Quick answers
- What is Flucytosine used for?
- The FDA-approved label (Ancobon, Bausch Health US LLC, February 2, 2022) says: “ANCOBON is indicated only in the treatment of serious infections caused by susceptible strains of Candida and/or Cryptococcus. Candida: Septicemia, endocarditis and urinary system infections have been effectively treated with flucytosine. Limited trials in pulmonary infections justify the use of flucytosine. Cryptococcus: Meningitis and pulmonary infections have been treated effectively. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Flucytosine have a boxed warning?
- Yes. The FDA label for Ancobon has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Flucytosine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Flucytosine been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Flucytosine?
- 10 companies list prescription products of Flucytosine in the FDA NDC Directory, including Major Pharmaceuticals, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. and Novel Laboratories, Inc..
What Flucytosine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ANCOBON is indicated only in the treatment of serious infections caused by susceptible strains of Candida and/or Cryptococcus. Candida: Septicemia, endocarditis and urinary system infections have been effectively treated with flucytosine. Limited trials in pulmonary infections justify the use of flucytosine. Cryptococcus: Meningitis and pulmonary infections have been treated effectively. …
— FDA label: Ancobon, Bausch Health US LLC, effective February 2, 2022. Read the full label on DailyMed →
The FDA has 10 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
10 of 10 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule |
|---|---|
| Route | Oral |
| Prescription products | 20 in the FDA NDC Directory |
| Brand names | Ancobon |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Major Pharmaceuticals2 products
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.2 products
- Novel Laboratories, Inc.2 products
- Bausch Health US, LLC2 products
- Sigmapharm Laboratories, LLC2 products
- Lupin Pharmaceuticals, Inc.2 products
- Aurobindo Pharma Limited2 products
- AvPAK2 products
- Laurus Labs Limited2 products
- American Health Packaging2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA017001 ANCOBON | Bausch | November 26, 1971 | 24, latest February 15, 2022 2022: Labeling · 2019: Labeling · 2017: Labeling |
Generic approvals (5)
- ANDA201566Sigmapharm Labs LLC · June 28, 2011
- ANDA204652Novel Labs Inc · July 7, 2017
- ANDA212632Strides Pharma · April 17, 2020
- ANDA213665Aurobindo Pharma Ltd · May 1, 2020
- ANDA218005Pharmobedient · July 23, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 197702, 197703, 207125, 207127 |
|---|---|
| SPL set ID of the quoted label | aea0df00-a88c-4a16-abcf-750f3ff2004e |
| FDA labels (SPL) | 10 |
| FDA applications | NDA017001, 5 ANDA |
| Active ingredients (FDA) | FLUCYTOSINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Ancobon, Bausch Health US LLC, effective February 2, 2022; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- 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 recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →