Quick answers
- What is Starjemza?
- Starjemza is a brand name of Ustekinumab, a prescription medicine. The FDA NDC Directory lists 4 Starjemza products in 3 strengths and forms.
- Who makes Starjemza?
- Bio-Thera Solutions Ltd holds the FDA application for Starjemza (BLA761419, approved May 22, 2025).
- Is there a generic or store brand of Starjemza?
- Other products of Ustekinumab are listed with the FDA, but none in exactly the same strength and form as a Starjemza product.
- Has Starjemza been recalled?
- No recall linked to Starjemza products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Starjemza is
Each Starjemza product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Ustekinumab · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| ustekinumab 130 mg/26 mL injection (intravenous) | Starjemza | None listed | DailyMed |
| ustekinumab 45 mg/0.5 mL injection (subcutaneous) | Starjemza | None listed | DailyMed |
| ustekinumab 90 mg/mL injection (subcutaneous) | Starjemza | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Ustekinumab →
FDA approval
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| BLA761419 | Bio-Thera Solutions Ltd | May 22, 2025 | 4 |
Companies that list Starjemza
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Starjemza products.
- Hikma Pharmaceuticals USA Inc.4 products
Recalls
No recall linked to Starjemza products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.