Fluconazole
Fluconazole is an antifungal medicine used to treat yeast (Candida) infections such as vaginal, mouth, throat and esophagus infections, to treat cryptococcal meningitis, and to help prevent candidiasis in bone marrow transplant patients.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 104 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
How we combine label and product data →
Fluconazole (Diflucan), an antifungal that has been a familiar first choice for vaginal yeast infections since about 1990 and is available generically, also treats Candida yeast infections of the mouth, throat and esophagus and cryptococcal meningitis (a fungal infection around the brain), and helps prevent yeast infections in bone marrow transplant patients. It is usually well tolerated, and the side effects people notice are mostly headache, nausea or stomach upset, though rare liver injury and severe skin or allergic reactions can occur. The main thing to check is your other medicines, since combining it with drugs like erythromycin, pimozide or quinidine can cause dangerous heart rhythm problems.
Clinical pearls
- For a vaginal yeast infection, a single dose is usually the whole treatment, taken with or without food.
- Higher doses in early pregnancy have been linked to birth defects, so tell your prescriber if you are or could become pregnant.
- Phenytoin, valproic acid, rifampin, isoniazid and sulfonylurea diabetes medicines were linked to more abnormal liver tests alongside fluconazole.
- Stop it and get checked for yellow skin or eyes, dark urine, or a rash that spreads, blisters or peels.
Patient information guide — a plain-language walkthrough of Fluconazole, written from its FDA label.
What Fluconazole is used for
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Fluconazole treats several fungal infections, with some uses limited to certain products.
- Vaginal yeast infections (Candida): Diflucan, fluconazole tablets, and fluconazole products labeled for tablet and suspension.
- Oropharyngeal (mouth and throat) and esophageal candidiasis: all supported products.
- Candida urinary tract infections, peritonitis and systemic infections including candidemia, disseminated candidiasis and pneumonia: effective in small open studies.
- Cryptococcal meningitis: all supported products.
- Prevention of candidiasis in bone marrow transplant patients receiving chemotherapy and/or radiation: all supported products.
How Fluconazole works
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Fluconazole blocks a fungal enzyme (lanosterol 14-α-demethylase) that makes ergosterol, an essential part of fungal cell membranes. Without normal sterols, fungal growth slows. Human cells are much less sensitive to this block.
Resistance is possible. Some fungi change the target enzyme or pump the drug out of their cells. Candida krusei is considered resistant.
Fluconazole dosage
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Fluconazole comes as a tablet, an oral suspension and an IV injection. Oral forms can be taken with or without food. Vaginal yeast infections are treated with one single oral dose. Other infections are usually treated once daily, often with a larger first-day dose, and the length of treatment depends on the infection and your response.
- The daily dose is the same by mouth or IV.
- Take the full course, since stopping early may lead to recurrence.
- People with AIDS and cryptococcal meningitis or recurrent mouth and throat candidiasis often need maintenance therapy.
Dosing details from the FDA-approved label
From the Fluconazole prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Vaginal candidiasis (adults)
- 150 mg as a single oral dose
- No need to adjust single dose therapy for impaired renal function
- Oropharyngeal candidiasis (adults)
- 200 mg on the first day, followed by 100 mg once daily
- Treat for at least 2 weeks to decrease the likelihood of relapse
- Esophageal candidiasis (adults)
- 200 mg on the first day, followed by 100 mg once daily
- Maximum: Doses up to 400 mg/day may be used
- Treat for a minimum of three weeks and at least two weeks after symptoms resolve
- Systemic Candida infections (adults)
- Optimal dosage and duration have not been established
- Doses of up to 400 mg daily have been used in open, noncomparative studies
- Candida urinary tract infections and peritonitis (adults)
- Daily doses of 50 to 200 mg have been used in open, noncomparative studies
- Acute cryptococcal meningitis (adults)
- 400 mg on the first day, followed by 200 mg once daily
- 400 mg once daily may be used based on medical judgment
- Treat 10 to 12 weeks after cerebrospinal fluid becomes culture negative
- Suppression of relapse of cryptococcal meningitis in adults with AIDS
- 200 mg once daily
- Prophylaxis in bone marrow transplantation (adults)
