FDA Orange Book
Generic for Myambutol
Myambutol contains ethambutol. 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 Myambutol is ethambutol. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 4 Myambutol products the Orange Book lists.
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Myambutol products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG | Marketed (Rx) | AB | 2 | AB |
| tablet, oral | 200MG | Discontinued | None | 0 | None |
| tablet, oral | 400MG | Marketed (Rx) | AB | 2 | AB |
| tablet, oral | 500MG | Discontinued | None | 0 | None |
NDA 016320, held by KANCHAN HEALTHCARE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ethambutol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| EPIC PHARMA LLC | 075095 | AB (A-rated, therapeutically equivalent) | November 30, 1999 | 100MG, 400MG |
| LUPIN LTD | 078939 | AB (A-rated, therapeutically equivalent) | June 17, 2009 | 100MG, 400MG |
Myambutol NDC codes
Questions
Is there a generic for Myambutol?
Yes. The generic name for Myambutol is ethambutol. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 4 Myambutol products the Orange Book lists.
What is the generic name for Myambutol?
The active ingredient in Myambutol is ethambutol, 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.