Active ingredient
Lomustine
12 finished FDA listings contain Lomustine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- LOMUSTINE
- Dosage forms
- Capsule, Capsule, Gelatin Coated
- Routes
- Oral
- Manufacturers / labelers
- 4
- Strengths listed
- 10 mg/1 · 100 mg/1 · 40 mg/1
- Brand names in FDA listings
- Gleostine
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 6466
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 017588 | AZURITY | 1976-08-04 | 9 |
| ANDA 219265 | CARNEGIE | 2025-10-27 | 3 |
Official labeling on DailyMed
- LOMUSTINE CAPSULE, GELATIN COATED [WILSHIRE PHARMACEUTICALS, INC.] · version 2 · 2026-04-15
- GLEOSTINE (LOMUSTINE) CAPSULE, GELATIN COATED [AZURITY PHARMACEUTICALS, INC.] · version 1 · 2025-11-17
- LOMUSTINE CAPSULE [CARNEGIE PHARMACEUTICALS LLC] · version 1 · 2025-11-17
- GLEOSTINE (LOMUSTINE) CAPSULE, GELATIN COATED [NEXTSOURCE BIOTECHNOLOGY, LLC] · version 15 · 2024-03-05
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.