- 400 mg once daily
- If severe granulocytopenia is anticipated, start several days before neutropenia and continue 7 days after neutrophils rise above 1000 cells/mm3
- Oropharyngeal candidiasis (pediatric patients 6 months and older)
- 6 mg/kg on the first day, followed by 3 mg/kg once daily
- Treat for at least 2 weeks
- Impaired renal function, multiple doses
- Initial loading dose of 50 mg to 400 mg, then daily dose by creatinine clearance: >50 mL/min 100%
- ≤50 mL/min (no dialysis) 50%
- Hemodialysis 100% after each hemodialysis
- Kidney adjustment based on creatinine clearance
Read the label’s full dosing text
DOSAGE AND ADMINISTRATION Dosage and Administration in Adults Single Dose Vaginal candidiasis The recommended dosage of fluconazole for vaginal candidiasis is 150 mg as a single oral dose. Multiple Dose SINCE ORAL ABSORPTION IS RAPID AND ALMOST COMPLETE, THE DAILY DOSE OF FLUCONAZOLE IS THE SAME FOR ORAL (TABLETS AND SUSPENSION) AND INTRAVENOUS ADMINISTRATION. In general, a loading dose of twice the daily dose is recommended on the first day of therapy to result in plasma concentrations close to steady-state by the second day of therapy. The daily dose of fluconazole for the treatment of infections other than vaginal candidiasis should be based on the infecting organism and the patient's response to therapy. Treatment should be continued until clinical parameters or laboratory tests indicate that active fungal infection has subsided. An inadequate period of treatment may lead to recurrence of active infection. Patients with AIDS and cryptococcal meningitis or recurrent oropharyngeal candidiasis usually require maintenance therapy to prevent relapse. Oropharyngeal candidiasis The recommended dosage of fluconazole for oropharyngeal candidiasis is 200 mg on the first day, followed by 100 mg once daily. Clinical evidence of oropharyngeal candidiasis generally resolves within several days, but treatment should be continued for at least 2 weeks to decrease the likelihood of relapse. Esophageal candidiasis The recommended dosage of fluconazole for esophageal candidiasis is 200 mg on the first day, followed by 100 mg once daily. Doses up to 400 mg/day may be used, based on medical judgment of the patient's response to therapy. Patients with esophageal candidiasis should be treated for a minimum of three weeks and for at least two weeks following resolution of symptoms. Systemic Candida infections For systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia, optimal therapeutic dosage and duration of therapy have not been established. In open, noncomparative studies of small numbers of patients, doses of up to 400 mg daily have been used. Urinary tract infections and peritonitis For the treatment of Candida urinary tract infections and peritonitis, daily doses of 50 to 200 mg have been used in open, noncomparative studies of small numbers of patients.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Fluconazole side effects
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Common side effects
- Headache
- Nausea
- Stomach or abdominal pain
- Diarrhea
- Vomiting
- Skin rash
- Dizziness
- Taste changes
When to get medical help
- Get help right away for signs of a severe allergic reaction, such as swelling of the face or throat, itching or trouble breathing.
- Call your doctor if you develop a rash, especially one that spreads or blisters, or peeling skin.
- Call your doctor if you have signs of liver problems, such as yellow skin or eyes, dark urine, or unusual tiredness.
- Seek help for a fast or irregular heartbeat or fainting, since fluconazole can cause QT prolongation (a heart rhythm change).
- Report seizures right away.
- Tell your doctor about unusual bruising, bleeding or frequent infections, which can reflect low blood cell counts.
Fluconazole is generally well tolerated. Common side effects include:
- Headache
- Nausea
- Abdominal pain
- Diarrhea
- Vomiting
- Skin rash
- Dizziness and taste changes
Call your doctor promptly about a spreading rash, signs of liver problems, allergic reactions, seizures or heart rhythm changes.
Fluconazole warnings and precautions
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- Liver injury: rare but serious, sometimes fatal, mostly in people with serious underlying illness. Use caution with liver disease.
- Severe skin reactions: including Stevens-Johnson syndrome and toxic epidermal necrolysis.
- Anaphylaxis: rare severe allergic reaction.
- Heart rhythm: QT prolongation and torsade de pointes have been reported.
- Pregnancy: possible fetal harm, especially with high doses in the first trimester.
Fluconazole interactions
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Several medicines can clash with fluconazole.
- Erythromycin, pimozide and quinidine: contraindicated due to heart rhythm risk.
