FDA Orange Book · active-ingredient family
Acetazolamide
Acetazolamide: 2 brands, 31 generics; first approved Feb 05, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 31 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
31
Listed patents
0
Presentations
50
Brand (NDA) products
Originator applications
- DIAMOXRLDTEVA BRANDED PHARMNDA 012945—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - DIAMOXRLDTEVA BRANDED PHARMNDA 008943—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET ORAL Discontinued — 250MG TABLET ORAL Discontinued —
Generic (ANDA) products (31)
Abbreviated applications
- ACETAZOLAMIDEAUROBINDO PHARMA LTDANDA 21208920252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET ORAL Rx AB 250MG TABLET ORAL Rx AB - ACETAZOLAMIDEEPIC PHARMA LLCANDA 21802320242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET ORAL Rx AB 250MG TABLET ORAL Rx AB - ACETAZOLAMIDETORRENTANDA 21370620242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET ORAL Discontinued — 250MG TABLET ORAL Discontinued — - ACETAZOLAMIDEAJANTA PHARMA LTDANDA 21115120232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET ORAL Discontinued — 250MG TABLET ORAL Discontinued — - ACETAZOLAMIDENE RX PHARMAANDA 21719720232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET ORAL Rx AB 250MG TABLET ORAL Rx AB - ACETAZOLAMIDEZYDUS LIFESCIENCESANDA 21106920232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET ORAL Rx AB 250MG TABLET ORAL Rx AB - ACETAZOLAMIDERUBICON RESEARCHANDA 21510120212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET ORAL Rx AB 250MG TABLET ORAL Rx AB - ACETAZOLAMIDESOMERSET THERAPS LLCANDA 21137220212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET ORAL Rx AB 250MG TABLET ORAL Rx AB - ACETAZOLAMIDEMANKIND PHARMAANDA 21428220202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET ORAL Rx AB 250MG TABLET ORAL Rx AB - ACETAZOLAMIDEMICRO LABS LTD INDIAANDA 2074012020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - ACETAZOLAMIDEBRECKENRIDGEANDA 20750320202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET ORAL Discontinued — 250MG TABLET ORAL Discontinued — - ACETAZOLAMIDEHIBROW HLTHCAREANDA 21155620192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET ORAL Rx AB 250MG TABLET ORAL Rx AB - ACETAZOLAMIDENOVITIUM PHARMAANDA 21058820192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET ORAL Rx AB 250MG TABLET ORAL Rx AB - ACETAZOLAMIDERISINGANDA 2039172019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - ACETAZOLAMIDEALEMBICANDA 2104232019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - ACETAZOLAMIDERSCADILAANDA 2053012019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - ACETAZOLAMIDEACCORD HLTHCAREANDA 2076592018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - ACETAZOLAMIDESTRIDES PHARMAANDA 20973420172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET ORAL Rx AB 250MG TABLET ORAL Rx AB - ACETAZOLAMIDEHERITAGE PHARMAANDA 20553020162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET ORAL Rx AB 250MG TABLET ORAL Rx AB - ACETAZOLAMIDENOVAST LABSANDA 2034342016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - ACETAZOLAMIDEMPP PHARMAANDA 2046912016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - ACETAZOLAMIDEINDICUS PHARMAANDA 0907792011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - ACETAZOLAMIDEHERITAGE PHARMAANDA 0409042008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - ACETAZOLAMIDETAROANDA 04019519972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET ORAL Rx AB 250MG TABLET ORAL Rx AB - ACETAZOLAMIDESUN PHARM INDUSTRIESANDA 08975319882 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — 125MG TABLET ORAL Discontinued — - ACETAZOLAMIDEHERITAGE PHARMAANDA 0888821985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — - ACETAZOLAMIDEASCOTANDA 0876861982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — - ACETAZOLAMIDEVANGARDANDA 0876541982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — - ACETAZOLAMIDEALRAANDA 083320—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — - ACETAZOLAMIDECHARTWELL MOLECULARANDA 084840—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB - ACETAZOLAMIDEWATSON LABSANDA 084498—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
45 yr 2 mo ago
Most recent approval
1 yr 3 mo ago
Approvals span 1982–2025 across 33 FDA applications.
Brand (NDA) 26%
Generic (ANDA) 3194%
Acetazolamide: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
