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Prescription medicine · generic available

Cinacalcet

Brand names: Sensipar

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

NoBoxed warning
None listedFDA shortage list
20Recalls (FDA reports)
17Companies
2004First FDA approval on file

Quick answers

What is Cinacalcet used for?
The FDA-approved label (Sensipar, Amgen Inc, December 7, 2025) says: “Sensipar is a positive modulator of the calcium sensing receptor indicated for: Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. Limitations of Use: Sensipar is not indicated for use in patients with CKD who are not on dialysis Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Cinacalcet have a boxed warning?
No. None of the 28 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Cinacalcet?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Cinacalcet been recalled?
FDA enforcement reports list 20 recalls of products of this medicine; the newest started June 29, 2026 (Class II). A recall usually concerns specific lots, not every product.
Who makes Cinacalcet?
17 companies list prescription products of Cinacalcet in the FDA NDC Directory, including Bryant Ranch Prepack, XLCare Pharmaceuticals, Inc. and Exelan Pharmaceuticals Inc..

What Cinacalcet is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Sensipar is a positive modulator of the calcium sensing receptor indicated for: Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. Limitations of Use: Sensipar is not indicated for use in patients with CKD who are not on dialysis Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). …

— FDA label: Sensipar, Amgen Inc, effective December 7, 2025. Read the full label on DailyMed →

The FDA has 28 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Chronic kidney disease

Related medical specialties

Nephrology

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 28 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsTablet, film coated · Tablet · Tablet, coated
RouteOral
Prescription products51 in the FDA NDC Directory
Brand namesSensipar

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Cinacalcet, by strength and form
Strength and formGeneric or brandPharmacies pay
cinacalcet hydrochloride 30 mg
tablet		 Generic $0.4190 per tablet
cinacalcet hydrochloride 30 mg
tablet, film coated		 Generic $0.4190 per tablet
cinacalcet hydrochloride 60 mg
tablet		 Generic $0.7720 per tablet
cinacalcet hydrochloride 60 mg
tablet, film coated		 Generic $0.7720 per tablet
cinacalcet hydrochloride 90 mg
tablet		 Generic $1.06 per tablet
cinacalcet hydrochloride 90 mg
tablet, film coated		 Generic $1.06 per tablet

NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA021688
SENSIPAR		 AmgenMarch 8, 2004 15, latest December 5, 2019
2019: Labeling · 2019: Labeling · 2019: Labeling

Generic approvals (9)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. June 29, 2026 · Class II · Ongoing · D-0676-2026

    cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

    Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 6909 — Cipla USA, Inc.

  2. June 29, 2026 · Class II · Ongoing · D-0675-2026

    cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

    Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 6909 — Cipla USA, Inc.

  3. June 29, 2026 · Class II · Ongoing · D-0661-2026

    cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

    Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 6909 — Cipla USA, Inc.

  4. June 4, 2026 · Class II · Ongoing · D-0616-2026

    CGMP Deviations

    Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks, CA 91320-1799, Made in Japan. NDC 55513-075-30 — Amgen, Inc.

  5. June 4, 2026 · Class II · Ongoing · D-0614-2026

    CGMP Deviations

    Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-074-30 — Amgen, Inc.

  6. June 4, 2026 · Class II · Ongoing · D-0613-2026

    CGMP Deviations

    Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-073-30 — Amgen, Inc.

  7. March 16, 2026 · Class II · Ongoing · D-0451-2026

    CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit

    Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. ND — Cipla USA, Inc.

  8. March 16, 2026 · Class II · Ongoing · D-0449-2026

    CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit

    Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. ND — Cipla USA, Inc.

  9. March 16, 2026 · Class II · Ongoing · D-0450-2026

    CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit

    Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. ND — Cipla USA, Inc.

  10. November 14, 2025 · Class II · Ongoing · D-0226-2026

    CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

    Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-412-02 — Cipla USA, Inc.

  11. November 14, 2025 · Class II · Ongoing · D-0225-2026

    CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

    Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02 — Cipla USA, Inc.

  12. November 14, 2025 · Class II · Ongoing · D-0224-2026

    CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

    Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02 — Cipla USA, Inc.

  13. July 9, 2025 · Class II · Ongoing · D-0546-2025

    Failed Dissolution Specifications.

    Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, India; Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380-885-04 — Strides Pharma, Inc.

  14. October 10, 2024 · Class II · Terminated · D-0032-2025

    CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

    Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-10, b) 90 Tablets per bottle, NDC: 16729-442-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceut — ACCORD HEALTHCARE, INC.

  15. October 10, 2024 · Class II · Terminated · D-0030-2025

    CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

    Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC: 16729-440-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuti — ACCORD HEALTHCARE, INC.

  16. October 10, 2024 · Class II · Terminated · D-0031-2025

    CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

    Cinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-10, b) 90 Tablets per bottle, NDC: 16729-441-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceut — ACCORD HEALTHCARE, INC.

  17. October 9, 2024 · Class II · Ongoing · D-0028-2025

    CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

    Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30. — Dr. Reddy's Laboratories, Inc.

  18. October 9, 2024 · Class II · Ongoing · D-0027-2025

    CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

    Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30. — Dr. Reddy's Laboratories, Inc.

  19. October 9, 2024 · Class II · Ongoing · D-0026-2025

    CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

    Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-367-30. — Dr. Reddy's Laboratories, Inc.

  20. January 18, 2024 · Class II · Completed · D-0263-2024

    CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

    Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191 (U — SUN PHARMACEUTICAL INDUSTRIES INC

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Official identifiers

RxCUI (RxNorm)432400, 432401, 432402, 656137, 706958, 706960
SPL set ID of the quoted label45028573-13c4-4c8b-ae62-6c75bba97c81
FDA labels (SPL)28
FDA applicationsNDA021688, 9 ANDA
Active ingredients (FDA)CINACALCET

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Sensipar, Amgen Inc, effective December 7, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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