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Simponi

golimumab · Injection, Solution

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
Simponi
Generic name
golimumab
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
8
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
Golimumab 100 mg/mL 1431642 —
Golimumab 50 mg/.5mL 1431642 —

Forms, strengths and routes

Source: NDC Directory
Dosage form
Injection, Solution
Route of administration
Subcutaneous
Presentations
10

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
Tumor Necrosis Factor Blocker [EPC] EPC All 10 members
Tumor Necrosis Factor Receptor Blocking Activity [MoA] MoA All 10 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
125289
Application type
BLA · Biologics License Application
Approval date
April 24, 2009
Sponsor
CENTOCOR ORTHO BIOTECH INC
Products on application
1
Submissions recorded
33
Products approved under application 125289.
Product Trade name Form Strength Ingredient Status TE Flags
125289-001 SIMPONI INJECTABLE GOLIMUMAB Prescription —

Approval history

Source: Drugs@FDA
Most recent submissions on application 125289.
Type No. Action Status Date Review
Supplement 158 Labeling Approved October 22, 2025 Standard
Supplement 157 Efficacy Approved October 7, 2025 Standard
Supplement 156 Labeling Approved October 1, 2025 Standard
Supplement 155 Labeling Approved April 18, 2025 Standard
Supplement 153 Labeling Approved November 16, 2023 Standard
Supplement 150 Labeling Approved March 30, 2023 Standard
Supplement 146 Labeling Approved September 24, 2019 Standard
Supplement 139 Labeling Approved March 6, 2018 Standard
Supplement 141 Labeling Approved February 9, 2018 Standard
Supplement 137 Labeling Approved November 13, 2017 Standard
Supplement 133 Efficacy Approved June 22, 2017 Standard
Supplement 135 Labeling Approved January 30, 2017 Standard
Supplement 127 Labeling Approved January 8, 2016 Standard
Supplement 124 Labeling Approved June 16, 2015 Standard
Supplement 121 Labeling Approved December 19, 2014 Standard
Supplement 105 Efficacy Approved January 24, 2014 Standard
Supplement 103 Labeling Approved December 27, 2013 Standard
Supplement 94 Labeling Approved November 13, 2013 Standard
Supplement 79 Efficacy Approved May 15, 2013 Standard
Supplement 78 Efficacy Approved May 15, 2013 Standard
Supplement 77 Efficacy Approved May 15, 2013 Standard
Supplement 86 Labeling Approved May 6, 2013 Standard
Supplement 84 Labeling Approved April 23, 2013 Standard
Supplement 70 Labeling Approved November 23, 2012 Standard
Supplement 64 Labeling Approved December 26, 2011 Standard
Supplement 53 Labeling Approved September 7, 2011 Standard
Supplement 38 Labeling Approved August 17, 2011 Standard
Supplement 20 Labeling Approved March 17, 2011 Standard
Supplement 29 Labeling Approved December 22, 2010 Standard
Supplement 33 Labeling Approved September 29, 2010 Standard
Supplement 25 Labeling Approved July 29, 2010 Standard
Supplement 6 Labeling Approved November 18, 2009 Standard
Original application 1 Type 1 - New Molecular Entity Approved April 24, 2009 Standard

Review documents

  • 0 · Supplement · June 8, 2026
  • 0 · Supplement · October 23, 2025
  • 0 · Supplement · October 23, 2025
  • 0 · Supplement · October 23, 2025
  • 0 · Supplement · October 7, 2025
  • 0 · Supplement · October 7, 2025
  • 0 · Supplement · October 3, 2025
  • 0 · Supplement · October 1, 2025
  • 0 · Supplement · July 11, 2025
  • 0 · Supplement · April 25, 2025
  • 0 · Supplement · November 17, 2023
  • 0 · Supplement · March 31, 2023
  • 0 · Supplement · March 31, 2023
  • 0 · Supplement · September 25, 2019
  • 0 · Supplement · September 25, 2019
  • 0 · Supplement · March 12, 2018
  • 0 · Supplement · March 8, 2018
  • 0 · Supplement · February 9, 2018
  • 0 · Supplement · February 9, 2018
  • 0 · Supplement · November 15, 2017
  • 0 · Supplement · November 14, 2017
  • 0 · Supplement · June 22, 2017
  • 0 · Supplement · June 22, 2017
  • 0 · Supplement · May 17, 2017
  • 0 · Supplement · January 31, 2017
  • 0 · Supplement · January 30, 2017
  • 0 · Supplement · January 12, 2016
  • 0 · Supplement · January 11, 2016
  • 0 · Supplement · June 19, 2015
  • 0 · Supplement · June 18, 2015

Adverse event reports

Source: openFDA FAERS
85,260
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: GOLIMUMAB. 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
57894-070-01 57894-070 Janssen Biotech, Inc. 1 SYRINGE, GLASS in 1 CARTON (57894-070-01) / .5 mL in 1 SYRINGE, GLASS April 25, 2009
57894-070-02 57894-070 Janssen Biotech, Inc. 1 SYRINGE in 1 CARTON (57894-070-02) / .5 mL in 1 SYRINGE April 25, 2009
57894-070-89 57894-070 Janssen Biotech, Inc. 1 SYRINGE in 1 CARTON (57894-070-89) / .5 mL in 1 SYRINGE April 25, 2009
57894-070-90 57894-070 Janssen Biotech, Inc. 1 SYRINGE, GLASS in 1 CARTON (57894-070-90) / .5 mL in 1 SYRINGE, GLASS April 25, 2009
57894-071-01 57894-071 Janssen Biotech, Inc. 1 SYRINGE, GLASS in 1 CARTON (57894-071-01) / 1 mL in 1 SYRINGE, GLASS May 15, 2013
57894-071-02 57894-071 Janssen Biotech, Inc. 1 SYRINGE in 1 CARTON (57894-071-02) / 1 mL in 1 SYRINGE May 15, 2013
57894-071-89 57894-071 Janssen Biotech, Inc. 1 SYRINGE in 1 CARTON (57894-071-89) / 1 mL in 1 SYRINGE May 15, 2013
57894-071-90 57894-071 Janssen Biotech, Inc. 1 SYRINGE, GLASS in 1 CARTON (57894-071-90) / 1 mL in 1 SYRINGE, GLASS May 15, 2013
57894-070 57894-070 Janssen Biotech, Inc. — April 25, 2009
57894-071 57894-071 Janssen Biotech, Inc. — May 15, 2013

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 · 9 sections on this page.