Active ingredient
Flucytosine
20 finished FDA listings contain Flucytosine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- FLUCYTOSINE
- Dosage forms
- Capsule
- Routes
- Oral
- Manufacturers / labelers
- 10
- Strengths listed
- 250 mg/1 · 500 mg/1
- Brand names in FDA listings
- Ancobon
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 4451
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 017001 | BAUSCH | 1971-11-26 | 2 |
| ANDA 201566 | SIGMAPHARM LABS LLC | 2011-06-28 | 2 |
| ANDA 204652 | NOVEL LABS INC | 2017-07-07 | 8 |
| ANDA 212632 | STRIDES PHARMA | 2020-04-17 | 2 |
| ANDA 213665 | AUROBINDO PHARMA LTD | 2020-05-01 | 4 |
| ANDA 218005 | PHARMOBEDIENT | 2025-07-23 | 2 |
Official labeling on DailyMed
- FLUCYTOSINE CAPSULE [AVPAK] · version 4 · 2026-01-14
- FLUCYTOSINE CAPSULE [MAJOR PHARMACEUTICALS] · version 7 · 2026-01-14
- FLUCYTOSINE CAPSULE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] · version 2 · 2025-11-17
- FLUCYTOSINE CAPSULE [LUPIN PHARMACEUTICALS,INC.] · version 7 · 2025-09-12
- FLUCYTOSINE CAPSULE [LAURUS LABS LIMITED] · version 1 · 2025-07-31
- FLUCYTOSINE CAPSULE [AMERICAN HEALTH PACKAGING] · version 3 · 2024-12-04
- FLUCYTOSINE CAPSULE [NOVEL LABORATORIES, INC.] · version 6 · 2023-01-23
- FLUCYTOSINE CAPSULE [SIGMAPHARM LABORATORIES, LLC] · version 4 · 2023-01-11
- ANCOBON (FLUCYTOSINE) CAPSULE [BAUSCH HEALTH US LLC] · version 16 · 2022-05-13
- FLUCYTOSINE CAPSULE [AUROBINDO PHARMA LIMITED] · version 4 · 2022-03-04
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.