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Brand-name prescription medicine

Gleostine

Generic name: Lomustine

FDA application holder: Azurity

Strengths and generic versions Official label

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.

At a glance

3Strengths and forms
3Same medicine, other names
1976FDA approval
0Recalls (FDA reports)

Quick answers

What is Gleostine?
Gleostine is a brand name of Lomustine, a prescription medicine. The FDA NDC Directory lists 6 Gleostine products in 3 strengths and forms.
Who makes Gleostine?
Azurity holds the FDA application for Gleostine (NDA017588, approved August 4, 1976). 1 other company (repackagers or distributors) also list Gleostine products.
Is there a generic or store brand of Gleostine?
Yes. The FDA NDC Directory lists 3 other products with the same active ingredients, strength and form as a Gleostine product. Ask your pharmacist whether one is right for you.
Has Gleostine been recalled?
No recall linked to Gleostine products (by their NDC code or label) appears in the FDA enforcement reports we use.

What Gleostine is

Each Gleostine 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.

Lomustine · prescription medicine

Strength and formProduct namesSame medicine, other namesLabel
lomustine 10 mg
capsule, gelatin coated (oral)		 Gleostine 1 product, 1 company DailyMed
lomustine 100 mg
capsule, gelatin coated (oral)		 Gleostine 1 product, 1 company DailyMed
lomustine 40 mg
capsule, gelatin coated (oral)		 Gleostine 1 product, 1 company DailyMed

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

FDA approval

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
FDA applications of Gleostine products (Drugs@FDA)
ApplicationHolderFirst approvedProducts
NDA017588AzurityAugust 4, 19766

Companies that list Gleostine

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

Recalls

No recall linked to Gleostine products (by their NDC code or label) appears in the FDA enforcement reports.

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. 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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