FDA Orange Book
Generic for Mycobutin
Mycobutin contains rifabutin. 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 Mycobutin is rifabutin. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Mycobutin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 150MG | Marketed (Rx) | AB | 3 | AB |
NDA 050689, held by PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic rifabutin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| NOVITIUM PHARMA LLC | 215041 | AB (A-rated, therapeutically equivalent) | December 17, 2021 | 150MG |
| PHARMAZONE | 212430 | AB (A-rated, therapeutically equivalent) | March 19, 2026 | 150MG |
| ZYDUS LIFESCIENCES LTD | 219519 | AB (A-rated, therapeutically equivalent) | August 21, 2026 | 150MG |
Mycobutin NDC codes
Questions
Is there a generic for Mycobutin?
Yes. The generic name for Mycobutin is rifabutin. 3 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 Mycobutin?
The active ingredient in Mycobutin is rifabutin, 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.