Cinacalcet, Cinacalcet hydrochloride 30 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, 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?
- Bryant Ranch Prepack, NDC labeler code 63629. 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 210570
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 | Bryant Ranch Prepack | 63629-8763 |
| Cinacalcet | Cinacalcet hydrochloride 60 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-8764 |
| Cinacalcet | Cinacalcet hydrochloride 90 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-9606 |
| Cinacalcet | Cinacalcet hydrochloride 60 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-9607 |
| Cinacalcet | Cinacalcet hydrochloride 30 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-503 |
| Cinacalcet | Cinacalcet hydrochloride 60 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-504 |
| Cinacalcet | Cinacalcet hydrochloride 90 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-505 |
| Cinacalcet | Cinacalcet hydrochloride 30 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-1843 |
| Cinacalcet | Cinacalcet hydrochloride 60 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-1844 |
| Cinacalcet | Cinacalcet hydrochloride 90 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-1845 |