FDA Orange Book
Generic for Ancobon
Ancobon contains flucytosine. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Ancobon is flucytosine. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Ancobon products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 250MG | Marketed (Rx) | AB | 5 | AB |
| capsule, oral | 500MG | Marketed (Rx) | AB | 5 | AB |
NDA 017001, held by BAUSCH HEALTH US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic flucytosine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SIGMAPHARM LABORATORIES LLC | 201566 | AB (A-rated, therapeutically equivalent) | June 28, 2011 | 250MG, 500MG |
| NOVEL LABORATORIES INC | 204652 | AB (A-rated, therapeutically equivalent) | July 7, 2017 | 250MG, 500MG |
| STRIDES PHARMA GLOBAL PTE LTD | 212632 | AB (A-rated, therapeutically equivalent) | April 17, 2020 | 250MG, 500MG |
| AUROBINDO PHARMA LTD | 213665 | AB (A-rated, therapeutically equivalent) | May 1, 2020 | 250MG, 500MG |
| PHARMOBEDIENT CONSULTING LLC | 218005 | AB (A-rated, therapeutically equivalent) | July 23, 2025 | 250MG, 500MG |
Ancobon NDC codes
Questions
Is there a generic for Ancobon?
Yes. The generic name for Ancobon is flucytosine. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Ancobon?
The active ingredient in Ancobon is flucytosine, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.