Acetazolamide Sodium

Sold as Diamox. Every FDA application for this active ingredient: 1 branded and 9 generic.

As of Nov 15, 2026, FDA lists 10 applications for Acetazolamide Sodium (sold as Diamox), first approved Jun 25, 1954, with 0 new uses approved and 0 published complete response letters.

First approved: Jun 25, 1954
Applications: 10
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $0K

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Acetazolamide Sodium	Part B	$0K	-100%	0

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

ACETAZOLAMIDE 125 MG TABLET: $0.096 per unitGeneric · -20% in a year
ACETAZOLAMIDE 250 MG TABLET: $0.132 per unitGeneric · -6% in a year
ACETAZOLAMIDE ER 500 MG CAP: $0.302 per unitGeneric · +14% in a year

Clinical Trials

4 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Acetazolamide in Persons With Type 1 Diabetes - Crossover TrialType 1 Diabetes · University of California, San Diego	Phase 2	Recruiting	May 20, 2025
Effect of Acetazolamide on Diuresis and Natriuresis in Patients With Acute Heart Failure (SANDI STUDY)Heart Failure, Persistent Congestion · Puerta de Hierro University Hospital	—	Recruiting	Feb 29, 2024
Investigating a Tailored Diuretic Algorithm in Acute Heart Failure PatientsHeart Failure Acute · Zuyderland Medisch Centrum	Not applicable	Recruiting	Oct 23, 2023
Treatment of Orthostatic IntoleranceTachycardia, Chronic Orthostatic Intolerance · Satish R. Raj	Phase 1 / Phase 2	Active, not recruiting	Dec 6, 2005

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Jun 25, 1954	DiamoxNDA 9388 · New dosage form	Teva Womens	10	Discontinued
Feb 28, 1995	Acetazolamide SodiumANDA 40089	Hikma	4	Marketed
Oct 30, 1995	Acetazolamide SodiumANDA 40108	Hospira	1	Discontinued
Dec 10, 2008	Acetazolamide SodiumANDA 40784	Xgen Pharms	0	Marketed
May 9, 2012	Acetazolamide SodiumANDA 200880	Mylan Asi	2	Marketed
Dec 19, 2014	Acetazolamide SodiumANDA 202693	Avet Lifesciences	3	Marketed
Jun 20, 2017	Acetazolamide SodiumANDA 205358	Ph Health	0	Discontinued
Apr 15, 2019	Acetazolamide SodiumANDA 206533	Zydus Pharms	0	Marketed
Jun 17, 2025	Acetazolamide SodiumANDA 219775	Gland	0	Marketed
—	Acetazolamide SodiumANDA 89619	Quad Pharms	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA