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Medicine

Voriconazole 50 mg tablet

Voriconazole · Oral
Available on requestPrescription onlyUS FDAGeneric name

Voriconazole 50 mg tablet is a generic prescription medicine for oral use, made by 13 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).

Key facts

Active ingredient (INN)
Voriconazole
Brand
Sold under the generic name
Strength
50 mg
Dosage form
Tablet
Route
Oral
Packs
30 tablets, 100 tablets, 3 blister pack and 27 more
Manufacturers
Viona PharmaceuticalsIndiaZydus LifesciencesIndiaAurobindo PharmaIndiaAjanta PharmaIndiaLupinIndiaSandozSolco HealthcareAmerican Health PackagingMajor PharmaceuticalsMylan Institutional
Origin register
US FDA, United States
Storage
Store at 20° to 25°C (68° to 77°F).
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
J02AC03 Voriconazole
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
15 February 2011
Identifiers
RxCUI 349434, 349435DailyMed set ID 4fe672ff-2cef-4f88-ab85-5a4b586da20d, 49dcf3ae-6d6b-46fe-a88e-ec65f2de332e, b38165a5-d8d4-4579-a49a-fbe92e764089 +10NDC 65862-891, 0904-6596, 16714-198 +10Application ANDA206837, ANDA206747, ANDA206654 +4

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
30 tablet, film coated in 1 bottle27241-062-03Ajanta PharmaIndia31 May 2016
100 tablet, film coated in 1 bottle65862-891-01Aurobindo PharmaIndia22 January 2016
3 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack65862-891-03Aurobindo PharmaIndia22 January 2016
500 tablet, film coated in 1 bottle65862-891-05Aurobindo PharmaIndia22 January 2016
30 tablet, film coated in 1 bottle65862-891-30Aurobindo PharmaIndia22 January 2016
30 tablet, film coated in 1 bottle43386-088-03LupinIndia24 May 2016
100 tablet, film coated in 1 bottle72578-062-01Viona PharmaceuticalsIndia16 April 2019
500 tablet, film coated in 1 bottle72578-062-05Viona PharmaceuticalsIndia16 April 2019
30 tablet, film coated in 1 bottle72578-062-06Viona PharmaceuticalsIndia16 April 2019
1000 tablet, film coated in 1 bottle72578-062-10Viona PharmaceuticalsIndia16 April 2019
90 tablet, film coated in 1 bottle72578-062-16Viona PharmaceuticalsIndia16 April 2019
10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack72578-062-77Viona PharmaceuticalsIndia16 April 2019
100 tablet, film coated in 1 bottle65841-830-01Zydus LifesciencesIndia25 May 2016
500 tablet, film coated in 1 bottle65841-830-05Zydus LifesciencesIndia25 May 2016
30 tablet, film coated in 1 bottle65841-830-06Zydus LifesciencesIndia25 May 2016
1000 tablet, film coated in 1 bottle65841-830-10Zydus LifesciencesIndia25 May 2016
90 tablet, film coated in 1 bottle65841-830-16Zydus LifesciencesIndia25 May 2016
10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack65841-830-77Zydus LifesciencesIndia25 May 2016
30 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack51079-164-03Mylan Institutional8 August 2011
30 tablet, film coated in 1 bottle, plastic0378-1626-93Mylan Pharmaceuticals15 February 2011
500 tablet, film coated in 1 bottle0781-5667-05Sandoz12 December 2011
1000 tablet, film coated in 1 bottle0781-5667-10Sandoz12 December 2011
10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack0781-5667-13Sandoz12 December 2011
30 tablet, film coated in 1 bottle0781-5667-31Sandoz12 December 2011
30 tablet, coated in 1 bottle43547-377-03Solco Healthcare28 October 2016
500 tablet, coated in 1 bottle43547-377-50Solco Healthcare28 October 2016
30 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack60687-968-21American Health Packaging27 August 2026
30 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack0904-6596-04Major Pharmaceuticals25 May 2016
30 tablet, film coated in 1 bottle16714-198-01NorthStar Rx22 January 2016
30 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack48433-146-03Safecor Health6 April 2026

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 24 May 2002Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
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 Voriconazole

Clinical summary

Voriconazole is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with invasive aspergillosis, among other approved uses. MedsAcross supplies Voriconazole 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 Voriconazole

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

Data sources

Need Voriconazole 50 mg tablet 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.