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ustekinumab

Prescription Biologic BLA
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
ustekinumab
Generic name
ustekinumab
Dosage form
Injection, Solution
Route
Subcutaneous
Marketing category
BLA · BLA
Labeler
Janssen Biotech, Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
3
Data completeness
52% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Ustekinumab 45 mg/.5mL 2700669 View
Ustekinumab 90 mg/mL 2700669 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Injection, Solution
Route of administration
Subcutaneous
Presentations
5

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
Interleukin-12 Antagonist [EPC] EPC All 14 members
Interleukin-12 Antagonists [MoA] MoA All 14 members
Interleukin-23 Antagonist [EPC] EPC All 17 members
Interleukin-23 Antagonists [MoA] MoA All 17 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
125261
Application type
BLA · Biologics License Application
Approval date
September 25, 2009
Sponsor
CENTOCOR ORTHO BIOTECH INC
Products on application
2
Submissions recorded
32
Products approved under application 125261.
Product Trade name Form Strength Ingredient Status TE Flags
125261-001 STELARA INJECTABLE USTEKINUMAB Prescription —
125261-002 STELARA INJECTABLE USTEKINUMAB Prescription —

Approval history

Source: Drugs@FDA
Most recent submissions on application 125261.
Type No. Action Status Date Review
Supplement 173 Labeling Approved August 28, 2026 Standard
Supplement 174 Labeling Approved July 15, 2026 Standard
Supplement 172 Labeling Approved April 15, 2026 Standard
Supplement 171 Labeling Approved November 3, 2025 Standard
Supplement 167 Labeling Approved June 27, 2025 Standard
Supplement 168 Labeling Approved April 1, 2025 Standard
Supplement 166 Labeling Approved November 15, 2024 Standard
Supplement 163 Labeling Approved March 18, 2024 Standard
Supplement 158 Labeling Approved March 6, 2023 Standard
Supplement 161 Efficacy Approved July 29, 2022 Standard
Supplement 157 Labeling Approved December 11, 2020 Standard
Supplement 154 Labeling Approved December 1, 2020 Standard
Supplement 150 Efficacy Approved July 29, 2020 Standard
Supplement 153 Labeling Approved April 6, 2020 Standard
Supplement 142 Labeling Approved November 7, 2019 Standard
Supplement 152 Labeling Approved October 18, 2019 Standard
Supplement 147 Labeling Approved June 8, 2018 901 Required
Supplement 141 Labeling Approved February 16, 2018 Standard
Supplement 138 Efficacy Approved October 13, 2017 Standard
Supplement 129 Approved February 15, 2017 Standard
Supplement 114 Labeling Approved March 4, 2014 Standard
Supplement 103 Efficacy Approved September 20, 2013 Standard
Supplement 86 Efficacy Approved May 21, 2013 Standard
Supplement 99 Labeling Approved April 29, 2013 Standard
Supplement 91 Labeling Approved January 25, 2013 Standard
Supplement 59 Labeling Approved June 14, 2012 Standard
Supplement 49 Efficacy Approved May 31, 2012 Standard
Supplement 63 Labeling Approved May 2, 2012 Standard
Supplement 58 Labeling Approved April 6, 2012 Standard
Supplement 13 Labeling Approved October 20, 2010 Standard
Supplement 1 Efficacy Approved December 30, 2009 Standard
Original application 1 Type 1 - New Molecular Entity Approved September 25, 2009 Standard

Review documents

  • 0 · Supplement · September 1, 2026
  • 0 · Supplement · September 1, 2026
  • 0 · Supplement · July 29, 2026
  • 0 · Supplement · July 29, 2026
  • 0 · Supplement · July 16, 2026
  • 0 · Supplement · April 20, 2026
  • 0 · Supplement · April 16, 2026
  • 0 · Supplement · November 4, 2025
  • 0 · Supplement · November 4, 2025
  • 0 · Supplement · November 4, 2025
  • 0 · Supplement · July 3, 2025
  • 0 · Supplement · June 30, 2025
  • 0 · Supplement · April 8, 2025
  • 0 · Supplement · April 2, 2025
  • 0 · Supplement · November 19, 2024
  • 0 · Supplement · November 18, 2024
  • 0 · Supplement · March 21, 2024
  • 0 · Supplement · March 19, 2024
  • 0 · Supplement · March 7, 2023
  • 0 · Supplement · March 7, 2023
  • 0 · Supplement · August 2, 2022
  • 0 · Supplement · August 1, 2022
  • 0 · Supplement · December 15, 2020
  • 0 · Supplement · December 2, 2020
  • 0 · Supplement · December 1, 2020
  • 0 · Supplement · July 30, 2020
  • 0 · Supplement · July 30, 2020
  • 0 · Supplement · April 7, 2020
  • 0 · Supplement · November 20, 2019
  • 0 · Supplement · November 14, 2019

Adverse event reports

Source: openFDA FAERS
102,265
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: USTEKINUMAB. 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
57894-440-01 57894-440 Janssen Biotech, Inc. 1 SYRINGE in 1 CARTON (57894-440-01) / .5 mL in 1 SYRINGE April 1, 2025
57894-440-03 57894-440 Janssen Biotech, Inc. 1 VIAL, SINGLE-USE in 1 CARTON (57894-440-03) / .5 mL in 1 VIAL, SINGLE-USE April 1, 2025
57894-441-01 57894-441 Janssen Biotech, Inc. 1 SYRINGE in 1 CARTON (57894-441-01) / 1 mL in 1 SYRINGE April 1, 2025
57894-440 57894-440 Janssen Biotech, Inc. — April 1, 2025
57894-441 57894-441 Janssen Biotech, Inc. — April 1, 2025

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
FAERS FDA Adverse event report counts
Purple Book FDA Biologic licence classification

Generated September 25, 2026 · 10 sections on this page.