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Brand-name prescription medicine

Selarsdi

Generic names: Ustekinumab-aekn · Ustekinumab

FDA application holder: Alvotech USA Inc

Official data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the NDC Directory, Drugs@FDA, the official labels and recall reports; pharmacy costs come from the Centers for Medicare & Medicaid Services (CMS). Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or switch any medicine, including a switch between a brand and a generic.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

Quick answers

What is Selarsdi?
Selarsdi is a brand name of Ustekinumab-aekn and Ustekinumab, a prescription medicine. The FDA NDC Directory lists 4 Selarsdi products in 4 strengths and forms.
Who makes Selarsdi?
Alvotech USA Inc holds the FDA application for Selarsdi (BLA761343, approved April 16, 2024). 1 other company (repackagers or distributors) also list Selarsdi products.
Is there a generic or store brand of Selarsdi?
Yes. The FDA NDC Directory lists 15 other products with the same active ingredients, strength and form as a Selarsdi product. Ask your pharmacist whether one is right for you.
Has Selarsdi been recalled?
No recall linked to Selarsdi products (by their NDC code or label) appears in the FDA enforcement reports we use.

What Selarsdi is

Each Selarsdi 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-aekn · prescription medicine

Strength and formProduct namesSame medicine, other namesLabel
ustekinumab-aekn 130 mg/26 mL
injection, solution (intravenous)
Selarsdi None listed DailyMed
ustekinumab-aekn 45 mg/0.5 mL
injection, solution (subcutaneous)
Selarsdi 2 products, 1 company DailyMed
ustekinumab-aekn 90 mg/mL
injection, solution (subcutaneous)
Selarsdi 2 products, 1 company DailyMed

Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Ustekinumab-aekn →

Ustekinumab · prescription medicine

Strength and formProduct namesSame medicine, other namesLabel
ustekinumab 90 mg/mL
injection, solution (subcutaneous)
Selarsdi 11 products, 8 companies 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.
FDA applications of Selarsdi products (Drugs@FDA)
ApplicationHolderFirst approvedProducts
BLA761343Alvotech USA IncApril 16, 20244

Companies that list Selarsdi

The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Selarsdi products.

Recalls

No recall linked to Selarsdi products (by their NDC code or label) appears in the FDA enforcement reports.

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. 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.

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