Zyflo is a brand name of Zileuton, a prescription medicine. The FDA NDC Directory lists 1 Zyflo product in 1 strength and form.

Chiesi holds the FDA application for Zyflo (NDA020471, approved December 9, 1996).

Is there a generic or store brand of Zyflo?

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

Zyflo (Zileuton): 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 Zyflo?: Zyflo is a brand name of Zileuton, a prescription medicine. The FDA NDC Directory lists 1 Zyflo product in 1 strength and form.
Who makes Zyflo?: Chiesi holds the FDA application for Zyflo (NDA020471, approved December 9, 1996).
Is there a generic or store brand of Zyflo?: Other products of Zileuton are listed with the FDA, but none in exactly the same strength and form as a Zyflo product.
Has Zyflo been recalled?: No recall linked to Zyflo products (by their NDC code or label) appears in the FDA enforcement reports we use.

What Zyflo is

Each Zyflo 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.

Zileuton · prescription medicine

Strength and form	Product names	Same medicine, other names	Label
zileuton 600 mg tablet (oral)	Zyflo	None listed	DailyMed

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

FDA approval

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

FDA applications of Zyflo products (Drugs@FDA)
Application	Holder	First approved	Products
NDA020471	Chiesi	December 9, 1996	1

Companies that list Zyflo

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

Chiesi USA, Inc.1 product

Recalls

No recall linked to Zyflo 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.

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Zyflo