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
| 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 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
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SOMERSET THERAPEUTICS LLC | 216654 | AT (A-rated, therapeutically equivalent) | October 10, 2024 | 0.5% |
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.
More on Betimol and Timolol
- What is Betimol used for?FDA label uses
- Is Betimol a controlled substance?Federal schedule
- What is Timolol used for?FDA label uses
- Is Timolol a controlled substance?Federal schedule
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