Quick answers
- What is Voriconazole used for?
- The FDA-approved label (Vfend, Roerig, March 20, 2026) says: “VFEND is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: • Invasive aspergillosis • Candidemia in non-neutropenics and other deep tissue Candida infections • Esophageal candidiasis • Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy 1.1 …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Voriconazole have a boxed warning?
- No. None of the 43 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Voriconazole?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Voriconazole been recalled?
- FDA enforcement reports list 4 recalls of products of this medicine; the newest started March 24, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Voriconazole?
- 33 companies list prescription products of Voriconazole in the FDA NDC Directory, including Roerig, American Health Packaging and Lupin Pharmaceuticals, Inc..
What Voriconazole is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
VFEND is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: • Invasive aspergillosis • Candidemia in non-neutropenics and other deep tissue Candida infections • Esophageal candidiasis • Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy 1.1 …
— FDA label: Vfend, Roerig, effective March 20, 2026. Read the full label on DailyMed →
The FDA has 43 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 43 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Injection, powder, lyophilized, for solution · Powder, for suspension · Tablet, coated · Injection, solution · Injection · Suspension |
|---|---|
| Route | Oral · Intravenous |
| Prescription products | 57 in the FDA NDC Directory |
| Brand names | Vfend |
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 |
|---|---|---|
| voriconazole 200 mg tablet, coated | Generic | $2.05 per tablet |
| voriconazole 200 mg tablet, film coated | Generic | $2.05 per tablet |
| voriconazole 40 mg/mL powder, for suspension | Generic | $3.11 per mL |
| voriconazole 50 mg tablet, coated | Generic | $0.8334 per tablet |
| voriconazole 50 mg tablet, film coated | Generic | $0.8334 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.
- Roerig5 products
- American Health Packaging3 products
- Lupin Pharmaceuticals, Inc.3 products
- Bryant Ranch Prepack3 products
- Sandoz Inc3 products
- Mylan Pharmaceuticals Inc.3 products
- NorthStar Rx LLC2 products
- Solco Healthcare U.S., LLC2 products
- Viona Pharmaceuticals Inc2 products
- Major Pharmaceuticals2 products
- Camber Pharmaceuticals, Inc.2 products
- Mylan Institutional Inc.2 products
- Ajanta Pharma USA Inc.2 products
- Safecor Health LLC2 products
- Aurobindo Pharma Limited2 products
- Zydus Lifesciences Limited2 products
- Glenmark Pharmaceuticals Inc., USA2 products
- UBI Pharma Inc.1 product
- Hainan Poly Pharm. Co., Ltd.1 product
- Slate Run Pharmaceuticals1 product
- Meitheal Pharmaceuticals Inc.1 product
- PAI Holdings, LLC dba PAI Pharma1 product
- Civica, Inc.1 product
- Fresenius Kabi USA, LLC1 product
- Slate Run Pharmaceuticals, LLC1 product
- AvPAK1 product
- Gland Pharma Limited1 product
- Amneal Pharmaceuticals LLC1 product
- Novel Laboratories, Inc.1 product
- Xellia Pharmaceuticals USA LLC1 product
- Zhejiang Poly Pharm. Co., Ltd.1 product
- Eugia US LLC1 product
- Fosun Pharma USA Inc.1 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 |
|---|---|---|---|
| NDA021266 VFEND | Pf Prism Cv | May 24, 2002 | 42, latest February 19, 2026 2026: Labeling · 2026: Labeling · 2025: Labeling |
| NDA021267 VFEND | Pf Prism Cv | May 24, 2002 | 43, latest February 19, 2026 2026: Labeling · 2026: Labeling · 2025: Labeling |
| NDA021630 VFEND | Pf Prism Cv | December 19, 2003 | 38, latest February 19, 2026 2026: Labeling · 2026: Labeling · 2025: Labeling |
| NDA208562 VORICONAZOLE | Hikma | March 9, 2017 | 5, latest April 18, 2025 2025: Labeling · 2023: Labeling · 2022: Labeling |
Generic approvals (20)
- ANDA090547Mylan Pharms Inc · April 22, 2010
- ANDA200265Sandoz Inc · December 12, 2011
- ANDA090862Sandoz Inc · May 30, 2012
- ANDA203503Glenmark Pharms Ltd · September 2, 2015
- ANDA206837Aurobindo Pharma Ltd · January 22, 2016
- ANDA205034Amneal Pharms · April 13, 2016
- ANDA206181Ajanta Pharma Ltd · May 24, 2016
- ANDA206747Cadila · May 24, 2016
- ANDA207371Chartwell Rx · May 24, 2016
- ANDA206799Novel Labs Inc · May 31, 2016
- ANDA206654Prinston Inc · August 8, 2016
- ANDA211661Hainan Poly · November 30, 2018
- ANDA211099Gland · March 31, 2020
- ANDA214516Meitheal · May 9, 2022
- ANDA212162Eugia Pharma · February 2, 2023
- ANDA211264Ubi · March 9, 2023
- ANDA216805Zhejiang Poly Pharm · January 2, 2024
- ANDA218533Aspiro · April 3, 2024
- ANDA211598Hetero Labs Ltd V · August 8, 2025
- ANDA220043Hainan Poly Pharm · November 14, 2025
Shortage status
The FDA drug shortage list does not show these products.
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.
-
March 24, 2025 · Class II · Terminated · D-0307-2025
cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.
Voriconazole Tablets, 50 mg, packaged in cartons of 3 blister cards with 10 individual blistered doses (30 Unit Dose per carton), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 60687 — Amerisource Health Services LLC
-
March 13, 2025 · Class II · Ongoing · D-0319-2025
CGMP Deviations
Voriconazole Tablets 50mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# — Glenmark Pharmaceuticals Inc., USA
-
March 13, 2025 · Class II · Ongoing · D-0318-2025
CGMP Deviations
Voriconazole Tablets 200 mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. ND — Glenmark Pharmaceuticals Inc., USA
-
February 5, 2024 · Class II · Terminated · D-0337-2024
Labeling: Incorrect or Missing Package Insert
Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when reconstituted. Mixing Directions: Tap the bottle to release the powder. Add 50mL of water to the bottle and shake vigorously for 1 minute. Manufac — Lupin Pharmaceuticals 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) — Vfend, Roerig, effective March 20, 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 →