Skip to content
LookupMeds

Active ingredient

Acetazolamide

73 finished FDA listings contain Acetazolamide as their only active ingredient.

See all listingsCompare with another medication

FDA NDC Directory

Ingredient names as written by FDA
ACETAZOLAMIDE, ACETAZOLAMIDE SODIUM
Dosage forms
Capsule, Capsule, Extended Release, Injection, Powder, For Solution, Injection, Powder, Lyophilized, For Solution, Tablet
Routes
Intravenous, Oral
Manufacturers / labelers
38
Strengths listed
125 mg/1 · 250 mg/1 · 500 mg/1 · 500 mg/5ml
Brand names in FDA listings
Acetazolamide

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 167

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
ANDA 040089HIKMA1995-02-282
ANDA 040784XGEN PHARMS2008-12-101
ANDA 040904HERITAGE PHARMA2008-12-104
ANDA 090779INDICUS PHARMA2011-07-141
ANDA 200880MYLAN ASI2012-05-091
ANDA 202693AVET LIFESCIENCES2014-12-192
ANDA 203434NOVAST LABS2016-09-301
ANDA 205530HERITAGE PHARMA2016-10-279
ANDA 209734STRIDES PHARMA2017-11-207
ANDA 207659ACCORD HLTHCARE2018-10-182
ANDA 205301CADILA2019-01-163
ANDA 210423ALEMBIC2019-02-192
ANDA 210588NOVITIUM PHARMA2019-10-172
ANDA 211556ADAPTIS2019-10-184
ANDA 207401MICRO LABS LTD INDIA2020-10-012
ANDA 214282MANKIND PHARMA2020-10-076
ANDA 211372SOMERSET THERAPS LLC2021-02-222
ANDA 215101RUBICON RESEARCH2021-08-194
ANDA 211069ZYDUS LIFESCIENCES2023-04-048
ANDA 217197NE RX PHARMA2023-05-094
ANDA 211151AJANTA PHARMA LTD2023-09-112
ANDA 212089AUROBINDO PHARMA LTD2025-05-302
ANDA 219775GLAND2025-06-172

Official labeling on DailyMed

Showing the 12 most recent of 55 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.