FDA Orange Book

Generic for Betimol

Betimol contains timolol. 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 Betimol is timolol. 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 Betimol products the Orange Book lists.

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Betimol products in the Orange Book

Betimol products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
solution/drops, ophthalmic0.25%DiscontinuedNone0None
solution/drops, ophthalmic0.5%Marketed (Rx)AT1AT

NDA 020439, held by THEA PHARMA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic timolol

Approved generic versions of Betimol
CompanyANDATE codeApprovedStrengths
SOMERSET THERAPEUTICS LLC216654AT (A-rated, therapeutically equivalent)October 10, 20240.5%

Betimol NDC codes

Questions

Is there a generic for Betimol?

Yes. The generic name for Betimol is timolol. 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 Betimol products the Orange Book lists.

What is the generic name for Betimol?

The active ingredient in Betimol is timolol, 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.

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