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Medicine

Posaconazole 100 mg delayed-release tablet

Posaconazole · Oral
Available on requestPrescription onlyUS FDAGeneric name

Posaconazole 100 mg delayed-release tablet is a generic prescription medicine for oral use, made by 18 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)
Posaconazole
Brand
Sold under the generic name
Strength
100 mg
Dosage form
Delayed-release tablet
Route
Oral
Packs
60 tablets, 30 tablets, 24 tablets and 24 more
Manufacturers
Aurobindo PharmaIndiaBioconIndiaCamber PharmaceuticalsIndiaDr. Reddy's LaboratoriesIndiaLupinIndiaBryant Ranch PrepackLannettAmerican Health PackagingAmneal Pharmaceuticals NYAtlantic Biologicals
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
J02AC04 Posaconazole
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
28 August 2019
Identifiers
RxCUI 1482908DailyMed set ID d8d8dd03-46b5-bd26-bb27-7ca31d8c3326, d2daba09-f1c2-4764-a567-1291be4892b9, 94a9b028-a2bc-4f41-884d-2d6c536881fc +17NDC 43598-470, 72162-2243, 0527-2133 +17Application ANDA212500, ANDA216488, ANDA212411 +6

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
60 tablet, delayed release in 1 bottle59651-596-60Aurobindo PharmaIndia18 July 2024
60 tablet, delayed release in 1 bottle70377-038-11BioconIndia8 March 2022
60 tablet, delayed release in 1 bottle31722-677-60Camber PharmaceuticalsIndia8 December 2022
60 tablet, delayed release in 1 bottle43598-470-60Dr. Reddy's LaboratoriesIndia7 April 2022
60 tablet, delayed release in 1 bottle70748-258-07LupinIndia17 February 2021
60 tablet, delayed release in 1 bottle73141-023-02A2A Integrated Pharmaceuticals16 May 2024
30 tablet, delayed release in 1 bottle69238-1476-3Amneal Pharmaceuticals NY30 December 2022
60 tablet, delayed release in 1 bottle69238-1476-6Amneal Pharmaceuticals NY30 December 2022
60 tablet, delayed release in 1 bottle72319-023-02i3 Pharmaceuticals15 September 2023
24 tablet, delayed release in 1 carton0527-2133-30Lannett31 January 2021
60 tablet, delayed release in 1 bottle0527-2133-35Lannett28 August 2019
1000 tablet, delayed release in 1 bottle0527-2133-43Lannett28 August 2019
60 tablet, delayed release in 1 bottle0406-7711-60SpecGx10 May 2022
60 tablet, delayed release in 1 bottle71335-2665-1Bryant Ranch Prepack26 June 2025
60 tablet, delayed release in 1 bottle71335-2930-1Bryant Ranch Prepack11 November 2025
20 tablet, delayed release in 1 bottle72162-2243-2Bryant Ranch Prepack19 January 2024
60 tablet, delayed release in 1 bottle72162-2243-6Bryant Ranch Prepack19 January 2024
30 blister pack in 1 box, unit-dose / 1 tablet, delayed release in 1 blister pack60687-523-21American Health Packaging11 June 2020
20 blister pack in 1 box, unit-dose / 1 tablet, delayed release in 1 blister pack60687-523-94American Health Packaging3 March 2022
100 pouch in 1 box, unit-dose / 1 tablet, delayed release in 1 pouch17856-2133-1Atlantic Biologicals9 May 2024
59 pouch in 1 box / 1 tablet, delayed release in 1 pouch17856-2133-5Atlantic Biologicals20 April 2026
60 tablet, delayed release in 1 bottle42291-919-60AvKARE20 April 2023
20 blister pack in 1 box / 1 tablet, delayed release in 1 blister pack50268-683-12AvPAK9 May 2022
60 tablet, delayed release in 1 bottle51407-676-60Golden State Medical Supply12 September 2022
30 blister pack in 1 carton / 1 tablet, delayed release in 1 blister pack0904-7149-04Major Pharmaceuticals3 February 2021
20 blister pack in 1 carton / 1 tablet, delayed release in 1 blister pack0904-7149-10Major Pharmaceuticals3 February 2021
60 tablet, delayed release in 1 bottle16714-535-01NorthStar RxLLC2 April 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

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 100 mg delayed-release 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.