Quick answers
- What is Fluconazole used for?
- The FDA-approved label (Diflucan, Roerig, April 2, 2026) says: “DIFLUCAN (fluconazole) is indicated for the treatment of: 1. Vaginal candidiasis (vaginal yeast infections due to Candida ). 2. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, DIFLUCAN was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Fluconazole have a boxed warning?
- No. None of the 94 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Fluconazole?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Fluconazole been recalled?
- FDA enforcement reports list 10 recalls of products of this medicine; the newest started May 15, 2017 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Fluconazole?
- 40 companies list prescription products of Fluconazole in the FDA NDC Directory, including Bryant Ranch Prepack, Proficient Rx LP and Sportpharm LLC.
What Fluconazole is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
DIFLUCAN (fluconazole) is indicated for the treatment of: 1. Vaginal candidiasis (vaginal yeast infections due to Candida ). 2. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, DIFLUCAN was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis …
— FDA label: Diflucan, Roerig, effective April 2, 2026. Read the full label on DailyMed →
The FDA has 94 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.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
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 94 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Powder, for suspension · Injection, solution · Injection |
|---|---|
| Route | Oral · Intravenous |
| Prescription products | 163 in the FDA NDC Directory |
| Brand names | Diflucan |
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 |
|---|---|---|
| fluconazole 10 mg/mL powder, for suspension | Generic | $0.2673 per mL |
| fluconazole 100 mg tablet | Generic | $0.2188 per tablet |
| fluconazole 150 mg tablet | Generic | $0.5142 per tablet |
| fluconazole 200 mg tablet | Generic | $0.3676 per tablet |
| fluconazole 40 mg/mL powder, for suspension | Generic | $0.5468 per mL |
| fluconazole 50 mg tablet | Generic | $0.1910 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
- Proficient Rx LP10 products
- Sportpharm LLC9 products
- A-S Medication Solutions9 products
- NuCare Pharmaceuticals, Inc.8 products
- Remedyrepack Inc.8 products
- NorthStar Rx LLC6 products
- Rising Pharma Holdings, Inc.6 products
- Direct_Rx6 products
- Aurobindo Pharma Limited6 products
- Asclemed USA, Inc.6 products
- Hikma Pharmaceuticals USA Inc.5 products
- Golden State Medical Supply, Inc.4 products
- BluePoint Laboratories4 products
- Glenmark Pharmaceuticals Inc., USA4 products
- Zydus Pharmaceuticals USA Inc.4 products
- Dr. Reddy's Laboratories Limited4 products
- Chartwell RX, LLC4 products
- ANI Pharmaceuticals, Inc.4 products
- Zydus Lifesciences Limited4 products
- Radha Pharmaceuticals, Inc.4 products
- Coupler LLC4 products
- PD-Rx Pharmaceuticals, Inc.3 products
- Preferred Pharmaceuticals Inc.3 products
- Northwind Health Company, LLC3 products
- Cardinal Health 107, LLC2 products
- St. Mary's Medical Park Pharmacy2 products
- Sagent Pharmaceuticals2 products
- AvPAK2 products
- Major Pharmaceuticals2 products
- American Health Packaging2 products
- Hospira, Inc.2 products
- Mylan Pharmaceuticals Inc.2 products
- Baxter Healthcare Company2 products
- Zhejiang Poly Pharm. Co., Ltd.1 product
- Redpharm Drug1 product
- Slate Run Pharmaceuticals1 product
- Pharmasource Meds, LLC1 product
- Roerig1 product
- Hawaii Repack, 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 |
|---|---|---|---|
| NDA020090 DIFLUCAN | Pfizer | December 23, 1993 | 36, latest February 12, 2024 2024: Labeling · 2023: Labeling · 2023: Labeling |
Generic approvals (13)
- ANDA076658DR Reddys Labs Inc · July 29, 2004
- ANDA076665Chartwell · July 29, 2004
- ANDA076766Baxter Hlthcare · July 29, 2004
- ANDA076736Hikma Farmaceutica · August 23, 2005
- ANDA077253Glenmark Pharms Ltd · January 25, 2006
- ANDA077731Aurobindo Pharma · October 7, 2008
- ANDA079104Inforlife · July 30, 2009
- ANDA079150Aurobindo Pharma · September 18, 2009
- ANDA078423Ani Pharms · March 7, 2011
- ANDA078698Hikma Farmaceutica · January 30, 2012
- ANDA078764Hikma Farmaceutica · January 30, 2012
- ANDA208963Zydus Pharms · February 16, 2017
- ANDA215738Zhejiang Poly Pharm · September 21, 2023
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.
-
May 15, 2017 · Class II · Terminated · D-0788-2017
Lack of assurance of sterility: customer complaints received for the presence of leaks.
Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1446, NDC 0338-6046-48 — Baxter Healthcare Corporation
-
January 5, 2017 · Class II · Terminated · D-0689-2017
Failed Dissolution Specifications
Fluconazole Tablets, USP, 200 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI — The Harvard Drug Group
-
January 5, 2017 · Class II · Terminated · D-0688-2017
Failed Dissolution Specifications
Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI — The Harvard Drug Group
-
December 28, 2016 · Class II · Terminated · D-0451-2017
Failed Dissolution Specifications; 18 month stability time point
Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India --- NDC 55111-145-12 — Dr. Reddy's Laboratories, Inc.
-
December 28, 2016 · Class II · Terminated · D-0449-2017
Failed Dissolution Specifications; 18 month stability time point
Flucanozole Tablets, USP, 50 mg, a) 30 count (NDC 55111-143-30) and b) 100 count (NDC 55111-143-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India — Dr. Reddy's Laboratories, Inc.
-
December 28, 2016 · Class II · Terminated · D-0450-2017
Failed Dissolution Specifications; 18 month stability time point
Flucanozole Tablets, USP, 100 mg, a) 30 count (NDC 55111-144-30) and b) 100 count (NDC 55111-144-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India — Dr. Reddy's Laboratories, Inc.
-
December 28, 2016 · Class II · Terminated · D-0452-2017
Failed Dissolution Specifications; 18 month stability time point
Flucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 count (NDC 55111-146-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India — Dr. Reddy's Laboratories, Inc.
-
December 6, 2016 · Class II · Terminated · D-0206-2017
Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.
Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1446, NDC 0338-6046-48. — Baxter Healthcare Corporation
-
December 23, 2014 · Class II · Terminated · D-0380-2015
Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.
Fluconazole Injection, USP, 200 mg/100 mL (2 mg/mL), 100 mL Single-Dose INTRAVIA Container bag, packaged in 10 x 100 mL Single Dose INTRAVIA container bags per carton, Rx only, Baxter Healthcare Corporation, Deerfield, I — Baxter Healthcare Corp.
-
January 29, 2014 · Class II · Terminated · D-1356-2014
Defective Container: Tamper evident ring failures discovered on some bottles.
GREENSTONE BRAND fluconazole for Oral Suspension, ORANGE FLAVORED, 40 mg/mL, when reconstituted, Rx only, Distributed by Greenstone LLC Peapack, NJ 07977. MADE IN INDIA. NDC 59762-5030-1 — Pfizer 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) — Diflucan, Roerig, effective April 2, 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 →