Quick answers
- What is Amjevita?
- Amjevita is a brand name of Adalimumab-atto, a prescription medicine. The FDA NDC Directory lists 18 Amjevita products in 6 strengths and forms.
- Who makes Amjevita?
- Amgen Inc holds the FDA application for Amjevita (BLA761024, approved September 23, 2016). 2 other companies (repackagers or distributors) also list Amjevita products.
- Is there a generic or store brand of Amjevita?
- Other products of Adalimumab-atto are listed with the FDA, but none in exactly the same strength and form as a Amjevita product.
- Has Amjevita been recalled?
- No recall linked to Amjevita products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Amjevita is
Each Amjevita 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.
Adalimumab-atto · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| adalimumab 10 mg/0.2 mL injection (subcutaneous) | Amjevita | None listed | DailyMed |
| adalimumab 20 mg/0.2 mL injection (subcutaneous) | Amjevita | None listed | DailyMed |
| adalimumab 20 mg/0.4 mL injection (subcutaneous) | Amjevita | None listed | DailyMed |
| adalimumab 40 mg/0.4 mL injection (subcutaneous) | Amjevita | None listed | DailyMed |
| adalimumab 40 mg/0.8 mL injection (subcutaneous) | Amjevita | None listed | DailyMed |
| adalimumab 80 mg/0.8 mL injection (subcutaneous) | Amjevita | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Adalimumab-atto →
FDA approval
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
Companies that list Amjevita
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Amjevita products.
- Amgen, Inc9 products
- Amgen USA Inc.5 products
- Nuvaila Limited4 products
Recalls
No recall linked to Amjevita 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.