Quick answers
- What is Posaconazole used for?
- The FDA-approved label (Noxafil, Merck Sharp & Dohme LLC, February 13, 2026) says: “Noxafil is an azole antifungal indicated as follows: Noxafil is indicated for the treatment of invasive aspergillosis as follows: Noxafil injection: adults and pediatric patients 2 years of age and older who weigh 10 kg or greater Noxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kg Noxafil PowderMix for delayed-release oral suspension …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Posaconazole have a boxed warning?
- No. None of the 31 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Posaconazole?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated December 2, 2025). Ask your pharmacist about alternatives.
- Has Posaconazole been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started December 12, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Posaconazole?
- 29 companies list prescription products of Posaconazole in the FDA NDC Directory, including Merck Sharp & Dohme LLC, Bryant Ranch Prepack and Camber Pharmaceuticals, Inc..
What Posaconazole is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Noxafil is an azole antifungal indicated as follows: Noxafil is indicated for the treatment of invasive aspergillosis as follows: Noxafil injection: adults and pediatric patients 2 years of age and older who weigh 10 kg or greater Noxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kg Noxafil PowderMix for delayed-release oral suspension …
— FDA label: Noxafil, Merck Sharp & Dohme LLC, effective February 13, 2026. Read the full label on DailyMed →
The FDA has 31 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 31 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, delayed release · Injection, solution · Solution · Suspension · Tablet, coated · Injection · Powder, for suspension · Tablet |
|---|---|
| Route | Oral · Intravenous |
| Prescription products | 37 in the FDA NDC Directory |
| Brand names | Noxafil |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| posaconazole 100 mg tablet | Generic | $2.07 per tablet |
| posaconazole 100 mg tablet, coated | Generic | $2.07 per tablet |
| posaconazole 100 mg tablet, delayed release | Generic | $2.07 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Merck Sharp & Dohme LLC4 products
- Bryant Ranch Prepack3 products
- Camber Pharmaceuticals, Inc.2 products
- Glenmark Pharmaceuticals Inc., USA2 products
- Endo USA, Inc.2 products
- i3 Pharmaceuticals, LLC1 product
- Biocon Pharma Inc.1 product
- A2A Integrated Pharmaceuticals1 product
- American Health Packaging1 product
- Amneal Pharmaceuticals NY LLC1 product
- Lupin Pharmaceuticals, Inc.1 product
- NorthStar RxLLC1 product
- Hikma Pharmaceuticals USA Inc.1 product
- Lannett Company, Inc.1 product
- Major Pharmaceuticals1 product
- Atlantic Biologicals Corp.1 product
- AvKARE1 product
- Mylan Institutional LLC1 product
- Gland Pharma Limited1 product
- AvPAK1 product
- Eugia US LLC1 product
- Chartwell RX, LLC1 product
- Novadoz Pharmaceuticals LLC1 product
- Dr.Reddys Laboratories Inc1 product
- Golden State Medical Supply, Inc.1 product
- Aurobindo Pharma Limited1 product
- Par Health USA, LLC1 product
- Fresensius Kabi USA, LLC1 product
- SpecGx LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022003 NOXAFIL | Schering | September 15, 2006 | 24, latest January 27, 2026 2026: Efficacy · 2024: Labeling · 2022: Labeling |
| NDA205053 NOXAFIL | Merck Sharp Dohme | November 25, 2013 | 14, latest January 27, 2026 2026: Efficacy · 2024: Labeling · 2022: Labeling |
| NDA205596 NOXAFIL | Merck Sharp Dohme | March 13, 2014 | 13, latest January 27, 2026 2026: Efficacy · 2024: Labeling · 2022: Labeling |
| NDA214770 NOXAFIL POWDERMIX KIT | Msd Merck Co | May 31, 2021 | 4, latest January 27, 2026 2026: Efficacy · 2024: Labeling · 2022: Labeling |
Generic approvals (17)
- ANDA212411Sinotherapeutics Inc · August 21, 2019
- ANDA208773Hikma · May 15, 2020
- ANDA213454Aet Pharma · February 1, 2021
- ANDA214476Biocon Pharma · February 4, 2022
- ANDA212500DR Reddys · April 7, 2022
- ANDA212226Specgx LLC · May 10, 2022
- ANDA208768Ph Health · May 25, 2022
- ANDA214321Hetero Labs Ltd III · December 8, 2022
- ANDA216626Amneal · December 22, 2022
- ANDA216488Pharmazone · August 28, 2023
- ANDA209983Fresenius Kabi USA · December 26, 2023
- ANDA211500Mylan Labs Ltd · December 26, 2023
- ANDA214842Eugia Pharma · December 26, 2023
- ANDA217553Gland · December 26, 2023
- ANDA217119Aurobindo Pharma · July 18, 2024
- ANDA219057Aspiro · December 23, 2024
- ANDA218434Msn · February 24, 2025
Shortage status
To be discontinued · updated December 2, 2025 · first posted December 2, 2025
| Product | Noxafil, Injection, 18 mg/1 mL (NDC 0085-4331-01) |
|---|---|
| Company | Merck Sharp & Dohme Corp. |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
December 12, 2025 · Class II · Ongoing · D-0242-2026
Presence of particulate matter: potential presence of metal particulates in the product.
Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension, 300 mg, 8 packets per carton, Rx Only, Manufactured for: Merck Sharp & Doohme LLC, Rahway, NJ 07056 USA, Manufactured by: N.V. Organon, 5349 AB Oss, T — Merck Sharp & Dohme LLC
-
January 31, 2023 · Class II · Terminated · D-0268-2023
Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.
Posaconazole Delayed-Release Tablets, 100 mg, 60-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009; Manufactured by: Biocon Pharma Limited, Bengaluru, India - 560 099, NDC 70377-038-11. — BIOCON PHARMA INC
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Noxafil, Merck Sharp & Dohme LLC, effective February 13, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →