Quick answers
- What is Ofev?
- Ofev is a brand name of Nintedanib, a prescription medicine. The FDA NDC Directory lists 2 Ofev products in 2 strengths and forms.
- Who makes Ofev?
- Boehringer Ingelheim holds the FDA application for Ofev (NDA205832, approved October 15, 2014).
- Is there a generic or store brand of Ofev?
- Yes. The FDA NDC Directory lists 22 other products with the same active ingredients, strength and form as a Ofev product, 22 of them generic. Ask your pharmacist whether one is right for you.
- Has Ofev been recalled?
- No recall linked to Ofev products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Ofev is
Each Ofev 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.
Nintedanib · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| nintedanib esylate 100 mg capsule (oral) | Ofev | 11 products, 11 companies | DailyMed |
| nintedanib esylate 150 mg capsule (oral) | Ofev | 11 products, 11 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Nintedanib →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA205832 | Boehringer Ingelheim | October 15, 2014 | 2 |
Companies that list Ofev
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Ofev products.
Recalls
No recall linked to Ofev 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.