DrugDashboards

Cinacalcet

Cinacalcet · CINACALCET HYDROCHLORIDE 60 mg/1 · Tablet · Oral · Dr. Reddys Laboratories Inc

NDC 43598-0368-05 · 500 TABLET in 1 BOTTLE · ANDA · View full market →

The short version

5 companies supply this market — a reasonable cushion if one runs into trouble. Historically, drugs in this position went on to a new shortage within 90 days about 0.3% of the time — roughly 2× the typical drug (0.1%).

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Medicare Part D

No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.

How Part D pricing works →

NADAC price per unit

No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

90-day shortage risk (model v2)

0.3%chance of a new FDA shortage posting for cinacalcet (oral solid) in the next 90 days

9 Class I/II recall(s) in 12 months · price up 26% YoY · sole-source market

For scale: the typical drug’s chance is about 0.1% — this one is 2× that.

Backtested statistical model over the whole market, not this package alone. Model details →

Where it's made

Establishments this product's FDA label declares, located via FDA registration data. How we built this →

Regulatory

Application
ANDA208368
TE code
AB
Approval date
Sep 18, 2020
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · OngoingOct 9, 2024
    Dr. Reddy's Laboratories, Inc. — CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
  • Class II · OngoingOct 9, 2024
    Dr. Reddy's Laboratories, Inc. — CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
  • Class II · OngoingOct 9, 2024
    Dr. Reddy's Laboratories, Inc. — CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

Manufacturers of Cinacalcet (Tablet)

LabelerStrengthFirst seenLast seen
Bryant Ranch PrepackCINACALCET HYDROCHLORIDE 90 mg/1Jul 15, 2026Sep 3, 2026
Amneal Pharmaceuticals LLCCINACALCET HYDROCHLORIDE 30 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCCINACALCET HYDROCHLORIDE 90 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCCINACALCET HYDROCHLORIDE 60 mg/1Jul 15, 2026Sep 2, 2026
Bryant Ranch PrepackCINACALCET HYDROCHLORIDE 60 mg/1Jul 15, 2026Sep 2, 2026
Bryant Ranch PrepackCINACALCET HYDROCHLORIDE 30 mg/1Jul 15, 2026Sep 2, 2026
Cipla USA Inc.CINACALCET HYDROCHLORIDE 60 mg/1Jul 15, 2026Sep 2, 2026
Cipla USA Inc.CINACALCET HYDROCHLORIDE 30 mg/1Jul 15, 2026Sep 2, 2026
Cipla USA Inc.CINACALCET HYDROCHLORIDE 90 mg/1Jul 15, 2026Sep 2, 2026
Dr. Reddys Laboratories IncCINACALCET HYDROCHLORIDE 30 mg/1Jul 15, 2026Sep 2, 2026
Dr. Reddys Laboratories IncCINACALCET HYDROCHLORIDE 60 mg/1Jul 15, 2026Sep 2, 2026
Exelan Pharmaceuticals Inc.CINACALCET HYDROCHLORIDE 60 mg/1Jul 15, 2026Sep 2, 2026
Exelan Pharmaceuticals Inc.CINACALCET HYDROCHLORIDE 30 mg/1Jul 15, 2026Sep 2, 2026
Exelan Pharmaceuticals Inc.CINACALCET HYDROCHLORIDE 90 mg/1Jul 15, 2026Sep 2, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Cinacalcet — NDC 43598-0368-05," retrieved September 3, 2026, https://drugdashboards.com/drug/43598036805.

Free to cite with attribution — see how the data is put together.