Quick answers
- What is Itraconazole used for?
- The FDA-approved label (Sporanox, Janssen Pharmaceuticals, Inc., July 13, 2026) says: “SPORANOX ® (itraconazole) Capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: Blastomycosis, pulmonary and extrapulmonary Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Itraconazole have a boxed warning?
- Yes. The FDA label for Sporanox has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Itraconazole?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated February 27, 2026). Ask your pharmacist about alternatives.
- Has Itraconazole been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Itraconazole?
- 14 companies list prescription products of Itraconazole in the FDA NDC Directory, including Amneal Pharmaceuticals LLC, Alembic Pharmaceuticals Limited and Mayne Pharma Commercial LLC.
What Itraconazole is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
SPORANOX ® (itraconazole) Capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: Blastomycosis, pulmonary and extrapulmonary Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to …
— FDA label: Sporanox, Janssen Pharmaceuticals, Inc., effective July 13, 2026. Read the full label on DailyMed →
The FDA has 13 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.
This label has a boxed warning. Read it on the full label →
13 of 13 FDA labels for this medicine have a boxed warning.
Forms and how it is given
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 |
|---|---|---|
| itraconazole 10 mg/mL solution | Generic | $1.10 per mL |
| itraconazole 100 mg capsule | Generic | $0.8487 per capsule |
| itraconazole 100 mg capsule | Brand: Sporanox | $28.36 per capsule |
| itraconazole 100 mg capsule, coated pellets | Generic | $0.8487 per capsule |
NADAC list of November 4, 2026; these prices took effect between January 2, 2026 and 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.
- Amneal Pharmaceuticals LLC2 products
- Alembic Pharmaceuticals Limited1 product
- Mayne Pharma Commercial LLC1 product
- American Health Packaging1 product
- Ascend Laboratories, LLC1 product
- Camber Pharmaceuticals, Inc.1 product
- Patriot Pharmaceuticals1 product
- Janssen Pharmaceuticals, Inc.1 product
- Natco Pharma USA LLC1 product
- Torrent Pharmaceuticals Limited1 product
- NorthStar RxLLC1 product
- Alembic Pharmaceuticals Inc.1 product
- Rising Pharma Holdings, Inc.1 product
- AvPAK1 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 |
|---|---|---|---|
| NDA020083 SPORANOX | Janssen Pharms | September 11, 1992 | 52, latest July 7, 2026 2026: Labeling · 2024: Labeling · 2024: Labeling |
| NDA208901 TOLSURA | Mayne Pharma | December 11, 2018 | 1, latest October 25, 2024 2024: Labeling |
Generic approvals (7)
- ANDA205573Amneal Pharms · October 30, 2015
- ANDA205080Amneal Pharms · September 26, 2016
- ANDA205724Rising · December 13, 2016
- ANDA206741Alembic · December 13, 2016
- ANDA208591Alkem Labs Ltd · June 12, 2017
- ANDA209460Torrent · August 24, 2018
- ANDA212239Annora Pharma · September 1, 2020
Shortage status
To be discontinued · updated February 27, 2026 · first posted February 27, 2026
| Product | Sporanox, Capsule, 100 mg (NDC 50458-290-01) |
|---|---|
| Company | Janssen Pharmaceuticals |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Sporanox, Janssen Pharmaceuticals, Inc., effective July 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 →