Quick answers
- What is Simponi Aria?
- Simponi Aria is a brand name of Golimumab, a prescription medicine. The FDA NDC Directory lists 1 Simponi Aria product in 1 strength and form.
- Who makes Simponi Aria?
- Janssen Biotech holds the FDA application for Simponi Aria (BLA125433, approved July 18, 2013).
- Is there a generic or store brand of Simponi Aria?
- Other products of Golimumab are listed with the FDA, but none in exactly the same strength and form as a Simponi Aria product.
- Has Simponi Aria been recalled?
- No recall linked to Simponi Aria products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Simponi Aria is
Each Simponi Aria 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.
Golimumab · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| golimumab 50 mg/4 mL solution (intravenous) | Simponi Aria | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Golimumab →
FDA approval
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| BLA125433 | Janssen Biotech | July 18, 2013 | 1 |
Companies that list Simponi Aria
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Simponi Aria products.
- Janssen Biotech, Inc.1 product
Recalls
No recall linked to Simponi Aria 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.