FDA Orange Book
Generic for Azopt
Azopt contains brinzolamide. 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 Azopt is brinzolamide. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Azopt products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension/drops, ophthalmic | 1% | Marketed (Rx) | AB | 2 | AB |
NDA 020816, held by SANDOZ INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic brinzolamide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| WATSON LABORATORIES INC | 209406 | AB (A-rated, therapeutically equivalent) | November 27, 2020 | 1% |
| BAUSCH AND LOMB INC | 204884 | AB (A-rated, therapeutically equivalent) | August 18, 2021 | 1% |
Azopt NDC codes
Questions
Is there a generic for Azopt?
Yes. The generic name for Azopt is brinzolamide. 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 Azopt?
The active ingredient in Azopt is brinzolamide, 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.