Prescription medicine
Posaconazole Brand names: Noxafil
Posaconazole (Noxafil) is a prescription medicine with an FDA approval on record since 2006. FDA's NDC Directory lists it from 27 generic labelers, and pharmacies paid $2.03 per posaconazole DR 100 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- A presentation discontinued
Check it at the source: the posaconazole FDA label on DailyMed (effective August 3, 2026, Aurobindo Pharma Limited); the NDA 22003 record on Drugs@FDA; every posaconazole label on DailyMed.
Highlights of the record
FDA label of August 3, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagePosaconazole is an azole antifungal indicated as follows: 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 w
Forms and strengths
- 100 mg
- 300 mg
- 18 mg/ml
- 40 mg/ml
Delayed-release tablet; injection (solution); solution; suspension; coated tablet.
On the market
- Earliest approval on file
- September 15, 2006 Noxafil, Schering; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 21 first August 21, 2019; 20 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 29 of which 27 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- February 27, 2033 Noxafil injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $2.03 per tablet Posaconazole DR 100 mg tablet
- Shortage (FDA)
- None current 1 past records
- Recalls by its makers (FDA)
- 2 since 2023 0 Class I among all firms' recalls; latest December 12, 2025
- FAERS reports
- 16,154 through July 30, 2026
What is posaconazole used for?
From the label: indications and usagePosaconazole is an azole antifungal indicated as follows: 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: ( 1.2 ) Posaconazole delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kg 1.2 Prophylaxis of Invasive Aspergillus and Candida Infections Posaconazole delayed-release […]
Conditions named in the indications of posaconazole's FDA labels, with every medicine labeled for each:
From other posaconazole labelsFungal infections: … to 40 kg Noxafil oral suspension is indicated for the treatment of oropharyngeal candidiasis (OPC), including OPC refractory (rOPC) to itraconazole and/or fluconazole in adults and pediatric patients 13 years of age and […]
FDA pharmacologic class: Azole Antifungal.
Source: FDA drug label (POSACONAZOLE), Aurobindo Pharma Limited, effective August 3, 2026 (SPL set f8a26673-261c-4e8e-b1e1-9e23aaf7f285), via openFDA; the full label on DailyMed
Is there a generic for posaconazole (Noxafil)?
The FDA approved the first generic posaconazole on August 21, 2019. 21 generic applications are approved; 20 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists posaconazole from 27 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Noxafil oral suspension; a patent listed only for Noxafil injection runs to February 27, 2033. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2006 earliest approval on file
- 2019 first generic approved
- 2033 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for posaconazole (Noxafil)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $2.03 per Posaconazole DR 100 mg tablet, down 46% from $3.77 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Posaconazole DR 100 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Posaconazole DR 100 mg tablet | Generic | $2.03 per tablet | $60.95 | -46% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is posaconazole in shortage?
No posaconazole presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 1 record is all marked to be discontinued, the latest updated December 2, 2025. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Noxafil, Injection, 18 mg/1 mL (NDC 0085-4331-01) | Merck Sharp & Dohme Corp. | To Be Discontinued | December 2, 2025 |
Every posaconazole presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has posaconazole been recalled?
The FDA's Enforcement Report lists 2 recalls naming posaconazole since 2023: 0 Class I (the most serious), 2 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| December 12, 2025 | Class II | Merck Sharp & Dohme LLC | Presence of particulate matter: potential presence of metal particulates in the product. |
| January 31, 2023 | Class II | BIOCON PHARMA INC | Failed Impurities/Degradation Specifications: High Out Of Specification degradation results. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the posaconazole label say about other medicines?