- Other QT-prolonging drugs processed by CYP3A4: should not be combined.
- Rifampin, phenytoin, isoniazid, valproic acid and oral sulfonylureas: higher chance of raised liver enzymes.
Interactions listed in the FDA-approved label
From the Fluconazole prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Oral contraceptives (ethinyl estradiol, levonorgestrel): With fluconazole 50 mg daily for 10 days there was no significant difference in AUC (ethinyl estradiol mean increase 6%, levonorgestrel 17%); with 200 mg daily, levonorgestrel AUC rose 25% and ethinyl estradiol AUC 38%, both significantly different from placebo.
- Oral contraceptive containing ethinyl estradiol and norethindrone (fluconazole 300 mg once weekly): Small increases in mean AUCs: ethinyl estradiol 24% and norethindrone 13% relative to placebo, with no decrease in ethinyl estradiol AUC in any individual subject.
Read the label’s full interactions text
Drug Interaction Studies (See PRECAUTIONS, Drug Interactions) Oral contraceptives: Oral contraceptives were administered as a single dose both before and after the oral administration of fluconazole 50 mg once daily for 10 days in 10 healthy women. There was no significant difference in ethinyl estradiol or levonorgestrel AUC after the administration of 50 mg of fluconazole. The mean increase in ethinyl estradiol AUC was 6% (range: –47 to 108%) and levonorgestrel AUC increased 17% (range: –33 to 141%). In a second study, twenty-five normal females received daily doses of both 200 mg fluconazole tablets or placebo for two, ten-day periods. The treatment cycles were one month apart with all subjects receiving fluconazole during one cycle and placebo during the other. The order of study treatment was random. Single doses of an oral contraceptive tablet containing levonorgestrel and ethinyl estradiol were administered on the final treatment day (Day 10) of both cycles. Following administration of 200 mg of fluconazole, the mean percentage increase of AUC for levonorgestrel compared to placebo was 25% (range: –12 to 82%) and the mean percentage increase for ethinyl estradiol compared to placebo was 38% (range: –11 to 101%). Both of these increases were statistically significantly different from placebo. A third study evaluated the potential interaction of once-weekly dosing of fluconazole 300 mg to 21 normal females taking an oral contraceptive containing ethinyl estradiol and norethindrone. In this placebo-controlled, double-blind, randomized, two-way crossover study carried out over three cycles of oral contraceptive treatment, fluconazole dosing resulted in small increases in the mean AUCs of ethinyl estradiol and norethindrone compared to similar placebo dosing. The mean AUCs of ethinyl estradiol and norethindrone increased by 24% (95% C.I. range: 18 to 31%) and 13% (95% C.I. range: 8 to 18%), respectively, relative to placebo.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Fluconazole
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- Do not use if allergic to fluconazole or its ingredients.
- Use caution if allergic to other azole antifungals.
- Tell your doctor about liver disease.
- Kidney problems may require a lower dose.
- Tell your doctor if you are pregnant or may become pregnant.
- Children have been treated in clinical trials with a side effect pattern similar to adults.
Fluconazole overdose
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Overdose has been reported with hallucinations and paranoid behavior. Treatment is supportive. Fluconazole is largely cleared through the urine, and a 3-hour hemodialysis session lowers blood levels by about 50%.
What Fluconazole does in the body
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Fluconazole is active against most Candida albicans, C. glabrata (many isolates are only intermediately susceptible), C. parapsilosis, C. tropicalis and Cryptococcus neoformans. Its action is mainly to slow fungal growth rather than kill the fungus. In healthy volunteers, it had small and inconsistent effects on testosterone and cortisol.
How your body processes Fluconazole
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Over 90% of an oral dose is absorbed, and food does not change exposure. Peak levels occur 1 to 2 hours after an oral dose, and the half-life is about 30 hours. Roughly 80% leaves in urine unchanged, so kidney problems can raise drug levels. It spreads into body fluids, including cerebrospinal fluid.
How to store Fluconazole
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Store tablets below 30°C (86°F). Store dry powder below 30°C (86°F). Store reconstituted suspension between 30°C (86°F) and 5°C (41°F) and discard unused portion after 2 weeks.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Fluconazole
81 supplements and herbal products have documented interactions with Fluconazole in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 4
- Moderate · 54
- Minor · 23
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Fluconazole: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Fluconazole — the kind of thing our pharmacy team would talk through with you at the counter.
