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Xtandi

enzalutamide · Capsule

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
Xtandi
Generic name
enzalutamide
Dosage form
Capsule
Route
Oral
Marketing category
NDA · NDA
Labeler
Astellas Pharma US, Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
2
Packages
2
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
Enzalutamide 40 mg/1 1307303 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Capsule
Route of administration
Oral
Presentations
4

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
Androgen Receptor Antagonists [MoA] MoA 5 members — no class page
Androgen Receptor Inhibitor [EPC] EPC 5 members — no class page
Cytochrome P450 2C19 Inducers [MoA] MoA All 37 members
Cytochrome P450 2C9 Inducers [MoA] MoA All 46 members
Cytochrome P450 3A4 Inducers [MoA] MoA All 54 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
203415
Application type
NDA · New Drug Application
Approval date
August 31, 2012
Sponsor
ASTELLAS
Products on application
1
Submissions recorded
21
Products approved under application 203415.
Product Trade name Form Strength Ingredient Status TE Flags
203415-001 XTANDI CAPSULE ENZALUTAMIDE 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.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
9126941 May 15, 2026 001 No U-2345 October 7, 2015
9126941 May 15, 2026 001 No U-1588 October 7, 2015
9126941 May 15, 2026 001 No U-2708 October 7, 2015
9126941 May 15, 2026 001 No U-3763 October 7, 2015
8183274 August 24, 2026 001 No U-1281 September 27, 2012
8183274 August 24, 2026 001 No U-1588 September 27, 2012
8183274 August 24, 2026 001 No U-2708 September 27, 2012
8183274 August 24, 2026 001 No U-2345 September 27, 2012
8183274 August 24, 2026 001 No U-3763 September 27, 2012
7709517 August 13, 2027 001 Yes September 27, 2012
12161628 February 23, 2037 001 No U-4101 January 8, 2025
12161628 February 23, 2037 001 No U-4102 January 8, 2025
12161628 February 23, 2037 001 No U-4103 January 8, 2025
12161628 February 23, 2037 001 No U-4104 January 8, 2025
Regulatory exclusivity periods.
Code Expires Product
I-926 November 17, 2026 001

Approval history

Source: Drugs@FDA
Most recent submissions on application 203415.
Type No. Action Status Date Review
Supplement 26 Efficacy Approved July 24, 2026 Standard
Supplement 25 Labeling Approved December 11, 2025 Standard
Supplement 24 Labeling Approved March 21, 2025 Standard
Supplement 23 Labeling Approved January 22, 2025 Standard
Supplement 22 Efficacy Approved November 16, 2023 Priority
Supplement 19 Efficacy Approved September 9, 2022 Standard
Supplement 18 Labeling Approved January 13, 2022 Standard
Supplement 16 Efficacy Approved October 23, 2020 Priority
Supplement 15 Efficacy Approved December 16, 2019 Priority
Supplement 14 Efficacy Approved July 13, 2018 Priority
Supplement 11 Efficacy Approved July 24, 2017 Standard
Supplement 9 Efficacy Approved October 20, 2016 Standard
Supplement 10 Manufacturing (CMC) Approved July 14, 2016 Priority
Supplement 8 Manufacturing (CMC) Approved November 6, 2015 Priority
Supplement 7 Labeling Approved October 1, 2015 Standard
Supplement 6 Labeling Approved August 5, 2015 Standard
Supplement 5 Efficacy Approved July 21, 2015 Standard
Supplement 3 Efficacy Approved September 10, 2014 Priority
Supplement 2 Manufacturing (CMC) Approved May 23, 2014 Priority
Supplement 1 Manufacturing (CMC) Approved March 19, 2013 Priority
Original application 1 Type 1 - New Molecular Entity Approved August 31, 2012 Priority

Review documents

  • 0 · Supplement · July 28, 2026
  • 0 · Supplement · July 27, 2026
  • 0 · Supplement · December 18, 2025
  • 0 · Supplement · December 12, 2025
  • 0 · Supplement · March 25, 2025
  • 0 · Supplement · March 24, 2025
  • 0 · Supplement · February 12, 2025
  • 0 · Supplement · February 7, 2025
  • 0 · Supplement · November 17, 2023
  • 0 · Supplement · November 17, 2023
  • 0 · Supplement · September 13, 2022
  • 0 · Supplement · September 12, 2022
  • 0 · Supplement · January 19, 2022
  • 0 · Supplement · January 18, 2022
  • 0 · Supplement · October 27, 2020
  • 0 · Supplement · October 27, 2020
  • 0 · Supplement · December 19, 2019
  • 0 · Supplement · December 16, 2019
  • 0 · Supplement · July 16, 2018
  • 0 · Supplement · July 13, 2018
  • 0 · Supplement · July 27, 2017
  • 0 · Supplement · July 25, 2017
  • 0 · Supplement · October 21, 2016
  • 0 · Supplement · October 20, 2016
  • 0 · Supplement · October 9, 2015
  • 0 · Supplement · October 8, 2015
  • 0 · Supplement · September 21, 2015
  • 0 · Supplement · August 10, 2015
  • 0 · Supplement · July 22, 2015
  • 0 · Supplement · July 22, 2015

Adverse event reports

Source: openFDA FAERS
58,437
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: ENZALUTAMIDE. 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
0469-0125-99 0469-0125 Astellas Pharma US, Inc. 1 BOTTLE in 1 CARTON (0469-0125-99) / 120 CAPSULE in 1 BOTTLE August 31, 2012
0469-1125-56 0469-1125 Astellas Pharma US, Inc. 56 CAPSULE in 1 BLISTER PACK (0469-1125-56) August 31, 2012
0469-0125 0469-0125 Astellas Pharma US, Inc. — August 31, 2012
0469-1125 0469-1125 Astellas Pharma US, Inc. — August 31, 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 · 12 sections on this page.