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Afinitor

everolimus · Tablet, for Suspension

Prescription NDA TE AB RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Afinitor Disperz
Generic name
everolimus
Dosage form
Tablet, for Suspension
Route
Oral
Marketing category
NDA · NDA
Labeler
Novartis Pharmaceuticals Corporation
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
3
Packages
3
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Everolimus 2 mg/1 845507 View
Everolimus 3 mg/1 845507 View
Everolimus 5 mg/1 845507 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, for Suspension
Route of administration
Oral
Presentations
6

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Cytochrome P450 2D6 Inhibitors [MoA] MoA All 72 members
Cytochrome P450 3A4 Inhibitors [MoA] MoA All 118 members
Decreased Immunologic Activity [PE] PE All 11 members
Kinase Inhibitor [EPC] EPC All 89 members
Protein Kinase Inhibitors [MoA] MoA All 41 members
mTOR Inhibitor Immunosuppressant [EPC] EPC All 11 members
mTOR Inhibitors [MoA] MoA All 11 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
203985
Application type
NDA · New Drug Application
Approval date
August 29, 2012
Sponsor
NOVARTIS PHARM
Products on application
3
Submissions recorded
18
Products approved under application 203985.
Product Trade name Form Strength Ingredient Status TE Flags
203985-001 AFINITOR DISPERZ TABLET, FOR SUSPENSION EVEROLIMUS Prescription AB RLD
203985-002 AFINITOR DISPERZ TABLET, FOR SUSPENSION EVEROLIMUS Prescription AB RLD
203985-003 AFINITOR DISPERZ TABLET, FOR SUSPENSION EVEROLIMUS Prescription AB RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
AB
Reference Listed Drug
Yes
Reference Standard
Yes

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 203985.
Type No. Action Status Date Review
Supplement 28 Labeling Approved June 1, 2026 Standard
Supplement 27 Manufacturing (CMC) Approved March 11, 2024 N/A
Supplement 23 Labeling Approved February 1, 2022 Standard
Supplement 20 Labeling Approved April 16, 2021 Standard
Supplement 16 Labeling Approved February 13, 2020 Standard
Supplement 17 Labeling Approved January 22, 2020 Standard
Supplement 13 Efficacy Approved April 10, 2018 Standard
Supplement 10 Efficacy Approved January 29, 2016 Standard
Supplement 9 Manufacturing (CMC) Approved August 24, 2015 Priority
Supplement 6 Manufacturing (CMC) Approved July 1, 2015 Priority
Supplement 8 Labeling Approved January 23, 2015 Standard
Supplement 7 Labeling Approved July 1, 2014 Standard
Supplement 5 Labeling Approved February 20, 2014 Standard
Supplement 4 Labeling Approved February 20, 2014 Standard
Supplement 2 Labeling Approved February 20, 2014 Standard
Supplement 3 Efficacy Approved November 6, 2013 Standard
Supplement 1 Manufacturing (CMC) Approved March 26, 2013 Priority
Original application 1 Type 3 - New Dosage Form Approved August 29, 2012 Priority

Review documents

  • 0 · Supplement · June 2, 2026
  • 0 · Supplement · June 2, 2026
  • 0 · Supplement · May 6, 2024
  • 0 · Supplement · May 6, 2024
  • 0 · Supplement · February 3, 2022
  • 0 · Supplement · February 2, 2022
  • 0 · Supplement · April 19, 2021
  • 0 · Supplement · April 19, 2021
  • 0 · Supplement · February 14, 2020
  • 0 · Supplement · February 14, 2020
  • 0 · Supplement · January 23, 2020
  • 0 · Supplement · January 23, 2020
  • 0 · Supplement · April 11, 2018
  • 0 · Supplement · February 2, 2016
  • 0 · Supplement · February 1, 2016
  • 0 · Supplement · January 29, 2015
  • 0 · Supplement · January 26, 2015
  • 0 · Supplement · July 3, 2014
  • 0 · Supplement · July 2, 2014
  • 0 · Supplement · February 21, 2014
  • 0 · Supplement · February 21, 2014
  • 0 · Supplement · February 21, 2014
  • 0 · Supplement · February 21, 2014
  • 0 · Supplement · February 21, 2014
  • 0 · Supplement · February 21, 2014
  • 0 · Original application · November 12, 2013
  • 0 · Original application · November 12, 2013
  • 0 · Supplement · November 8, 2013
  • 0 · Supplement · November 7, 2013
  • 0 · Original application · August 31, 2012

Adverse event reports

Source: openFDA FAERS
50,589
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: EVEROLIMUS. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
0078-0626-51 0078-0626 Novartis Pharmaceuticals Corporation 28 BLISTER PACK in 1 CARTON (0078-0626-51) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (0078-0626-61) August 29, 2012
0078-0627-51 0078-0627 Novartis Pharmaceuticals Corporation 28 BLISTER PACK in 1 CARTON (0078-0627-51) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (0078-0627-61) August 29, 2012
0078-0628-51 0078-0628 Novartis Pharmaceuticals Corporation 28 BLISTER PACK in 1 CARTON (0078-0628-51) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (0078-0628-61) August 29, 2012
0078-0626 0078-0626 Novartis Pharmaceuticals Corporation — August 29, 2012
0078-0627 0078-0627 Novartis Pharmaceuticals Corporation — August 29, 2012
0078-0628 0078-0628 Novartis Pharmaceuticals Corporation — August 29, 2012

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.