FDA Orange Book
Generic for Neptazane
Neptazane contains methazolamide. 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 Neptazane is methazolamide. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Neptazane products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 25MG | Discontinued | None | 6 | AB |
| tablet, oral | 50MG | Discontinued | None | 6 | AB |
NDA 011721, held by LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic methazolamide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ANI PHARMACEUTICALS INC | 040001 | AB (A-rated, therapeutically equivalent) | June 30, 1993 | 25MG, 50MG |
| CHARTWELL RX SCIENCES LLC | 040036 | AB (A-rated, therapeutically equivalent) | June 30, 1993 | 25MG, 50MG |
| PHARMOBEDIENT CONSULTING LLC | 040062 | AB (A-rated, therapeutically equivalent) | January 27, 1994 | 25MG, 50MG |
| BAUSCH AND LOMB INC | 207438 | AB (A-rated, therapeutically equivalent) | October 5, 2018 | 25MG, 50MG |
| TAGI PHARMA INC | 215615 | AB (A-rated, therapeutically equivalent) | October 18, 2022 | 25MG, 50MG |
| AJANTA PHARMA LTD | 217408 | AB (A-rated, therapeutically equivalent) | February 9, 2026 | 25MG, 50MG |
Questions
Is there a generic for Neptazane?
Yes. The generic name for Neptazane is methazolamide. 6 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 Neptazane?
The active ingredient in Neptazane is methazolamide, 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.