Drugplain

Cinacalcet Hydrochloride 30 mg/1

Cinacalcet · TABLET · Amneal Pharmaceuticals LLC

8 Recalls on Record
Plain English

Cinacalcet Hydrochloride is a tablet containing cinacalcet at 30 mg/1, taken oral. Manufactured by Amneal Pharmaceuticals LLC.

Key Facts

Brand Name
Cinacalcet Hydrochloride
Generic Name
Cinacalcet
NDC Code (Product)
65162-155
Manufacturer
Amneal Pharmaceuticals LLC
Strength
30 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA204364
Marketing Start
12/06/2021

Recall History

8 Recalls on Record
Class II03/16/2026

Cipla USA, Inc.

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

OngoingVoluntary: Firm initiated
Class II03/16/2026

Cipla USA, Inc.

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

OngoingVoluntary: Firm initiated
Class II03/07/2025

Slate Run Pharmaceuticals

CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.

CompletedVoluntary: Firm initiated
Class II11/14/2025

Cipla USA, Inc.

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

OngoingVoluntary: Firm initiated
Class II11/14/2025

Cipla USA, Inc.

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

OngoingVoluntary: Firm initiated
Class II11/14/2025

Cipla USA, Inc.

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

OngoingVoluntary: Firm initiated
Class II03/16/2026

Cipla USA, Inc.

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

OngoingVoluntary: Firm initiated
Class II03/07/2025

Slate Run Pharmaceuticals

CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.

CompletedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

death434 reports
off label use385 reports
drug ineffective354 reports
hypocalcaemia267 reports
nausea221 reports
vomiting191 reports
hypercalcaemia182 reports
diarrhoea168 reports
acute kidney injury140 reports
calciphylaxis139 reports

Frequently Asked Questions

What is Cinacalcet Hydrochloride used for?

Cinacalcet Hydrochloride contains Cinacalcet. It is a tablet taken oral. Consult your doctor for specific uses.

Is Cinacalcet Hydrochloride a controlled substance?

Cinacalcet Hydrochloride is not classified as a controlled substance by the DEA.

What is the generic name for Cinacalcet Hydrochloride?

The generic name for Cinacalcet Hydrochloride is Cinacalcet. There are 12 other brand versions of Cinacalcet.

What is the NDC code for Cinacalcet Hydrochloride 30 mg/1?

The NDC (National Drug Code) for Cinacalcet Hydrochloride 30 mg/1 is 65162-155, listed by Amneal Pharmaceuticals LLC.