What is fluconazole used for?
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Do I need to take it with food?
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What side effects should I expect?
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When should I call my doctor?
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Can I take it with my other medicines?
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Is it safe in pregnancy?
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Is Fluconazole available over the counter?
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When was Fluconazole first available?
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Who makes Fluconazole?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Fluconazole on HelloPharmacist
Fluconazole forms and strengths (how it comes)
Fluconazole is available in 3 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Diflucan and fluconazole tablets are used for vaginal yeast infections, oropharyngeal and esophageal candidiasis, and cryptococcal meningitis.
- Diflucan and fluconazole tablets are also used to decrease candidiasis in bone marrow transplant patients.
- Fluconazole tablets may be taken without regard to meals.
- Diflucan and fluconazole tablets treat vaginal candidiasis with a single oral dose.
Oral suspension
How this form is used
- Fluconazole for oral suspension is used for oropharyngeal and esophageal candidiasis and cryptococcal meningitis.
- Diflucan (tablets and suspension) is also used for vaginal candidiasis.
- Fluconazole for oral suspension is also used to decrease candidiasis in bone marrow transplant patients.
- Diflucan and fluconazole oral suspension are taken by mouth, with a daily dose matching the tablet and IV dose.
- Oral suspension is typically started with a loading dose of twice the daily dose on day 1.
Injection
How this form is used
- Fluconazole in Sodium Chloride Injection is used for oropharyngeal and esophageal candidiasis and cryptococcal meningitis.
- Fluconazole in Sodium Chloride Injection is also used to decrease candidiasis in bone marrow transplant patients receiving chemotherapy and/or radiation.
- Fluconazole injection is given through a vein, and its daily dose is the same as the oral dose.
- Fluconazole injection typically starts with a loading dose of twice the daily dose on day 1.
Fluconazole on the U.S. market: products, makers and brands
How Fluconazole appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
81 companies list 528 Fluconazole product records with the FDA, mostly as tablet, oral suspension, injection; the earliest marketing or approval year on record is 1990. Brand names on the directory include Diflucan, Fluconazole in Sodium Chloride; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (18) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Fluconazole is used (Medicaid data)
A general measure of how commonly Fluconazole is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Fluconazole is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Fluconazole prescribed? Of the 1,601 medications we measure, Fluconazole ranks #58 by Medicaid prescriptions — more than 96% of them.
Utilization by Fluconazole product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
fluconazole 150 MG Oral Tablet Most dispensed
Summed across the 10 of 159 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197699
fluconazole 200 MG Oral Tablet
Summed across the 14 of 206 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197700
fluconazole 100 MG Oral Tablet
Summed across the 13 of 163 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197698
fluconazole 40 MG/ML Oral Suspension
Summed across the 4 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 310353
fluconazole 10 MG/ML Oral Suspension
Summed across the 3 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 310352
fluconazole 50 MG Oral Tablet
Summed across the 6 of 71 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197701
200 ML fluconazole 2 MG/ML Injection
Summed across the 3 of 16 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1721314
100 ML fluconazole 2 MG/ML Injection
Summed across the 2 of 18 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1721315
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Fluconazole, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 55 of 648 listed Fluconazole NDCs with Medicaid activity.