The posaconazole label names 36 other medicines in its interaction, contraindication or warning sections. The labels of 40 other medicines name posaconazole. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Alprazolam | drug interactions | Prevention or Management; Midazolam, Alprazolam, Triazolam; Closely monitor for adverse reactions associated with high plasma concentrations of benzodiazepines that are CYP3A4 substrates during concomitant use, and a benzodiazepine receptor antagonist should be available to reverse effects [see ]. |
| Atazanavir | drug interactions | Mechanism and Clinical Effect (s); Ritonavir and atazanavir are CYP3A4 substrates and posaconazole increased plasma concentrations of these drugs [see ]. |
| Atorvastatin | contraindications | Coadministration with the HMG-CoA reductase inhibitors that are primarily metabolized through CYP3A4 (e.g., atorvastatin, lovastatin, and simvastatin) is contraindicated since increased plasma concentration of these drugs can lead to rhabdomyolysis [see Drug Interactions (7.2) and Clinical Pharmacology (12.3) ]. |
| Caffeine | drug interactions | Interaction with Posaconazole Additional clinical studies demonstrated that no clinically important effects on zidovudine, lamivudine, indinavir, or caffeine were observed when administered with posaconazole 200 mg once daily; … |
| Cimetidine | drug interactions | Interaction Drug: Rifabutin, phenytoin, efavirenz, cimetidine, esomeprazole*; Interaction: Avoid coadministration unless the benefit outweighs the risks (,) |
| Cyclosporine | drug interactions | Cyclosporine At initiation of posaconazole treatment reduce the cyclosporine dosage to approximately three-fourths of the original dosage. |
| Digoxin | drug interactions | Interaction Drug: Digoxin; Interaction: Monitor digoxin plasma concentrations () |
| Dihydroergotamine | contraindications | Posaconazole delayed-release tablets may increase the plasma concentrations of ergot alkaloids (ergotamine and dihydroergotamine) which may lead to ergotism [see Drug Interactions (7.2) ]. |
| Diltiazem | drug interactions | Prevention or Management; Verapamil, Diltiazem, Nifedipine, Nicardipine, Felodipine; Monitor frequently for adverse reactions and toxicity with concomitant use of posaconazole with calcium channel blockers that are CYP3A4 substrates. Dosage reduction of the calcium channel blocker may be needed. |
| Efavirenz | drug interactions | Interaction Drug: Rifabutin, phenytoin, efavirenz, cimetidine, esomeprazole*; Interaction: Avoid coadministration unless the benefit outweighs the risks (,) |
| Ergotamine | contraindications | Posaconazole delayed-release tablets may increase the plasma concentrations of ergot alkaloids (ergotamine and dihydroergotamine) which may lead to ergotism [see Drug Interactions (7.2) ]. |
| Esomeprazole | drug interactions | Interaction Drug: Rifabutin, phenytoin, efavirenz, cimetidine, esomeprazole*; Interaction: Avoid coadministration unless the benefit outweighs the risks (,) |
| Felodipine | drug interactions | Prevention or Management; Verapamil, Diltiazem, Nifedipine, Nicardipine, Felodipine; Monitor frequently for adverse reactions and toxicity with concomitant use of posaconazole with calcium channel blockers that are CYP3A4 substrates. Dosage reduction of the calcium channel blocker may be needed. |
| Fosamprenavir | drug interactions | Interaction Drug: Fosamprenavir, metoclopramide*; Interaction: Monitor for breakthrough fungal infections () |
Every other medicine the posaconazole label names
| Medicine named | Section | What the label says |
|---|---|---|
| Glipizide | drug interactions | However, glucose concentrations decrease in some patients concomitantly administered posaconazole and glipizide. |
| Lamivudine | drug interactions | Interaction with Posaconazole Additional clinical studies demonstrated that no clinically important effects on zidovudine, lamivudine, indinavir, or caffeine were observed when administered with … |
| Loperamide | drug interactions | … with antacids, H 2 -receptor antagonists (other than cimetidine), and loperamide [see Clinical Pharmacology (12.3) ]. |
| Lovastatin | contraindications | Coadministration with the HMG-CoA reductase inhibitors that are primarily metabolized through CYP3A4 (e.g., atorvastatin, lovastatin, and simvastatin) is contraindicated since increased plasma … |
| Metoclopramide | drug interactions | Interaction Drug: Fosamprenavir, metoclopramide*; Interaction: Monitor for breakthrough fungal infections () |
| Midazolam | drug interactions | Mechanism and Clinical Effect (s); Concomitant use of posaconazole with midazolam increased midazolam plasma concentrations which could potentiate and prolong hypnotic and sedative effects [see ]. |
| Nicardipine | drug interactions | Prevention or Management; Verapamil, Diltiazem, Nifedipine, Nicardipine, Felodipine; Monitor frequently for adverse reactions and toxicity with concomitant use of posaconazole with calcium channel … |
| Nifedipine | drug interactions | Prevention or Management; Verapamil, Diltiazem, Nifedipine, Nicardipine, Felodipine; Monitor frequently for adverse reactions and toxicity with concomitant use of posaconazole with calcium channel … |
