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XELJANZ

tofacitinib · Tablet, Film Coated, Extended Release

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
XELJANZ XR
Generic name
tofacitinib
Dosage form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing category
NDA · NDA
Labeler
Pfizer Laboratories Div Pfizer Inc
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
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
Tofacitinib Citrate 11 mg/1 1357541 View
Tofacitinib Citrate 22 mg/1 1357541 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Film Coated, Extended Release
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
Janus Kinase Inhibitor [EPC] EPC All 15 members
Janus Kinase Inhibitors [MoA] MoA All 15 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
208246
Application type
NDA · New Drug Application
Approval date
February 23, 2016
Sponsor
PFIZER
Products on application
2
Submissions recorded
17
Products approved under application 208246.
Product Trade name Form Strength Ingredient Status TE Flags
208246-001 XELJANZ XR TABLET, EXTENDED RELEASE TOFACITINIB CITRATE Prescription AB RLD
208246-002 XELJANZ XR TABLET, EXTENDED RELEASE TOFACITINIB CITRATE 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
RE41783 December 8, 2025 001 Yes March 18, 2016
RE41783 December 8, 2025 002 Yes January 9, 2020
RE41783*PED June 8, 2026 001 No —
RE41783*PED June 8, 2026 002 No —
11253523 March 14, 2034 001 No U-3326 March 23, 2022
11253523 March 14, 2034 001 No U-3327 March 23, 2022
11253523 March 14, 2034 001 No U-3328 March 23, 2022
11253523 March 14, 2034 001 No U-3329 March 23, 2022
9937181 March 14, 2034 001 No May 9, 2018
11253523 March 14, 2034 002 No U-3326 March 23, 2022
11253523 March 14, 2034 002 No U-3327 March 23, 2022
11253523 March 14, 2034 002 No U-3328 March 23, 2022
11253523 March 14, 2034 002 No U-3329 March 23, 2022
10639309 March 14, 2034 002 No June 3, 2020
9937181*PED September 14, 2034 001 No —
11253523*PED September 14, 2034 001 No —
10639309*PED September 14, 2034 002 No —
11253523*PED September 14, 2034 002 No —

Approval history

Source: Drugs@FDA
Most recent submissions on application 208246.
Type No. Action Status Date Review
Supplement 28 Labeling Approved September 16, 2026 Standard
Supplement 29 Labeling Approved June 30, 2026 Standard
Supplement 27 Efficacy Approved March 6, 2026 Standard
Supplement 25 Efficacy Approved February 21, 2025 Standard
Supplement 23 Labeling Approved September 27, 2024 Standard
Supplement 21 Labeling Approved May 14, 2024 Standard
Supplement 13 Efficacy Approved December 14, 2021 Standard
Supplement 17 Labeling Approved December 2, 2021 Standard
Supplement 9 Efficacy Approved December 12, 2019 Standard
Supplement 11 Labeling Approved August 30, 2019 Standard
Supplement 10 Labeling Approved July 25, 2019 Standard
Supplement 6 Labeling Approved October 18, 2018 Standard
Supplement 7 Labeling Approved August 17, 2018 Standard
Supplement 3 Efficacy Approved December 14, 2017 Standard
Supplement 2 Labeling Approved August 22, 2017 Standard
Supplement 1 Efficacy Approved August 22, 2017 Standard
Original application 1 Type 3 - New Dosage Form Approved February 23, 2016 Standard

Review documents

  • 0 · Supplement · September 22, 2026
  • 0 · Supplement · September 22, 2026
  • 0 · Supplement · September 21, 2026
  • 0 · Supplement · July 6, 2026
  • 0 · Supplement · July 2, 2026
  • 0 · Supplement · March 11, 2026
  • 0 · Supplement · March 9, 2026
  • 0 · Supplement · February 25, 2025
  • 0 · Supplement · February 24, 2025
  • 0 · Supplement · September 30, 2024
  • 0 · Supplement · September 27, 2024
  • 0 · Supplement · May 20, 2024
  • 0 · Supplement · May 15, 2024
  • 0 · Supplement · December 16, 2021
  • 0 · Supplement · December 15, 2021
  • 0 · Supplement · December 6, 2021
  • 0 · Supplement · December 3, 2021
  • 0 · Supplement · December 13, 2019
  • 0 · Supplement · December 13, 2019
  • 0 · Supplement · September 12, 2019
  • 0 · Supplement · August 30, 2019
  • 0 · Supplement · July 29, 2019
  • 0 · Supplement · July 26, 2019
  • 0 · Supplement · October 23, 2018
  • 0 · Supplement · October 19, 2018
  • 0 · Supplement · August 21, 2018
  • 0 · Supplement · August 20, 2018
  • 0 · Supplement · December 15, 2017
  • 0 · Supplement · December 15, 2017
  • 0 · Supplement · August 24, 2017

Adverse event reports

Source: openFDA FAERS
13,034
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: TOFACITINIB CITRATE. 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
0069-0501-30 0069-0501 Pfizer Laboratories Div Pfizer Inc 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0069-0501-30) March 7, 2016
0069-0502-30 0069-0502 Pfizer Laboratories Div Pfizer Inc 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0069-0502-30) January 21, 2020
0069-0501 0069-0501 Pfizer Laboratories Div Pfizer Inc — March 7, 2016
0069-0502 0069-0502 Pfizer Laboratories Div Pfizer Inc — January 21, 2020

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.