Compare Fluconazole products
A representative set of FDA-listed product records for Fluconazole — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 200 mg/100 mL | Intravenous | Baxter Healthcare Company | ANDA | View NDC → |
| 400 mg/200 mL | Intravenous | Baxter Healthcare Company | ANDA | View NDC → |
| 200 mg/100 mL | Intravenous | Baxter Healthcare Corporation × 2 listings | ANDA | View NDC → |
| 400 mg/200 mL | Intravenous | Baxter Healthcare Corporation × 2 listings | ANDA | View NDC → |
| 2 mg/mL | Intravenous | Hikma Pharmaceuticals USA Inc. × 15 listings | ANDA | View NDC → |
| 200 mg/100 mL | Intravenous | Hospira, Inc | ANDA | View NDC → |
| 400 mg/200 mL | Intravenous | Hospira, Inc | ANDA | View NDC → |
| 2 mg/mL | Intravenous | Hospira, Inc. × 2 listings | ANDA | View NDC → |
| 2 mg/mL | Intravenous | Sagent Pharmaceuticals × 6 listings | ANDA | View NDC → |
| 💊Oral suspension | ||||
| 10 mg/mL | Oral | Aurobindo Pharma Limited × 3 listings | ANDA | View NDC → |
| 40 mg/mL | Oral | Aurobindo Pharma Limited × 3 listings | ANDA | View NDC → |
| 10 mg/mL | Oral | Greenstone LLC × 2 listings | NDA AUTHORIZED GENERIC | View NDC → |
| 40 mg/mL | Oral | Greenstone LLC × 2 listings | NDA AUTHORIZED GENERIC | View NDC → |
| 40 mg/mL | Oral | Hainan Poly Pharm. Co., Ltd. | ANDA | View NDC → |
| 10 mg/mL | Oral | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| 40 mg/mL | Oral | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| 10 mg/mL | Oral | NorthStar Rx LLC × 3 listings | ANDA | View NDC → |
| 40 mg/mL | Oral | NorthStar Rx LLC × 3 listings | ANDA | View NDC → |
| 10 mg/mL | Oral | Rising Health, LLC | ANDA | View NDC → |
| 40 mg/mL | Oral | Rising Health, LLC | ANDA | View NDC → |
| 10 mg/mL | Oral | Rising Pharma Holdings, Inc. × 2 listings | ANDA | View NDC → |
| 40 mg/mL | Oral | Rising Pharma Holdings, Inc. × 2 listings | ANDA | View NDC → |
| 350 mg/35 mL | Oral | Roerig × 2 listings | NDA | View NDC → |
| 1400 mg/35 mL | Oral | Roerig × 3 listings | NDA | View NDC → |
| 40 mg/mL | Oral | Slate Run Pharmaceuticals | ANDA | View NDC → |
| 40 mg/mL | Oral | Zhejiang Poly Pharm. Co., Ltd. | ANDA | View NDC → |
| 💊Tablet | ||||
| 100 mg | Oral | A-S Medication Solutions × 6 listings | ANDA | View NDC → |
| 150 mg | Oral | A-S Medication Solutions × 13 listings | ANDA | View NDC → |
| 200 mg | Oral | A-S Medication Solutions × 6 listings | ANDA | View NDC → |
| 50 mg | Oral | Acetris Health, Llc | ANDA | View NDC → |
| 100 mg | Oral | Acetris Health, Llc | ANDA | View NDC → |
| 150 mg | Oral | Acetris Health, Llc | ANDA | View NDC → |
| 200 mg | Oral | Acetris Health, Llc | ANDA | View NDC → |
| 100 mg | Oral | American Health Packaging × 3 listings | ANDA | View NDC → |
| 200 mg | Oral | American Health Packaging × 3 listings | ANDA | View NDC → |
| 50 mg | Oral | ANI Pharmaceuticals, Inc. × 3 listings | ANDA | View NDC → |
| 100 mg | Oral | ANI Pharmaceuticals, Inc. × 3 listings | ANDA | View NDC → |
| 150 mg | Oral | ANI Pharmaceuticals, Inc. × 3 listings | ANDA | View NDC → |
| 200 mg | Oral | ANI Pharmaceuticals, Inc. × 3 listings | ANDA | View NDC → |
| 150 mg | Oral | Asclemed USA, Inc. × 2 listings | ANDA | View NDC → |
| 50 mg | Oral | Asclemed Usa Inc. | ANDA | View NDC → |
| 100 mg | Oral | Asclemed Usa Inc. | ANDA | View NDC → |
| 150 mg | Oral | Asclemed Usa Inc. | ANDA | View NDC → |
| 200 mg | Oral | Asclemed Usa Inc. | ANDA | View NDC → |
| 50 mg | Oral | Aurobindo Pharma Limited × 3 listings | ANDA | View NDC → |
| 50 mg | — | Aurobindo Pharma Limited | DRUG FOR FURTHER PROCESSING | View NDC → |
| 100 mg | — | Aurobindo Pharma Limited | DRUG FOR FURTHER PROCESSING | View NDC → |
| 100 mg | Oral | Aurobindo Pharma Limited × 3 listings | ANDA | View NDC → |
| 150 mg | Oral | Aurobindo Pharma Limited × 3 listings | ANDA | View NDC → |
| 150 mg | — | Aurobindo Pharma Limited | DRUG FOR FURTHER PROCESSING | View NDC → |
| 200 mg | — | Aurobindo Pharma Limited | DRUG FOR FURTHER PROCESSING | View NDC → |
| 200 mg | Oral | Aurobindo Pharma Limited × 3 listings | ANDA | View NDC → |
| 100 mg | Oral | AvPAK × 3 listings | ANDA | View NDC → |
| 200 mg | Oral | AvPAK × 3 listings | ANDA | View NDC → |
