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MedsAcross

Medicine

Acetazolamide 500 mg/5 mL powder for injection

Acetazolamide · Intravenous
Available on requestPrescription onlyUS FDAGeneric name

Acetazolamide 500 mg/5 mL powder for injection is a generic prescription medicine for intravenous use, made by 5 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.

Availability

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Store at 20° to 25°C (68° to 77°F) excursions permitted between 15° to 30°C…

Key facts

Active ingredient (INN)
Acetazolamide
Brand
Sold under the generic name
Strength
500 mg/5 mL
Dosage form
Powder for injection
Route
Intravenous
Packs
5 mL, 1 vial and 4 more
Manufacturers
Avet PharmaceuticalsIndiaGland PharmaIndiaMylan InstitutionalSagent PharmaceuticalsXGen Pharmaceuticals DJB
Origin register
US FDA, United States
Storage
Store at 20° to 25°C (68° to 77°F) excursions permitted between 15° to 30°C (59° to 86°F). Reconstituted solution should be stored in refrigerator at 2° to 8°C (36° to 46°F).
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
S01EC01 Acetazolamide
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
10 December 2008
Identifiers
RxCUI 307702DailyMed set ID 60f656ff-97b1-4a89-99af-8100483c2bac, 4dd56001-4941-4ff0-9f30-02a1bcc4fe7e, a9199d3c-ce52-4db5-aa36-408f4e15e344 +4NDC 23155-313, 23155-831, 39822-0190 +4Application ANDA202693, ANDA040784, ANDA219775 +1

Record updated 12 November 2026

Documents available

Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.

No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.

Packs

Packs from every labeler of this generic presentation.

PackCodeLabelerMarketed since
5 mL in 1 vial, glass23155-313-31Avet PharmaceuticalsIndia6 October 2021
1 vial, glass in 1 carton / 5 mL in 1 vial, glass23155-831-31Avet PharmaceuticalsIndia15 November 2022
1 vial in 1 carton / 5 mL in 1 vial68083-661-01Gland PharmaIndia17 June 2025
1 vial in 1 carton / 5 mL in 1 vial67457-853-50Mylan Institutional13 September 2018
1 vial in 1 carton / 5 mL in 1 vial72078-092-50Mylan Institutional1 September 2026
1 vial in 1 carton / 5 mL in 1 vial25021-839-20Sagent Pharmaceuticals15 January 2026
1 vial, glass in 1 carton / 5 mL in 1 vial, glass39822-0190-1XGen Pharmaceuticals DJB1 March 2009

Status by register

Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 27 July 1953Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Import route

Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.

Import guides are available for 25 countries. Pick one to see its route summary.

BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides

Other strengths and forms of Acetazolamide

Clinical summary

Acetazolamide is a carbonic anhydrase inhibitor indicated for the prevention or amelioration of symptoms associated with acute mountain sickness in climbers attempting rapid ascent and in those, among other approved uses. MedsAcross supplies Acetazolamide for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Read about Acetazolamide

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Acetazolamide 500 mg/5 mL powder for injection for your hospital or patient?

Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.