| Phenytoin | drug interactions | Interaction Drug: Rifabutin, phenytoin, efavirenz, cimetidine, esomeprazole*; Interaction: Avoid coadministration unless the benefit outweighs the risks (,) |
| Pimozide | contraindications | Sirolimus ( 4.2 , 7.2 ) CYP3A4 substrates (pimozide, quinidine): can result in QTc interval prolongation and cases of torsades de pointes (TdP) ( 4.3 , 5.2 , 7.2 ) HMG-CoA Reductase Inhibitors … |
| Quinidine | contraindications | Sirolimus ( 4.2 , 7.2 ) CYP3A4 substrates (pimozide, quinidine): can result in QTc interval prolongation and cases of torsades de pointes (TdP) ( 4.3 , 5.2 , 7.2 ) HMG-CoA Reductase Inhibitors … |
| Rifabutin | drug interactions | Interaction Drug: Rifabutin, phenytoin, efavirenz, cimetidine, esomeprazole*; Interaction: Avoid coadministration unless the benefit outweighs the risks (,) |
| Ritonavir | drug interactions | Mechanism and Clinical Effect (s); Ritonavir and atazanavir are CYP3A4 substrates and posaconazole increased plasma concentrations of these drugs [see ]. |
| Simvastatin | contraindications | Coadministration with the HMG-CoA reductase inhibitors that are primarily metabolized through CYP3A4 (e.g., atorvastatin, lovastatin, and simvastatin) is contraindicated since increased plasma … |
| Sirolimus | contraindications | Sirolimus ( 4.2 , 7.2 ) CYP3A4 substrates (pimozide, quinidine): can result in QTc interval prolongation and cases of torsades de pointes (TdP) ( 4.3 , 5.2 , 7.2 ) HMG-CoA Reductase Inhibitors … |
| Tacrolimus | drug interactions | At initiation of posaconazole treatment, reduce the tacrolimus dosage to approximately one-third of the original tacrolimus dosage. |
| Triazolam | drug interactions | Prevention or Management; Midazolam, Alprazolam, Triazolam; Closely monitor for adverse reactions associated with high plasma concentrations of benzodiazepines that are CYP3A4 substrates during … |
| Venetoclax | contraindications | … Metabolized through CYP3A4 ( 4.4 , 7.2 ) Ergot alkaloids ( 4.5 , 7.2 ) Venetoclax: |
| Verapamil | drug interactions | Prevention or Management; Verapamil, Diltiazem, Nifedipine, Nicardipine, Felodipine; Monitor frequently for adverse reactions and toxicity with concomitant use of posaconazole with calcium channel … |
| Vinblastine | drug interactions | Vinca alkaloids (e.g., vincristine, vinblastine) Reserve concomitant use for patients with no alternative antifungal treatment options [see Warnings and Precautions (5.8) ]. |
| Vincristine | drug interactions | Vinca alkaloids (e.g., vincristine, vinblastine) Reserve concomitant use for patients with no alternative antifungal treatment options [see Warnings and Precautions (5.8) ]. |
| Zidovudine | drug interactions | Interaction with Posaconazole Additional clinical studies demonstrated that no clinically important effects on zidovudine, lamivudine, indinavir, or caffeine were observed when administered with … |
Other labels that name posaconazole
Source: FDA drug label (POSACONAZOLE), Aurobindo Pharma Limited, effective August 3, 2026 (SPL set f8a26673-261c-4e8e-b1e1-9e23aaf7f285), via openFDA; the full label on DailyMed
What do FAERS reports show for posaconazole?
The FDA Adverse Event Reporting System holds 16,154 reports that list posaconazole among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3,855 are coded as a death and 7,189 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as posaconazole?
8 other medicines are given the same way (oral) and in the same FDA class as posaconazole or labeled mainly for the same use (fungal infections), the same class first. Fungal infections lists all 33 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Fluconazole | Fungal infections | 38 labelers | $0.380 per tablet 200 mg tablet | No current entry |
| Voriconazole | Fungal infections | 21 labelers | $1.88 per tablet 200 mg tablet | A presentation being discontinued |
| Itraconazole | Fungal infections | 11 labelers | $0.910 per capsule 100 mg capsule | A presentation being discontinued |
| Clotrimazole | Fungal infections | 3 labelers | $0.292 per troche 10 mg troche | No current entry |
| Terbinafine | Fungal infections | 22 labelers | $0.143 per tablet 250 mg tablet | No current entry |
| Nystatin | Fungal infections | 21 labelers | $0.0569 per mL 100,000 unit/mL suspension | No current entry |
| Griseofulvin | Fungal infections | 10 labelers | $3.74 per tablet 250 mg tablet | No current entry |
| Flucytosine | Fungal infections | 9 labelers | n/a | No current entry |
Every medicine labeled for the same conditions as posaconazole
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does posaconazole compare with medicines for the same use?
3 side-by-side pages set posaconazole beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to posaconazole
- 8 medicines for the same use
- Other azole antifungals
- the pharmacologic class, with prices and generics
- Posaconazole side effects
- the label's list beside FAERS reports
- Posaconazole shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other