| 50 mg | Oral | BluePoint Laboratories × 3 listings | ANDA | View NDC → |
| 100 mg | Oral | BluePoint Laboratories × 3 listings | ANDA | View NDC → |
| 150 mg | Oral | BluePoint Laboratories × 3 listings | ANDA | View NDC → |
| 200 mg | Oral | BluePoint Laboratories × 3 listings | ANDA | View NDC → |
| 50 mg | Oral | Bryant Ranch Prepack × 5 listings | ANDA | View NDC → |
| 100 mg | Oral | Bryant Ranch Prepack × 13 listings | ANDA | View NDC → |
| 150 mg | Oral | Bryant Ranch Prepack × 9 listings | ANDA | View NDC → |
| 200 mg | Oral | Bryant Ranch Prepack × 5 listings | ANDA | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | Alivus Life Sciences Limited | BULK INGREDIENT | View NDC → |
| 50 kg/50 kg | — | Aurobindo Pharma Limited × 2 listings | BULK INGREDIENT | View NDC → |
| 30 kg/30 kg | — | Cipla Ltd. | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Dr.Reddy's Laboratories Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Inke SA | BULK INGREDIENT | View NDC → |
| 1 g/g | — | Kalchem International inc | BULK INGREDIENT | View NDC → |
| 1 g/g | — | Letco Medical, Llc | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING | View NDC → |
| 1 kg/kg | — | Matrix Pharmacorp Private Limited | BULK INGREDIENT | View NDC → |
| 1 g/g | — | Medisca Inc. | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING | View NDC → |
| 1 kg/kg | — | Minsheng Group Shaoxing Pharmaceutical Co., LTD. | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Pfizer Ireland Pharmaceuticals Unlimited Company | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Professional Compounding Centers of America dba PCCA | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING | View NDC → |
| 1 kg/kg | — | Quimica Sintetica S.A. | BULK INGREDIENT | View NDC → |
| 1 g/g | — | Spectrum Laboratory Products, Inc. | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Viatris Pharmaceuticals LLC | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Virupaksha Organics Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Zydus Lifesciences Limited | BULK INGREDIENT | View NDC → |
Showing 200 of 528 products — FDA National Drug Code Directory. See every product, package size and price: browse all 528 Fluconazole NDCs →
Fluconazole side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Fluconazole — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Fluconazole in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Fluconazole FDA approval history
How Fluconazole went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Fluconazole recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Fluconazole recalls since July 2021.
✅No Fluconazole recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 4450 4 dose forms · 13 strengths
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Dose form (SCDF) Injection RxCUI 1721309In current FDA listingsClinical drug / strength (SCD) 50 ML fluconazole 2 MG/MLRxCUI 1721310100 ML fluconazole 2 MG/MLRxCUI 1721315200 ML fluconazole 2 MG/MLRxCUI 1721314 -
Dose form (SCDF) Oral Capsule RxCUI 372208No current FDA listingClinical drug / strength (SCD) 50 MGRxCUI 199747100 MGRxCUI 199950150 MGRxCUI 199745200 MGRxCUI 199746 -
Dose form (SCDF) Oral Suspension RxCUI 372209In current FDA listings -
Dose form (SCDF) Oral Tablet RxCUI 372210In current FDA listings
Look up RxCUI 4450 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Fluconazole supply and shortage status
Whether Fluconazole is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Fluconazole brand names
Fluconazole is sold under 2 brand names in the FDA directory — Diflucan, Fluconazole in Sodium Chloride. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Fluconazole: manufacturers and labelers
81 companies list Fluconazole products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, Remedyrepack Inc., A-S Medication Solutions. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
…and 57 more on the FDA NDC directory.
Fluconazole drug class (RxNorm)
Fluconazole belongs to the Azole Antifungal class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Fluconazole page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Roerig is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →