What this pack is
Stelara is the brand name in this record; ustekinumab is the generic name. Read both together with the dosage form (injectable product).
PACK CHECK · MARKET FIRST
StelaraGeneric nameustekinumab
How this medicine works
The FDA STELARA label describes ustekinumab as specifically binding the p40 protein subunit shared by IL-12 and IL-23, disrupting their interaction with a shared receptor chain. It explains an immune-signalling pathway, not an individual's diagnosis, suitability, how intravenous induction and subcutaneous maintenance are sequenced, dose or medicine switch.
Read source: United States ↗reviewed 2026-08-20More about its action and precautions →Check the market, names, dosage form and route together
A medicine may use different brand names across markets. Keep the market, brand, generic name, dosage form and route together; one matching field does not prove that two packs are the same or interchangeable.
Open the complete product-identity record
Use these fields when the pack, market name or package image needs closer checking. They are evidence boundaries, not substitution instructions.
- International brand name
- Stelara
- Generic name
- ustekinumab
- Dosage-form class
- Dosage form and presentation as documented in the linked primary label
- Route
- Subcutaneous injection / intravenous infusion
- Package-image status
- A source-linked public label image is available below
No source-verifiable mainland-China trade-name cue has been established for this record. This does not establish whether the medicine exists, is approved or is available in mainland China. Check pack text and current CDE/NMPA records item by item.
FOR EVERYDAY QUESTIONS
After the leaflet, continue with the question you still need to check
What this page can show
This is a source-traceable public record. It helps you read the product identity and its listed source documents; each market still needs its own current record check.
What to bring to the next conversation
Bring the actual pack, the label or prescription, and a complete medicine list when you speak with a pharmacist or clinician.
NEXT SAFE STEP
Choose the next safe check
A question about changing, combining or splitting?Put the exact packs on one list before a pharmacist or prescriber checks the full context.Open the family medicine list →A question about cost, reimbursement or availability?First lock the market, exact presentation and date. Use local official reimbursement, hospital or pharmacy channels for a current answer rather than a web estimate.Open regulator and market-record entry points →Unsure about a pack or a cross-border product?Photo reading can return possible record matches only. Check the actual product against the current regulator record for its market.Identify pack text locally →Saw a recall, approval or procurement headline?Open the original publisher, then match its product, market and date. Do not make a stop or switch decision from a headline.Read primary-source news →
PRODUCT PRESENTATION IDENTITY
Strength, pack and device identity
A vial concentration, unit-per-mL value or device marking identifies the exact labelled product. It does not calculate an individual's amount, timing, administration, missed-use action, combination or switch.
The 45 mg vial, 45 mg prefilled syringe, 90 mg prefilled syringe and 130 mg intravenous vial are four separate product identities. A shared ingredient or milligram number does not create a syringe-to-vial, subcutaneous-to-intravenous, induction-to-maintenance or switching conversion.
4 source-backed strength, pack or device records — open the full list
First match the market, dosage form and labelled amount on the pack in hand. The number of tablets, sachets or devices in a pack is not a personal dose or schedule.
United States label · DailyMed U.S. public label (Janssen Biotech; updated Jul 2026)
Ustekinumab 45 mg/0.5 mL per single-dose vial; one per carton
- Product code
- NDC 57894-060-02
- Form and route
- STELARA ustekinumab single-dose vial · subcutaneous injection (label product-identity field)
- Labelled concentration
- 90 mg/mL (expressed by the labelled total and volume of this exact container)Product identity, not an individual dose
- Container
- single-dose glass vial for subcutaneous injection · 0.5 mL
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-28; actual marketing, stock and availability are not established.
- ustekinumab
- 45 mglabelled total per single-dose vial; not an individual's injection/infusion amount, frequency, conversion or switching plan
- Package
- 1 single-dose vial per carton
- Labelled appearance
- colourless to light-yellow solution that may contain a few small translucent or white particles (label description) · individually packaged single-dose vial and carton
United States label · DailyMed U.S. public label (Janssen Biotech; updated Jul 2026)
Ustekinumab 45 mg/0.5 mL per single-dose prefilled syringe; one per carton
- Product code
- NDC 57894-060-03
- Form and route
- STELARA ustekinumab single-dose prefilled syringe · subcutaneous injection (label product-identity field)
- Labelled concentration
- 90 mg/mL (expressed by the labelled total and volume of this exact container)Product identity, not an individual dose
- Container
- single-dose prefilled syringe with fixed 27-gauge, 1/2-inch needle and safety guard · 0.5 mL
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-28; actual marketing, stock and availability are not established.
- ustekinumab
- 45 mglabelled total per single-dose prefilled syringe; not an individual's injection/infusion amount, frequency, conversion or switching plan
- Package
- 1 single-dose prefilled syringe per carton
- Labelled appearance
- colourless to light-yellow solution that may contain a few small translucent or white particles (label description) · individually packaged single-dose prefilled syringe and carton
United States label · DailyMed U.S. public label (Janssen Biotech; updated Jul 2026)
Ustekinumab 90 mg/1 mL per single-dose prefilled syringe; one per carton
- Product code
- NDC 57894-061-03
- Form and route
- STELARA ustekinumab single-dose prefilled syringe · subcutaneous injection (label product-identity field)
- Labelled concentration
- 90 mg/mL (expressed by the labelled total and volume of this exact container)Product identity, not an individual dose
- Container
- single-dose prefilled syringe with fixed 27-gauge, 1/2-inch needle and safety guard · 1 mL
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-28; actual marketing, stock and availability are not established.
- ustekinumab
- 90 mglabelled total per single-dose prefilled syringe; not an individual's injection/infusion amount, frequency, conversion or switching plan
- Package
- 1 single-dose prefilled syringe per carton
- Labelled appearance
- colourless to light-yellow solution that may contain a few small translucent or white particles (label description) · individually packaged single-dose prefilled syringe and carton
United States label · DailyMed U.S. public label (Janssen Biotech; updated Jul 2026)
Ustekinumab 130 mg/26 mL (5 mg/mL) per single-dose vial; one per carton
- Product code
- NDC 57894-054-27
- Form and route
- STELARA ustekinumab single-dose vial · intravenous infusion after dilution (label identity only; not a procedure instruction)
- Labelled concentration
- 5 mg/mL (expressed by the labelled total and volume of this exact container)Product identity, not an individual dose
- Container
- single-dose vial for intravenous infusion · 26 mL
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-28; actual marketing, stock and availability are not established.
- ustekinumab
- 130 mglabelled total per single-dose vial; not an individual's injection/infusion amount, frequency, conversion or switching plan
- Package
- 1 single-dose vial per carton
- Labelled appearance
- colourless to light-yellow solution that may contain a few small translucent or white particles (label description) · individually packaged single-dose vial and carton
PUBLIC LABEL IMAGE
Appearance and package-text clues
This current public-label package panel helps check the brand, generic name, strength and dosage-form clues only. It does not authenticate a product in hand or establish originator status, availability, sale eligibility, another package or another market.
Open the public label source ↗LABEL READING · NOT A PRESCRIPTION
STELARA label reading: intravenous and subcutaneous products cannot be inferred from a shared name
Reading level: drug-specific label reading. This record has been expanded around its dosage form or a higher-risk reading question; the current target-market label and professional review still apply.
Using the current U.S. DailyMed public label for STELARA as an entry point, this checks ustekinumab, intravenous or subcutaneous route, package and target market; it does not turn a shared name, mg marking, infusion or injection wording into an individual dose, home handling or conversion plan.
- The label's 130 mg/26 mL (5 mg/mL) IV vial is an identity clue for that exact IV product; it does not establish that a subcutaneous product, another-market pack or another presentation is the same.
- Being an immune-related medicine, biologic or treatment for a related disease does not permit self-combination, alternation or substitution with another biologic, immunosuppressant, steroid, vaccine or infection treatment.
- With high fever, breathing trouble, severe abdominal pain, unusual neurologic symptoms, widespread rash or another acute concern, contact the local treatment team or urgent medical support promptly.
PHARMACOVIGILANCE · OFFICIAL ROUTES
Check safety information in the right market
Start with the public label or product record linked to this dossier, then use the official safety routes below for the market that applies to the medicine in hand.
Match five details before using a safety record
- Brand and generic nameBoth must match the medicine named by the record.
- Dosage form and strengthTablet, capsule, injection, inhaler, patch and eye drop are not interchangeable.
- Market and notice dateA record applies only to the country or region and date it names.
- Lot, pack and manufacturerRecord these only when the official notice specifically names them.
- Current product informationA historical record may have been superseded by the current label.
This checklist only helps organise the right question. It does not create a personal conclusion about stopping, switching, dose, combination or suitability.
This dossier’s product-level source checkU.S. National Library of Medicine DailyMed · United States · Public medicine label · 2026-08-20
This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk.
Markets actually represented by the reviewed product documents
- United States · 2
This is a document-coverage summary, not a claim that the medicine is authorised, supplied, interchangeable or actively monitored in every listed market today.
This record’s label or product-record routeDailyMed (NLM): current U.S. STELARA ustekinumab public label (Janssen Biotech; updated Jul 2026) ↗reviewed 2026-08-20
Other official market or version documents for this record
These are separately reviewed product documents for the same dossier. Their market, date, dosage form and document status must stay attached to each link; they do not establish interchangeability between products, strengths, packs, indications or countries.
- FDA · United States · Regulatory product record or label archive · 2026-08-20FDA: STELARA 2016 U.S. historical label (BLA 761044) ↗Historical public record · reviewed 2026-08-20
This is not a conclusion that the medicine has no risk, warning, recall or newer notice in another market. Start with the checked product-level label above, then use the official market gateways below for the product in hand.
See the reviewed safety-record directory →Global official safety gateways
- NMPA Centre for Drug Reevaluation · Mainland ChinaPrimary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item.Drug-vigilance bulletins and safety notices ↗reviewed 2026-08-22
- FDA · United StatesPrimary FDA pages for important new safety issues, labelling changes and risk communications.Drug Safety Communications ↗reviewed 2026-08-22
- FDA MedWatch · United StatesU.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality.Safety information and serious-problem reporting ↗reviewed 2026-08-22
- EMA · European Union / European Economic AreaOfficial EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment.Pharmacovigilance overview and EudraVigilance ↗reviewed 2026-08-22
- MHRA · United KingdomPrimary UK MHRA medicine-safety updates for professionals and the public.Drug Safety Update ↗reviewed 2026-08-22
- PMDA · JapanPMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents.Medicine safety information ↗reviewed 2026-08-22
- MFDS · Republic of KoreaMFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case.Medicine safety letters ↗reviewed 2026-08-22
- HSA · SingaporeHSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information.Adverse-event reporting and medicine-safety information ↗reviewed 2026-08-22
- Health Canada · CanadaHealth Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item.MedEffect Canada: advisories, warnings and recalls ↗reviewed 2026-08-22
- TGA · AustraliaPrimary Australian TGA safety alerts, advisories and monitoring information for therapeutic products.Medicine safety alerts ↗reviewed 2026-08-22
- Swissmedic · SwitzerlandOfficial Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality.Pharmacovigilance and suspected adverse-reaction reporting ↗reviewed 2026-08-22
- Medsafe · New ZealandNew Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information.Medicine safety communications ↗reviewed 2026-08-22
- SAHPRA · South AfricaSAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information.Medicine safety information, alerts and pharmacovigilance ↗reviewed 2026-08-22
- WHO · GlobalWHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market.Medicine and vaccine safety-alert archive ↗reviewed 2026-08-22
- Anvisa · BrazilAnvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item.Pharmacovigilance, alerts and VigiMed ↗reviewed 2026-08-22
This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline.
For severe or rapidly worsening symptoms, suspected overdose, a severe allergic reaction, loss of consciousness or another emergency, use local emergency services. Do not wait for an online alert search or change a medicine from this page.
PRIVATE FAMILY LIST
Bring this record into a local medicine list
Only the brand, generic name, dosage form and route are added, and they stay in this browser. Copy strength, label directions, start/stop history and any concern from the actual pack; this tool does not calculate a dose or decide combination, switching or stopping.
Add to the family medicine list →PACK · LABEL · MEDICINE LIST
Six checks for this medicine pack
Use this card to organise questions about Stelara (ustekinumab). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
Stelara is the brand in this record and ustekinumab is the active-ingredient name. Check both with the dosage form (Dosage form and presentation as documented in the linked primary label) and the market on the actual pack.
Read the labelled strength in context
mg/mL, mg per vial or a total volume describes the labelled concentration or pack identity of an injectable product. It is not an individual infusion amount, preparation instruction or schedule.
Check the exact injection presentation
For an injectable or infusion presentation, verify the route, concentration, container and device in the exact current label. Do not transfer, share, prepare or substitute it from this page.
