Quick answers
- What is Ketoconazole used for?
- The FDA-approved label (Ketodan, Medimetriks Pharmaceuticals, Inc., December 5, 2024) says: “1. INDICATIONS AND USAGE Ketodan ® Foam, 2% is indicated for the topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older. Ketodan ® Foam, 2% is indicated for topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older. Limitations of Use Safety and efficacy of Ketodan ® Foam, 2% for treatment of fungal infections have not been established. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ketoconazole have a boxed warning?
- The label we quote has no boxed warning, but 12 of 56 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Ketoconazole?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Ketoconazole been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started April 13, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Ketoconazole?
- 28 companies list prescription products of Ketoconazole in the FDA NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions and NuCare Pharmaceuticals, Inc..
What Ketoconazole is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
1. INDICATIONS AND USAGE Ketodan ® Foam, 2% is indicated for the topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older. Ketodan ® Foam, 2% is indicated for topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older. Limitations of Use Safety and efficacy of Ketodan ® Foam, 2% for treatment of fungal infections have not been established. …
— FDA label: Ketodan, Medimetriks Pharmaceuticals, Inc., effective December 5, 2024. Read the full label on DailyMed →
The FDA has 56 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.
12 of 56 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Cream · Shampoo, suspension · Tablet · Aerosol, foam · Shampoo |
|---|---|
| Route | Topical · Oral |
| Prescription products | 57 in the FDA NDC Directory |
| Brand names | Ketodan |
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 |
|---|---|---|
| ketoconazole 2% aerosol, foam | Generic | $3.55–$5.62 per gram 5 packages, lowest to highest |
| ketoconazole 2% cream | Generic | $0.1616–$0.2706 per gram 15 packages, lowest to highest |
| ketoconazole 20 mg/mL shampoo | Generic | $0.0759 per mL |
| ketoconazole 20 mg/mL shampoo, suspension | Generic | $0.0759 per mL |
| ketoconazole 200 mg tablet | Generic | $0.6791 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.
- Bryant Ranch Prepack12 products
- A-S Medication Solutions6 products
- NuCare Pharmaceuticals, Inc.4 products
- Direct_Rx3 products
- Proficient Rx LP3 products
- Preferred Pharmaceuticals Inc.3 products
- Sun Pharmaceutical Industries, Inc.2 products
- Golden State Medical Supply, Inc.2 products
- NorthStar Rx LLC2 products
- Padagis Israel Pharmaceuticals Ltd2 products
- Viona Pharmaceuticals Inc1 product
- E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC1 product
- Remedyrepack Inc.1 product
- Amerisyn LLC1 product
- Strides Pharma Science Limited1 product
- Xiromed, LLC1 product
- IPG Pharmaceuticals, Inc.1 product
- Cosette Pharmaceuticals, Inc.1 product
- Teva Pharmaceuticals USA, Inc.1 product
- Asclemed USA, Inc.1 product
- Encube Ethicals, Inc.1 product
- Burel Pharmaceuticals, LLC1 product
- Medimetriks Pharmaceuticals, Inc.1 product
- Zydus Lifesciences Limited1 product
- PD-Rx Pharmaceuticals, Inc.1 product
- Amici Pharma, Inc.1 product
- Sportpharm LLC1 product
- ANI Pharmaceuticals, Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (13)
- ANDA075319Taro · June 15, 1999
- ANDA075581Teva · April 25, 2000
- ANDA075912Pharmazone · January 10, 2002
- ANDA075638Sun Pharma Canada · December 18, 2002
- ANDA076419Padagis Israel · January 7, 2004
- ANDA076294Fougera Pharms · April 28, 2004
- ANDA076942Cosette Pharms Nc · April 11, 2005
- ANDA091550Padagis Israel · August 25, 2011
- ANDA210457Strides Pharma · June 18, 2018
- ANDA212443Encube · May 20, 2021
- ANDA213601Xiromed · May 21, 2021
- ANDA218498Novitium Pharma · September 16, 2024
- ANDA218559Zydus Lifesciences · March 7, 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.
-
April 13, 2022 · Class II · Terminated · D-1065-2022
cGMP deviations: Temperature abuse
Ketoconazole Cream, 2%, Net Wt 60 grams tube, Rx only, MFG: Nycomed Inc, NDC 0168-0099-60 — Mckesson Medical-Surgical Inc. Corporate Office
-
November 18, 2013 · Class III · Terminated · D-1044-2014
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0099-30, UPC 3 0168-0099-30 9. — Fougera Pharmaceuticals Inc.
-
July 18, 2012 · Class III · Terminated · D-241-2013
Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary drug recall by Fougera due to an Out Of Specification result for an unknown degradant product
Fougera Ketoconazole Cream 2%, 15g tube, Rx only, Labeled with E. Fougera & Co., a division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0099-15 — Fougera 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) — Ketodan, Medimetriks Pharmaceuticals, Inc., effective December 5, 2024; 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 →