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NDC 42543-0962-04 Cinacalcet 60 mg/1 Details
Cinacalcet 60 mg/1
Cinacalcet is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Strides Pharma Inc.. The primary component is CINACALCET HYDROCHLORIDE.
MedlinePlus Drug Summary
Cinacalcet is used alone or with other medications to treat secondary hyperparathyroidism (a condition in which the body produces too much parathyroid hormone [a natural substance needed to control the amount of calcium in the blood] which can cause serious problems with the bones, heart, blood vessels, and lungs) in patients with chronic kidney disease (condition in which the kidneys stop working slowly and gradually) who are being treated with dialysis (medical treatment to clean the blood when the kidneys are not working properly). Cinacalcet is also used to treat high levels of calcium in the blood of patients who have parathyroid cancer (cancer of the glands in the neck that make parathyroid hormone). Cinacalcet is in a class of medications called calcimimetics. It works by signaling the body to produce less parathyroid hormone in order to decrease the amount of calcium in the blood.
Related Packages: 42543-0962-04Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Cinacalcet
Product Information
| NDC | 42543-0962 |
|---|---|
| Product ID | 42543-962_41b403d3-1dbf-4860-a652-bbf57fcad25d |
| Associated GPIs | 30905225100330 |
| GCN Sequence Number | 053763 |
| GCN Sequence Number Description | cinacalcet HCl TABLET 60 MG ORAL |
| HIC3 | P4M |
| HIC3 Description | CALCIMIMETIC,PARATHYROID CALCIUM ENHANCER |
| GCN | 21498 |
| HICL Sequence Number | 025998 |
| HICL Sequence Number Description | CINACALCET HCL |
| Brand/Generic | Generic |
| Proprietary Name | Cinacalcet |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Cinacalcet |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 60 |
| Active Ingredient Units | mg/1 |
| Substance Name | CINACALCET HYDROCHLORIDE |
| Labeler Name | Strides Pharma Inc. |
| Pharmaceutical Class | Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA209226 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 42543-0962-04 (42543096204)
| NDC Package Code | 42543-962-04 |
|---|---|
| Billing NDC | 42543096204 |
| Package | 30 TABLET, FILM COATED in 1 BOTTLE (42543-962-04) |
| Marketing Start Date | 2020-06-01 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.63073 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | CINACALCET HCL 60 MG TABLET |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |