FDA Orange Book
Generic for Kerlone
Kerlone contains betaxolol. 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 Kerlone is betaxolol. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Kerlone products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG | Discontinued | None | 2 | AB |
| tablet, oral | 20MG | Discontinued | None | 2 | AB |
NDA 019507, held by SANOFI AVENTIS US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic betaxolol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| EPIC PHARMA LLC | 075541 | AB (A-rated, therapeutically equivalent) | October 22, 1999 | 10MG, 20MG |
| KVK TECH INC | 078962 | AB (A-rated, therapeutically equivalent) | June 27, 2008 | 10MG, 20MG |
Questions
Is there a generic for Kerlone?
Yes. The generic name for Kerlone is betaxolol. 2 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 Kerlone?
The active ingredient in Kerlone is betaxolol, 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.