FDA Orange Book
Generic for Diamox
Diamox contains acetazolamide. 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 Diamox is acetazolamide. 26 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
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Diamox products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, extended release, oral | 500MG | Discontinued | None | 8 | AB |
| injectable, injection | EQ 500MG BASE/VIAL | Discontinued | None | 6 | AP |
| tablet, oral | 125MG | Discontinued | None | 12 | AB |
| tablet, oral | 250MG | Discontinued | None | 13 | AB |
NDA 012945, 009388, 008943, held by TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic acetazolamide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 040089 | AP (A-rated, therapeutically equivalent) | February 28, 1995 | EQ 500MG BASE/VIAL |
| TARO PHARMACEUTICAL INDUSTRIES LTD | 040195 | AB (A-rated, therapeutically equivalent) | May 28, 1997 | 125MG, 250MG |
| HERITAGE PHARMA LABS INC | 040904 | AB (A-rated, therapeutically equivalent) | December 10, 2008 | 500MG |
| XGEN PHARMACEUTICALS DJB INC | 040784 | AP (A-rated, therapeutically equivalent) | December 10, 2008 | EQ 500MG BASE/VIAL |
| INDICUS PHARMA LLC | 090779 | AB (A-rated, therapeutically equivalent) | July 14, 2011 | 500MG |
| MYLAN ASI LLC | 200880 | AP (A-rated, therapeutically equivalent) | May 9, 2012 | EQ 500MG BASE/VIAL |
| AVET LIFESCIENCES LTD | 202693 | AP (A-rated, therapeutically equivalent) | December 19, 2014 | EQ 500MG BASE/VIAL |
| MPP PHARMA LLC | 204691 | AB (A-rated, therapeutically equivalent) | March 29, 2016 | 500MG |
| NOVAST LABORATORIES LTD | 203434 | AB (A-rated, therapeutically equivalent) | September 30, 2016 | 500MG |
| HERITAGE PHARMA LABS INC | 205530 | AB (A-rated, therapeutically equivalent) | October 27, 2016 | 125MG, 250MG |
| STRIDES PHARMA GLOBAL PTE LTD | 209734 | AB (A-rated, therapeutically equivalent) | November 20, 2017 | 125MG, 250MG |
| ACCORD HEALTHCARE INC | 207659 | AB (A-rated, therapeutically equivalent) | October 18, 2018 | 500MG |
| CADILA HEALTHCARE LTD | 205301 | AB (A-rated, therapeutically equivalent) | January 16, 2019 | 500MG |
| ALEMBIC PHARMACEUTICALS LTD | 210423 | AB (A-rated, therapeutically equivalent) | February 19, 2019 | 500MG |
| ZYDUS PHARMACEUTICALS USA INC | 206533 | AP (A-rated, therapeutically equivalent) | April 15, 2019 | EQ 500MG BASE/VIAL |
| NOVITIUM PHARMA LLC | 210588 | AB (A-rated, therapeutically equivalent) | October 17, 2019 | 125MG, 250MG |
| ADAPTIS PHARMA PRIVATE LTD | 211556 | AB (A-rated, therapeutically equivalent) | October 18, 2019 | 125MG, 250MG |
| MICRO LABS LTD INDIA | 207401 | AB (A-rated, therapeutically equivalent) | October 1, 2020 | 500MG |
| MANKIND PHARMA LTD | 214282 | AB (A-rated, therapeutically equivalent) | October 7, 2020 | 125MG, 250MG |
| SOMERSET THERAPEUTICS LLC | 211372 | AB (A-rated, therapeutically equivalent) | February 22, 2021 | 125MG, 250MG |
| RUBICON RESEARCH LTD | 215101 | AB (A-rated, therapeutically equivalent) | August 19, 2021 | 125MG, 250MG |
| ZYDUS LIFESCIENCES GLOBAL FZE | 211069 | AB (A-rated, therapeutically equivalent) | April 4, 2023 | 125MG, 250MG |
| NE RX PHARMA LLC | 217197 | AB (A-rated, therapeutically equivalent) | May 9, 2023 | 125MG, 250MG |
| EPIC PHARMA LLC | 218023 | AB (A-rated, therapeutically equivalent) | May 14, 2024 | 125MG, 250MG |
| AUROBINDO PHARMA LTD | 212089 | AB (A-rated, therapeutically equivalent) | May 30, 2025 | 125MG, 250MG |
| GLAND PHARMA LTD | 219775 | AP (A-rated, therapeutically equivalent) | June 17, 2025 | EQ 500MG BASE/VIAL |
| CHARTWELL MOLECULAR HOLDINGS LLC | 084840 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 250MG |
Questions
Is there a generic for Diamox?
Yes. The generic name for Diamox is acetazolamide. 26 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
What is the generic name for Diamox?
The active ingredient in Diamox is acetazolamide, 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.