FDA label
What is posaconazole used for?
The FDA-approved uses of posaconazole, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for posaconazole (tablet, delayed release) lists this use: Prophylaxis of Invasive Aspergillus and Candida Infections.
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Posaconazole, tablet, delayed release
Indications and Usage, quoted from the label by SpecGx LLC (ANDA212226). Cross-references to other label sections are left out.
Prophylaxis of Invasive Aspergillus and Candida Infections
Posaconazole delayed-release tablets are indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows:
- Posaconazole delayed-release tablets: adults and pediatric patients 13 years of age and older who weigh greater than 40 kg
Additional Pediatric Use information is approved for Merck Sharp & Dohme Corp.’s NOXAFIL (posaconazole) delayed-release tablets. However, due to Merck Sharp & Dohme Corp.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Source: DailyMed label, set id 8412398b-c696-4f12-ba3a-da74dc8dadaf, version 14, effective April 23, 2026. NDC 0406-7711, one of 20 listings for this product.
Posaconazole, injection, solution
Indications and Usage, quoted from the label by Gland Pharma Limited (ANDA217553). Cross-references to other label sections are left out.
Treatment of Invasive Aspergillosis
Posaconazole injection is indicated for the treatment of invasive aspergillosis in adults and pediatric patients 2 years of age and older who weigh 10 kg or greater.
Prophylaxis of Invasive Aspergillus and Candida Infections
Posaconazole injection is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows:
- Posaconazole injection: adults and pediatric patients 2 years of age and older who weigh 10 kg or greater.
Source: DailyMed label, set id 52d9d29e-4a37-4926-aa57-8477f5447b34, version 9, effective June 9, 2026. NDC 68083-577, one of 4 listings for this product.
Posaconazole, solution
Indications and Usage, quoted from the label by Mylan Institutional LLC (ANDA211500). Cross-references to other label sections are left out.
Treatment of Invasive Aspergillosis
Posaconazole injection is indicated for the treatment of invasive aspergillosis as follows:
- Posaconazole injection: adults and pediatric patients 2 years of age and older who weigh 10 kg or greater
Prophylaxis of Invasive Aspergillus and Candida Infections
Posaconazole injection is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows:
- Posaconazole injection: adults and pediatric patients 2 years of age and older who weigh 10 kg or greater
Source: DailyMed label, set id 1ebbd88b-547b-4b49-ab73-98094a2d5a79, version 3, effective July 15, 2026. NDC 67457-665, one of 2 listings for this product.
Questions
What is posaconazole used for?
The FDA label for posaconazole (tablet, delayed release) lists this use: Prophylaxis of Invasive Aspergillus and Candida Infections.
What drug class is posaconazole?
FDA lists posaconazole in the Azole Antifungal established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.