FDA Orange Book
Generic for Betagan
Betagan contains levobunolol. 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 Betagan is levobunolol. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT. Generics match 1 of the 2 Betagan products the Orange Book lists.
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Betagan products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution/drops, ophthalmic | 0.25% | Discontinued | None | 0 | None |
| solution/drops, ophthalmic | 0.5% | Marketed (Rx) | AT | 1 | AT |
NDA 019814, 019219, held by ALLERGAN PHARMACEUTICAL. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic levobunolol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| BAUSCH AND LOMB INC | 074326 | AT (A-rated, therapeutically equivalent) | March 4, 1994 | 0.5% |
Questions
Is there a generic for Betagan?
Yes. The generic name for Betagan is levobunolol. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT. Generics match 1 of the 2 Betagan products the Orange Book lists.
What is the generic name for Betagan?
The active ingredient in Betagan is levobunolol, 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.