Quick answers
- What is Ustekinumab used for?
- The FDA-approved label (Stelara, Janssen Biotech, Inc., September 8, 2026) says: “STELARA is a human interleukin-12 and -23 antagonist indicated for the treatment of: Moderate to severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. Active psoriatic arthritis in adults and pediatric patients 6 years of age and older. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ustekinumab have a boxed warning?
- No. None of the 8 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Ustekinumab?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Ustekinumab been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Ustekinumab?
- 10 companies list prescription products of Ustekinumab in the FDA NDC Directory, including Nuvaila Limited, Janssen Biotech, Inc. and Fresenius Kabi USA, LLC.
What Ustekinumab is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
STELARA is a human interleukin-12 and -23 antagonist indicated for the treatment of: Moderate to severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. Active psoriatic arthritis in adults and pediatric patients 6 years of age and older. …
— FDA label: Stelara, Janssen Biotech, Inc., effective September 8, 2026. Read the full label on DailyMed →
The FDA has 8 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 8 FDA labels for this medicine have a boxed warning.
Forms and how it is given
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| ustekinumab 45 mg/0.5 mL injection, solution | Brand: Stelara | $29,874.45 per mL |
| ustekinumab 45 mg/0.5 mL injection, solution | Brand: Yesintek | $2,855.57 per mL |
| ustekinumab 90 mg/mL injection, solution | Brand: Pyzchiva | $4,039.78 per mL |
| ustekinumab 90 mg/mL injection, solution | Brand: Stelara | $29,792.79 per mL |
| ustekinumab 90 mg/mL injection, solution | Brand: Steqeyma | $3,936.94 per mL |
| ustekinumab 90 mg/mL injection, solution | Brand: Yesintek | $2,903.40 per mL |
NADAC list of November 4, 2026; these prices took effect between September 23, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Nuvaila Limited7 products
- Janssen Biotech, Inc.6 products
- Fresenius Kabi USA, LLC6 products
- Hikma Pharmaceuticals USA Inc.4 products
- CELLTRION USA, Inc.4 products
- Quallent Pharmaceuticals Health LLC4 products
- Biocon Biologics Inc.4 products
- Sandoz Inc3 products
- Cordavis Limited2 products
- A-S Medication Solutions1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA125261 STELARA | Centocor Ortho Biotech Inc | September 25, 2009 | 31, latest August 28, 2026 2026: Labeling · 2026: Labeling · 2026: Labeling |
| BLA761044 STELARA | Janssen Biotech | September 23, 2016 | 15, latest August 28, 2026 2026: Efficacy · 2026: Labeling · 2026: Efficacy |
| BLA761285 WEZLANA | Amgen Inc | October 31, 2023 | 3, latest May 12, 2026 2026: BIOSIMILAR · 2025: Labeling · 2024: Efficacy |
| BLA761331 WEZLANA | Amgen Inc | October 31, 2023 | 3, latest May 12, 2026 2026: BIOSIMILAR · 2025: Labeling · 2024: Labeling |
| BLA761338 STEQEYMA | Celltrion, Inc. | December 17, 2024 | 3, latest December 12, 2025 2025: Labeling · 2025: Labeling · 2025: Labeling |
| BLA761343 SELARSDI | Alvotech USA Inc | April 16, 2024 | 7, latest December 1, 2025 2025: BIOSIMILAR · 2025: Labeling · 2025: Supplement |
| BLA761373 PYZCHIVA | Samsung Bioepis Co Ltd | June 28, 2024 | 5, latest November 18, 2025 2025: Labeling · 2025: Manufacturing (CMC) · 2025: Supplement |
| BLA761379 OTULFI | Fresenius Kabi USA | September 27, 2024 | 7, latest January 15, 2026 2026: BIOSIMILAR · 2025: Labeling · 2025: Labeling |
| BLA761406 YESINTEK | Biocon Biologics Inc | November 29, 2024 | 2, latest August 14, 2026 2026: Efficacy · 2026: BIOSIMILAR |
| BLA761419 STARJEMZA | Bio-Thera Solutions Ltd | May 22, 2025 | — |
| BLA761425 PYZCHIVA | Samsung Bioepis Co Ltd | June 28, 2024 | 4, latest November 18, 2025 2025: Labeling · 2025: Labeling · 2024: Manufacturing (CMC) |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 853350, 853354, 853355, 853356, 1654077, 1654079, 1811255, 1811257, 2700393, 2700400 … (+10) |
|---|---|
| SPL set ID of the quoted label | c77a9664-e3bb-4023-b400-127aa53bca2b |
| FDA labels (SPL) | 8 |
| FDA applications | BLA125261, BLA761044, BLA761285, BLA761331, BLA761338, BLA761343, BLA761373, BLA761379, BLA761406, BLA761419, BLA761425 |
| Active ingredients (FDA) | USTEKINUMAB |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Stelara, Janssen Biotech, Inc., effective September 8, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →