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Skyrizi

risankizumab-rzaa · Injection

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
Skyrizi
Generic name
risankizumab-rzaa
Dosage form
Injection
Route
Intravenous
Marketing category
BLA · BLA
Labeler
AbbVie Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
5
Packages
8
Data completeness
58% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Risankizumab 150 mg/mL 797544 —
Risankizumab 180 mg/1.2mL 797544 —
Risankizumab 600 mg/10mL 797544 —

Forms, strengths and routes

Source: NDC Directory
Dosage form
Injection
Route of administration
Intravenous
Presentations
13

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

Regulatory status

Source: Drugs@FDANDC Directory
Application number
761105
Application type
BLA · Biologics License Application
Approval date
April 23, 2019
Sponsor
ABBVIE INC
Products on application
2
Submissions recorded
16
Products approved under application 761105.
Product Trade name Form Strength Ingredient Status TE Flags
761105-001 SKYRIZI INJECTABLE RISANKIZUMAB-RZAA Prescription —
761105-002 SKYRIZI INJECTABLE RISANKIZUMAB-RZAA Prescription —

Approval history

Source: Drugs@FDA
Most recent submissions on application 761105.
Type No. Action Status Date Review
Supplement 45 Efficacy Approved June 26, 2026 Standard
Supplement 44 Efficacy Approved June 12, 2026 Standard
Supplement 47 Labeling Approved March 18, 2026 Standard
Supplement 42 Efficacy Approved March 6, 2026 Standard
Supplement 39 Efficacy Approved September 3, 2025 Standard
Supplement 38 Labeling Approved May 7, 2025 Standard
Supplement 29 Efficacy Approved June 18, 2024 Standard
Supplement 27 Labeling Approved March 4, 2024 Standard
Supplement 32 Labeling Approved January 3, 2024 Standard
Supplement 18 Efficacy Approved September 23, 2022 Standard
Supplement 16 Efficacy Approved June 16, 2022 Priority
Supplement 14 Efficacy Approved January 21, 2022 Standard
Supplement 10 Efficacy Approved April 26, 2021 Standard
Supplement 9 Efficacy Approved April 26, 2021 Standard
Supplement 5 Labeling Approved March 20, 2020 Standard
Original application 1 Type 1 - New Molecular Entity Approved April 23, 2019 Standard

Review documents

  • 0 · Supplement · July 6, 2026
  • 0 · Supplement · June 30, 2026
  • 0 · Supplement · June 17, 2026
  • 0 · Supplement · June 16, 2026
  • 0 · Supplement · June 16, 2026
  • 0 · Supplement · March 24, 2026
  • 0 · Supplement · March 20, 2026
  • 0 · Supplement · March 12, 2026
  • 0 · Supplement · March 9, 2026
  • 0 · Supplement · September 5, 2025
  • 0 · Supplement · September 5, 2025
  • 0 · Supplement · September 4, 2025
  • 0 · Supplement · May 14, 2025
  • 0 · Supplement · June 20, 2024
  • 0 · Supplement · June 20, 2024
  • 0 · Supplement · April 15, 2024
  • 0 · Supplement · March 6, 2024
  • 0 · Supplement · March 5, 2024
  • 0 · Supplement · January 4, 2024
  • 0 · Supplement · January 4, 2024
  • 0 · Supplement · December 9, 2022
  • 0 · Supplement · December 9, 2022
  • 0 · Supplement · September 27, 2022
  • 0 · Supplement · September 26, 2022
  • 0 · Supplement · June 21, 2022
  • 0 · Supplement · June 17, 2022
  • 0 · Supplement · January 25, 2022
  • 0 · Supplement · January 25, 2022
  • 0 · Supplement · April 28, 2021
  • 0 · Supplement · April 28, 2021

Adverse event reports

Source: openFDA FAERS
81,290
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: RISANKIZUMAB. 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
0074-1050-01 0074-1050 AbbVie Inc. 1 SYRINGE in 1 CARTON (0074-1050-01) / 1 mL in 1 SYRINGE April 26, 2021
0074-1050-70 0074-1050 AbbVie Inc. 1 SYRINGE in 1 CARTON (0074-1050-70) / 1 mL in 1 SYRINGE April 26, 2021
0074-2100-01 0074-2100 AbbVie Inc. 1 SYRINGE in 1 CARTON (0074-2100-01) / 1 mL in 1 SYRINGE April 26, 2021
0074-2100-70 0074-2100 AbbVie Inc. 1 SYRINGE in 1 CARTON (0074-2100-70) / 1 mL in 1 SYRINGE April 26, 2021
0074-5015-01 0074-5015 AbbVie Inc. 1 VIAL, SINGLE-DOSE in 1 CARTON (0074-5015-01) / 10 mL in 1 VIAL, SINGLE-DOSE June 16, 2022
0074-5015-02 0074-5015 AbbVie Inc. 1 VIAL, SINGLE-DOSE in 1 CARTON (0074-5015-02) / 10 mL in 1 VIAL, SINGLE-DOSE June 16, 2022
0074-8300-01 0074-8300 AbbVie Inc. 1 SYRINGE in 1 CARTON (0074-8300-01) / 1.2 mL in 1 SYRINGE September 3, 2025
0074-8350-01 0074-8350 AbbVie Inc. 2 SYRINGE in 1 CARTON (0074-8350-01) / 1.2 mL in 1 SYRINGE September 3, 2025
0074-1050 0074-1050 AbbVie Inc. — April 26, 2021
0074-2100 0074-2100 AbbVie Inc. — April 26, 2021
0074-5015 0074-5015 AbbVie Inc. — June 16, 2022
0074-8300 0074-8300 AbbVie Inc. — September 3, 2025
0074-8350 0074-8350 AbbVie Inc. — September 3, 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.