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Medicine

Allopurinol 500 mg/25 mL powder for injection

Allopurinol · Intravenous
Available on requestPrescription onlyUS FDAGeneric name

Allopurinol 500 mg/25 mL powder for injection is a generic prescription medicine for intravenous use, made by 3 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°C to 25°C (68°F to 77°F).

Key facts

Active ingredient (INN)
Allopurinol
Brand
Sold under the generic name
Strength
500 mg/25 mL
Dosage form
Powder for injection
Route
Intravenous
Packs
1 vial
Manufacturers
Gland PharmaIndiaFresenius KabiHikma Pharmaceuticals
Origin register
US FDA, United States
Storage
Store at 20°C to 25°C (68°F to 77°F).
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
M04AA01 Allopurinol
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
1 September 2004
Identifiers
RxCUI 252931DailyMed set ID 2caf5eed-2408-4ce0-bd0d-04f4c90e434d, 4839e842-511e-4c72-9153-2b7e4e1954e2, 9ae58f3c-dbf9-4c10-9b79-233b10e0e9f1NDC 65219-380, 68083-380, 0143-9533Application ANDA212363, ANDA076870

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
1 vial, glass in 1 carton / 25 mL in 1 vial, glass68083-380-01Gland PharmaIndia26 January 2022
1 vial, glass in 1 carton / 25 mL in 1 vial, glass65219-380-30Fresenius Kabi14 March 2022
1 vial in 1 box, unit-dose / 25 mL in 1 vial0143-9533-01Hikma Pharmaceuticals1 September 2004

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 19 August 1966Drugs@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

Alternatives

Other makers and brands of Allopurinol 500 mg/25 mL powder for injection.

Compare 1

Other strengths and forms of Allopurinol

Clinical summary

Allopurinol is a xanthine oxidase inhibitor indicated for the management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) The management of adult. MedsAcross supplies Allopurinol 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 Allopurinol

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

Data sources

Need Allopurinol 500 mg/25 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.