Prescription medicine
Ustekinumab-srlf Brand names: Imuldosa
Ustekinumab-srlf (Imuldosa) is a prescription medicine with an FDA approval on record since 2024. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the ustekinumab-srlf FDA label on DailyMed (effective June 17, 2026); the BLA 761364 record on Drugs@FDA; every ustekinumab-srlf label on DailyMed.
Highlights of the record
FDA label of June 17, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageIMULDOSA is a human interleukin-12 and -23 antagonist indicated for the treatment of: Adult patients with: moderate to severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy.
Forms and strengths
- 45 mg/.5ml
- 90 mg/ml
- 130 mg/26ml
Injection.
On the market
- Earliest approval on file
- October 10, 2024 Imuldosa, Accord Biopharma Inc.; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2026 0 Class I among all firms' recalls; latest June 10, 2026
- FAERS reports
- 2 through July 30, 2026
What is ustekinumab-srlf used for?
From the label: indications and usageIMULDOSA is a human interleukin-12 and -23 antagonist indicated for the treatment of: Adult patients with: moderate to severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. (1.1) active psoriatic arthritis in adult and pediatric patients 6 years of age and older. (1.2) moderately to severely active Crohn’s disease in adult patients. (1.3) moderately to severely active ulcerative colitis in adult patients. […]
Conditions named in the indications of ustekinumab-srlf's FDA labels, with every medicine labeled for each:
From other ustekinumab-srlf labelsCrohn's disease and ulcerative colitis: Crohn’s Disease (CD) IMULDOSA is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease.
FDA pharmacologic class: Interleukin-12 Antagonist and Interleukin-23 Antagonist.
Source: FDA drug label (IMULDOSA), Accord BioPharma Inc., effective June 17, 2026 (SPL set 2539a6cf-0fe5-1565-e063-6294a90a3618), via openFDA; the full label on DailyMed
What does the patient leaflet for ustekinumab-srlf say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about IMULDOSA?IMULDOSA is a medicine that affects your immune system. IMULDOSA can increase your risk of having serious side effects, including: Serious infections. IMULDOSA may lower the ability of your immune system to fight infections and may increase your risk of infections. Some people have serious infections during treatment with ustekinumab products, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses. Some people have to be hospitalized for treatment of their infection. Your healthcare provider should check you for TB before starting IMULDOSA. If your healthcare provider feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with IMULDOSA and during treatment with IMULDOSA. Your healthcare provider should watch you closely for signs and symptoms of TB while you are being treated with IMULDOSA. You should not start IMULDOSA if you have any kind of infection unless your healthcare provider says it is okay. Before starting IMULDOSA, tell your doctor if you: think you have an infection or have symptoms of an infection such as: fever, sweat, or chills muscle aches cough shortness of breath blood in phlegm weight loss warm, red, or painful skin or sores on your body diarrhea or stomach pain burning when you urinate or urinate more often than normal feel very tired are being treated for an infection or have any open cuts. get a lot of infections or have infections that keep coming back. have TB, or have been in close contact with someone with TB. After starting IMULDOSA, call your doctor right away if you have any symptoms of an infection (see above). These may be signs of infections such as chest infections, or skin infections or shingles that could have serious complications. […]
From the patient leaflet: What should I avoid while using IMULDOSA?You should not receive a live vaccine while taking IMULDOSA. See “Before you receive IMULDOSA, tell your healthcare provider about all of your medical conditions, including if you:”
From the patient leaflet: How should I store IMULDOSA?Store IMULDOSA vials and prefilled syringes in a refrigerator between 36°F to 46°F (2°C to 8°C). Store IMULDOSA vials standing up straight. Store IMULDOSA in the original carton to protect it from light until time to use it. Do not freeze IMULDOSA. Do not shake IMULDOSA. If needed, individual IMULDOSA prefilled syringes may also be stored at room temperature up to 86ºF (30°C) for a maximum single period of up to 30 days in the original carton to protect from light. Record the date when the prefilled syringe is first removed from the refrigerator on the carton in the space provided. After a prefilled syringe has been stored at room temperature, do not return it to the refrigerator. Throw away (discard) the prefilled syringe if it is not used within 30 days at room temperature storage. Do not use IMULDOSA after the expiration date on the carton or on the prefilled syringe. […]
Source: FDA drug label (IMULDOSA), Accord BioPharma Inc., effective June 17, 2026 (SPL set 2539a6cf-0fe5-1565-e063-6294a90a3618), via openFDA; the full label on DailyMed
Is there a generic for ustekinumab-srlf (Imuldosa)?
No generic ustekinumab-srlf is approved (Drugs@FDA, October 8, 2026).
- 2024 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has ustekinumab-srlf been recalled?
The FDA's Enforcement Report lists 1 recall naming ustekinumab-srlf since 2026: 0 Class I (the most serious), 1 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 10, 2026 | Class II | ACCORD BIOPHARMA INC | Lack of assurance of Sterility: |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the ustekinumab-srlf label say about other medicines?
The ustekinumab-srlf label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Ustekinumab | contraindications | CONTRAINDICATIONS IMULDOSA is contraindicated in patients with clinically significant hypersensitivity to Ustekinumab products or to any of the excipients in IMULDOSA [ see Warnings and Precautions ( 5.5 ) ]. |
Source: FDA drug label (IMULDOSA), Accord BioPharma Inc., effective June 17, 2026 (SPL set 2539a6cf-0fe5-1565-e063-6294a90a3618), via openFDA; the full label on DailyMed
What do FAERS reports show for ustekinumab-srlf?
The FDA Adverse Event Reporting System holds 2 reports that list ustekinumab-srlf among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 0 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as ustekinumab-srlf?
4 other medicines are given the same way (subcutaneous) and in the same FDA class as ustekinumab-srlf or labeled mainly for the same use (crohn's disease and ulcerative colitis), the same class first. Crohn's disease and ulcerative colitis lists all 29 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (subcutaneous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Ustekinumab | Crohn's disease and ulcerative colitis | none listed | $29,874.45 per mL 45 mg/0.5 mL syringe | No current entry |
| Ustekinumab-aekn | Crohn's disease and ulcerative colitis | none listed | n/a | No current entry |
| Risankizumab | Crohn's disease and ulcerative colitis | none listed | $22,774.36 per mL 150 mg/mL pen | No current entry |
| Guselkumab | Crohn's disease and ulcerative colitis | none listed | $14,728.91 per mL 100 mg/mL syringe | No current entry |
Every medicine labeled for the same conditions as ustekinumab-srlf
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to ustekinumab-srlf
- 4 medicines for the same use
- Other interleukin-12 antagonists
- the pharmacologic class, with prices and generics
- Ustekinumab-srlf side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other