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Xalkori

Crizotinib · Capsule, Coated Pellets

Prescription NDA 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
Xalkori
Generic name
Crizotinib
Dosage form
Capsule, Coated Pellets
Route
Oral
Marketing category
NDA · NDA
Labeler
Pfizer Laboratories Div Pfizer Inc
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
Crizotinib 150 mg/1 1148498 View
Crizotinib 20 mg/1 1148498 View
Crizotinib 50 mg/1 1148498 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Capsule, Coated Pellets
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 2B6 Inhibitors [MoA] MoA 4 members — no class page
Cytochrome P450 3A Inhibitors [MoA] MoA All 89 members
Kinase Inhibitor [EPC] EPC All 89 members
Organic Cation Transporter 1 Inhibitors [MoA] MoA 3 members — no class page
Organic Cation Transporter 2 Inhibitors [MoA] MoA All 32 members
P-Glycoprotein Inhibitors [MoA] MoA All 105 members
Receptor Tyrosine Kinase Inhibitors [MoA] MoA 4 members — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
217581
Application type
NDA · New Drug Application
Approval date
September 7, 2023
Sponsor
PF PRISM CV
Products on application
3
Submissions recorded
1
Products approved under application 217581.
Product Trade name Form Strength Ingredient Status TE Flags
217581-001 XALKORI CAPSULE, PELLETS CRIZOTINIB Prescription — RLD
217581-002 XALKORI CAPSULE, PELLETS CRIZOTINIB Prescription — RLD
217581-003 XALKORI CAPSULE, PELLETS CRIZOTINIB Prescription — RLD RS

Therapeutic equivalence

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

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
7825137 May 12, 2027 001 No U-3057 October 6, 2023
7825137 May 12, 2027 001 No U-3403 October 6, 2023
7825137 May 12, 2027 001 No U-3058 October 6, 2023
7825137 May 12, 2027 002 No U-3057 October 6, 2023
7825137 May 12, 2027 002 No U-3058 October 6, 2023
7825137 May 12, 2027 002 No U-3403 October 6, 2023
7825137 May 12, 2027 003 No U-3403 October 6, 2023
7825137 May 12, 2027 003 No U-3057 October 6, 2023
7825137 May 12, 2027 003 No U-3058 October 6, 2023
7858643 October 8, 2029 001 Yes October 6, 2023
7858643 October 8, 2029 002 Yes October 6, 2023
7858643 October 8, 2029 003 Yes October 6, 2023
8217057 November 6, 2029 001 Yes October 6, 2023
8217057 November 6, 2029 002 Yes October 6, 2023
8217057 November 6, 2029 003 Yes October 6, 2023

Approval history

Source: Drugs@FDA
Most recent submissions on application 217581.
Type No. Action Status Date Review
Original application 1 Type 3 - New Dosage Form Approved September 7, 2023 Standard

Review documents

  • 0 · Original application · January 14, 2025
  • 0 · Original application · January 14, 2025
  • 0 · Original application · September 8, 2023
  • 0 · Original application · September 7, 2023

Adverse event reports

Source: openFDA FAERS
12,638
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: CRIZOTINIB. 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
0069-0251-60 0069-0251 Pfizer Laboratories Div Pfizer Inc 60 CAPSULE, COATED PELLETS in 1 BOTTLE (0069-0251-60) November 20, 2023
0069-0507-60 0069-0507 Pfizer Laboratories Div Pfizer Inc 60 CAPSULE, COATED PELLETS in 1 BOTTLE (0069-0507-60) November 20, 2023
0069-1500-60 0069-1500 Pfizer Laboratories Div Pfizer Inc 60 CAPSULE, COATED PELLETS in 1 BOTTLE (0069-1500-60) November 20, 2023
0069-0251 0069-0251 Pfizer Laboratories Div Pfizer Inc — November 20, 2023
0069-0507 0069-0507 Pfizer Laboratories Div Pfizer Inc — November 20, 2023
0069-1500 0069-1500 Pfizer Laboratories Div Pfizer Inc — November 20, 2023

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.