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Active ingredient

Everolimus

88 finished FDA listings contain Everolimus as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
EVEROLIMUS
Dosage forms
Tablet, Tablet, For Suspension
Routes
Oral
Manufacturers / labelers
15
Strengths listed
.25 mg/1 · .5 mg/1 · .75 mg/1 · 1 mg/1 · 10 mg/1 · 2 mg/1 · 2.5 mg/1 · 3 mg/1 · 5 mg/1 · 7.5 mg/1
Brand names in FDA listings
Afinitor, Afinitor Disperz, Everolimus, Torpenz, Yulithira, Zortress

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 141704

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 022334NOVARTIS2009-03-304
NDA 021560NOVARTIS2010-04-204
NDA 203985NOVARTIS PHARM2012-08-293
ANDA 206133HIKMA2018-04-124
ANDA 210050TEVA PHARMS USA2019-12-094
ANDA 207486HIKMA2020-06-084
ANDA 214182BIOCON PHARMA2021-02-1112
ANDA 205426BRECKENRIDGE2021-03-0512
ANDA 205432BRECKENRIDGE2021-05-208
ANDA 205775PH HEALTH2021-10-184
ANDA 214138ALKEM LABS LTD2021-11-264
ANDA 218863AMNEAL2025-01-103
ANDA 217640NATCO2025-01-283
ANDA 216140BIOCON PHARMA2025-04-094
ANDA 219955NEOCUBES PHARMA2025-10-304
ANDA 217216BIOCON PHARMA2026-01-093
ANDA 219533EUGIA PHARMA2026-02-254
ANDA 219464PHARMAZONE2026-06-304

Official labeling on DailyMed

Showing the 12 most recent of 20 labels.

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