Put every product on one list
Include prescriptions, over-the-counter products, eye drops, creams, vitamins, minerals, herbs and supplements. A pharmacist or prescriber needs the whole list before any combination, alternation, switch or stop is considered.
Ask a specific pharmacogenetics question
Ask which medicine, which gene and what clinical decision a result could change. A gene–drug association does not mean broad genetic testing is needed for everyone and must not be used to change treatment without professional review.
Know when to seek urgent help
For a severe reaction, fainting, difficulty breathing or sudden worsening symptoms around an injection or infusion, use the local treatment team or emergency service now. Do not wait for a website reply or alter preparation, infusion or another medicine yourself.
This card does not calculate a dose, decide whether medicines can be combined, or replace a clinician or pharmacist. Market-specific current labels and the person's full context still need review.
MARKET DOCUMENTS · READ SEPARATELY
Enlarged market leaflets and regulator documents
Each link retains its own market, date, dosage form and document status. These documents support larger-print reading and item-by-item checking; they do not make products, strengths, packs, indications or use between countries or regions interchangeable.
- DailyMed (NLM): current U.S. STELARA ustekinumab public label (Janssen Biotech; updated Jul 2026) ↗reviewed 2026-08-20
- FDA: STELARA 2016 U.S. historical label (BLA 761044) ↗Historical public record · reviewed 2026-08-20
HOW IT WORKS · NOT A TREATMENT PLAN
How ustekinumab works: the label describes binding the p40 subunit shared by IL-12 and IL-23
- “IL-12/23” or “targets inflammatory cytokines” is not a tool for identifying the cause of skin, joint or bowel symptoms, or deciding start, stop, delay, dose change or switching. Diagnosis, infection screening, disease activity, complete medicine list and current label need specialist assessment together.
- Subcutaneous products, intravenous products, another ustekinumab product or a different-market strength cannot be self-converted, interchanged or combined because of a shared mechanism. Route, concentration, one-time infusion plan and maintenance plan must be checked against the current label for the exact product.
- The label contains information about infection, allergy and other risks. With fever, persistent cough, breathing trouble, widespread rash, fainting or another acute severe concern, contact the local treatment team or urgent medical support promptly.
SOURCE EVIDENCE REGISTER
Source evidence map
Every public link is labelled with its market, document status and document type. A historical public record is not a current label, and an official lookup entry is not a product-specific record.
- DailyMed (NLM): current U.S. STELARA ustekinumab public label (Janssen Biotech; updated Jul 2026) ↗reviewed 2026-08-20
- FDA: STELARA 2016 U.S. historical label (BLA 761044) ↗Historical public record · reviewed 2026-08-20
- FDA Drugs@FDA official search entry ↗Official lookup entry · reviewed 2026-08-20
SOURCE-TRACEABLE ARCHIVE
Stelaraustekinumab
This page includes an exact current U.S. public-label package panel for Stelara, alongside documentary primary-source material. It helps check product identity, but does not itself establish originator status, product quality, availability or sale eligibility.
DOCUMENT TIMELINE
Document timeline
Dated current U.S. public-label record
This page links the current U.S. public label dated DailyMed SPL v22，2026-07 发布 as an enlarged-reading and item-by-item checking entry point. It does not replace same-day verification of approval, supply, indication, strength or individual use in the target market.
DailyMed: current STELARA U.S. public label ↗
MARKET SCOPE
Market-record boundary
United States
Current public label linkedOnly the U.S. public label listed on this page is linked; no stock, sale-eligibility or other-market conclusion is inferred.
Mainland China, EU, Japan
Market record not establishedNo local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. public label.
How to read this record
Read each document in its stated market, date and dosage-form context. A historical record is not a current label and does not support individual medical, substitution or purchasing conclusions.
Keep international and mainland China records separate
This page has a U.S. public history/regulatory archive but no mainland China record for this specific product. That does not establish whether the medicine exists, is approved or is available in mainland China. Verify product identity, dosage form, strength, holder and the current label item by item.
RECORD FAQ
Record questions
Does a current U.S. label represent another country or region?
No. It is an item-by-item reading entry point; brand, dosage form, strength, availability and safety information still require checking against the target market's current official document.
Why are price and originator/generic conclusions not shown?
Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient.
READ NEXT
Related reading
Evidence status
The listed links are public sources selected for traceability. They must be rechecked against the current target-market record before any use beyond reading and research.