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Active ingredient

Cinacalcet

51 finished FDA listings contain Cinacalcet as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
CINACALCET HYDROCHLORIDE
Dosage forms
Tablet, Tablet, Coated, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
17
Strengths listed
30 mg/1 · 60 mg/1 · 90 mg/1
Brand names in FDA listings
Cinacalcet Hydrochloride, Sensipar

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 407990

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 021688AMGEN2004-03-083
ANDA 208915CIPLA2018-03-0810
ANDA 206125AUROBINDO PHARMA LTD2018-03-083
ANDA 209226STRIDES PHARMA2018-04-307
ANDA 207008SUN PHARM2018-10-113
ANDA 210570ALKEM LABS LTD2019-05-1711
ANDA 211892ACCORD HLTHCARE2020-05-153
ANDA 208368DR REDDYS2020-09-182
ANDA 209403HETERO LABS LTD V2020-10-076
ANDA 204364STEVENS J2021-12-023

Official labeling on DailyMed

Showing the 12 most recent of 28 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.