Gilotrif is a brand name of Afatinib, a prescription medicine. The FDA NDC Directory lists 3 Gilotrif products in 3 strengths and forms.

Boehringer Ingelheim holds the FDA application for Gilotrif (NDA201292, approved July 12, 2013).

Is there a generic or store brand of Gilotrif?

Other products of Afatinib are listed with the FDA, but none in exactly the same strength and form as a Gilotrif product.

Gilotrif (Afatinib): maker, FDA approval and generic versions

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 Gilotrif?: Gilotrif is a brand name of Afatinib, a prescription medicine. The FDA NDC Directory lists 3 Gilotrif products in 3 strengths and forms.
Who makes Gilotrif?: Boehringer Ingelheim holds the FDA application for Gilotrif (NDA201292, approved July 12, 2013).
Is there a generic or store brand of Gilotrif?: Other products of Afatinib are listed with the FDA, but none in exactly the same strength and form as a Gilotrif product.
Has Gilotrif been recalled?: No recall linked to Gilotrif products (by their NDC code or label) appears in the FDA enforcement reports we use.

What Gilotrif is

Each Gilotrif 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.

Afatinib · prescription medicine

Strength and form	Product names	Same medicine, other names	Label
afatinib 20 mg tablet, film coated (oral)	Gilotrif	None listed	DailyMed
afatinib 30 mg tablet, film coated (oral)	Gilotrif	None listed	DailyMed
afatinib 40 mg tablet, film coated (oral)	Gilotrif	None listed	DailyMed

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

FDA approval

NDA: New Drug Application: how a new (usually brand-name) medicine is approved.

FDA applications of Gilotrif products (Drugs@FDA)
Application	Holder	First approved	Products
NDA201292	Boehringer Ingelheim	July 12, 2013	3

Companies that list Gilotrif

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

Boehringer Ingelheim Pharmaceuticals, Inc.3 products

Recalls

No recall linked to Gilotrif 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.

Report an error → · Information for medicine makers

Gilotrif