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Medicine

Posaconazole 300.6 mg/16.7 mL injection

Posaconazole · Intravenous
Available on requestPrescription onlyUS FDA Cold chainGeneric name

Posaconazole 300.6 mg/16.7 mL injection is a generic prescription medicine for intravenous use, made by 7 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. It ships in a temperature-controlled cold chain.

Availability

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Cold chain

Storage conditions for the diluted solution are presented in another section…

Key facts

Active ingredient (INN)
Posaconazole
Brand
Sold under the generic name
Strength
300.6 mg/16.7 mL
Dosage form
Injection
Route
Intravenous
Packs
1 vial of 16.7 mL and 5 more
Manufacturers
Glenmark PharmaceuticalsIndiaCamber PharmaceuticalsIndiaEugiaIndiaGland PharmaIndiaFresensius KabiMylan InstitutionalPar Health
Origin register
US FDA, United States
Storage
Storage conditions for the diluted solution are presented in another section of the prescribing information.
Cold chain
Yes, shipped temperature controlled
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
J02AC04 Posaconazole
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
1 January 2023
Identifiers
RxCUI 1492043DailyMed set ID 2e88e379-b712-4dec-97a2-c90ef3638372, 91f89a3b-2479-4d05-9997-7b0cfaa496ec, c551e121-d5fc-4b35-ba9f-72ce3a314fdc +5NDC 55150-388, 68462-911, 31722-370 +5Application ANDA214842, ANDA217553, ANDA219057 +3

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 in 1 carton / 16.7 mL in 1 vial68462-904-01Glenmark PharmaceuticalsIndia27 December 2023
1 vial in 1 carton / 16.7 mL in 1 vial68462-911-01Glenmark PharmaceuticalsIndia1 July 2024
1 vial, glass in 1 carton / 16.7 mL in 1 vial, glass31722-370-31Camber PharmaceuticalsIndia23 December 2024
1 vial, single-dose in 1 carton / 16.7 mL in 1 vial, single-dose55150-388-01EugiaIndia26 December 2023
1 vial in 1 carton / 16.7 mL in 1 vial68083-577-01Gland PharmaIndia26 December 2023
1 vial, single-dose in 1 carton / 16.7 mL in 1 vial, single-dose63323-685-17Fresensius Kabi26 December 2023
1 vial, glass in 1 carton / 16.7 mL in 1 vial, glass67457-665-20Mylan Institutional22 March 2024
1 vial, glass in 1 carton / 16.7 mL in 1 vial, glass42023-195-01Par Health1 January 2023

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 15 September 2006Drugs@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

Alternatives

Other makers and brands of Posaconazole 300.6 mg/16.7 mL injection.

Compare 1

Other strengths and forms of Posaconazole

Clinical summary

Posaconazole is an azole antifungal indicated as follows, among other approved uses. It is available as delayed-release tablets, injection and tablets for oral and intravenous use. MedsAcross supplies Posaconazole 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 Posaconazole

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

Data sources

Need Posaconazole 300.6 mg/16.7 mL 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.