Fluconazole 150 mg Tablet, 12-count — NDC 68462-119-44 (Billing 68462-0119-44)
This is a package of 12 tablets of Fluconazole 150 mg Tablet from Glenmark Pharmaceuticals Inc., USA, marketed since Nov 2020 and currently FDA-listed; retail pharmacies pay about $0.4698 per tablet (NADAC). It is the main listing for this product, which comes in 2 package sizes.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 022141
- GCN: 42193
- GPI-14 (Medi-Span): 11407015000325
- HICL (First Databank): 004868
- AHFS class code: 08:14.08.00
- RxCUI (RxNorm): 197698
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Azole Antifungal class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It treats yeast infections such as vaginal, mouth, throat and esophagus infections. It also treats cryptococcal meningitis and helps prevent candidiasis in bone marrow transplant p...
- No. Oral fluconazole works the same with or without food, so take it whichever is easier for you. Follow your prescriber's directions for how often and for how long.
- Most people tolerate it well. The most common ones are headache, nausea, stomach pain, diarrhea and rash, and these are usually mild to moderate.
- Call if you notice a rash that spreads or blisters, yellow skin or eyes, dark urine, a racing or irregular heartbeat, fainting or seizures. Swelling of the face or trouble breathin...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Fluconazole — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.470 | $5.64 / 12 tablet |
| Medicaid paysCMS SDUD · 12 mo | $5.12 | $61.38 / 12 tablet |
| Medicare drug plans payPart D · Q2 2026 | $0.4361 | $5.23 / 12 tablet |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q4 2025
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 68462-0119-40 68462-119-40 | 1 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK | $0.4698 / ea | $0.47 | 2020-11-20 | — | Active |
| 68462-0119-44 You're viewing this Main listing | 12 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK | $0.4698 / ea | $5.64 | 2020-11-20 | — | Active |
This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.4698 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 94% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 68462-0119-40?
What NDC number is used to bill for this package of Fluconazole 150 mg Tablet?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Fluconazole 150 mg 16714-0692-11 | NorthStar | 12 tablets | $0.470 | AB | Availability likely | — |
| Fluconazole 150 mg 55111-0145-12 | Dr. | 12 tablets | $0.470 | AB | Availability likely | — |
| Fluconazole 150 mg 57237-0005-11 | Rising | 12 tablets | $0.470 | AB | Availability likely | — |
| Fluconazole 150 mg 62135-0132-77 | Chartwell | 1 tablet | $0.470 | AB | Availability likely | — |
| Fluconazole 150 mg 62559-0992-12 | ANI | 12 tablets | $0.470 | AB | Availability likely | — |
| Fluconazole 150 mg 68001-0253-17 | BluePoint | 12 tablets | $0.470 | AB | Availability likely | — |
| Fluconazole 150 mgthis 68462-0119-44 | Glenmark | 12 tablets | $0.470 | AB | Availability likely | — |
| Fluconazole 150 mg 43063-0642-02 | PD-Rx | 2 tablets | — | AB | FDA listed | — |
| Fluconazole 150 mg 50090-2195-00 | A-S | 1 tablet | — | AB | FDA listed | — |
| fluconazole 150 mg 50090-4425-00 | A-S | 1 tablet | — | AB | FDA listed | — |
| Fluconazole 150 mg 50090-5764-00 | A-S | 1 tablet | — | AB | FDA listed | — |
| Fluconazole 150 mg 50090-6842-00 | A-S | 1 tablet | — | AB | FDA listed | — |
| Fluconazole 150 mg 51407-0426-12 | Golden | 12 tablets | — | AB | FDA listed | — |
| Fluconazole 150 mg 51655-0435-07 | Northwind | 7 tablets | — | AB | FDA listed | — |
| Fluconazole 150 mg 60760-0950-01 | St. | 1 tablet | — | AB | FDA listed | — |
| Fluconazole 150 mg 63187-0584-01 | Proficient | 1 tablet | — | AB | FDA listed | — |
| Fluconazole 150 mg 65862-0060-11 | Aurobindo | 12 tablets | — | — | FDA listed | — |
| Fluconazole 150 mg 68071-2557-01 | NuCare | 12 tablets | — | AB | FDA listed | — |
| Fluconazole 150 mg 68071-3474-01 | NuCare | 12 tablets | — | AB | FDA listed | — |
| Fluconazole 150 mg 68071-3515-02 | NuCare | 2 tablets | — | AB | FDA listed | — |
| Fluconazole 150 mg 68071-3578-01 | NuCare | 12 tablets | — | AB | FDA listed | — |
| Fluconazole 150 mg 68788-7293-01 | Preferred | 1 tablet | — | AB | FDA listed | — |
| Fluconazole 150 mg 70518-4332-00 | REMEDYREPACK | 12 tablets | — | AB | FDA listed | — |
| Fluconazole 150 mg 70518-4336-00 | REMEDYREPACK | 12 tablets | — | AB | FDA listed | — |
| fluconazole 150 mg 70710-1139-01 | Zydus | 100 tablets | — | AB | FDA listed | — |
| fluconazole 150 mg 70771-1065-01 | Zydus | 100 tablets | — | AB | FDA listed | — |
| fluconazole 150 mg 71205-0081-01 | Proficient | 1 tablet | — | AB | FDA listed | — |
| Fluconazole 150 mg 71205-0563-01 | Proficient | 1 tablet | — | AB | FDA listed | — |
| Fluconazole 150 mg 71205-0796-01 | Proficient | 1 tablet | — | AB | FDA listed | — |
| Fluconazole 150 mg 71335-1268-01 | Bryant | 12 tablets | — | AB | FDA listed | — |
| Fluconazole 150 mg 71335-1448-01 | Bryant | 1 tablet | — | AB | FDA listed | — |
| Fluconazole 150 mg 71335-2268-01 | Bryant | 1 tablet | — | AB | FDA listed | — |
| Fluconazole 150 mg 72189-0143-01 | direct | 1 tablet | — | AB | FDA listed | — |
| fluconazole 150 mg 72189-0149-01 | direct | 1 tablet | — | AB | FDA listed | — |
| Fluconazole 150 mg 72189-0342-01 | Direct | 1 tablet | — | AB | FDA listed | — |
| Fluconazole 150 mg 72789-0209-02 | PD-Rx | 2 tablets | — | AB | Discontinued | — |
| Fluconazole 150 mg 76420-0164-01 | Asclemed | 1 tablet | — | AB | FDA listed | — |
| Fluconazole 150 mg 76420-0587-01 | Asclemed | 1 tablet | — | AB | FDA listed | — |
| Fluconazole 150 mg 77771-0398-11 | Radha | 1 tablet | — | AB | FDA listed | — |
| Fluconazole 150 mg 82868-0033-86 | Northwind | 2 tablets | — | AB | FDA listed | — |
| Fluconazole 150 mg 82982-0070-02 | Pharmasource | 2 tablets | — | AB | FDA listed | — |
| Fluconazole 150 mg 85766-0103-12 | Sportpharm | 12 tablets | — | AB | FDA listed | — |
| Fluconazole 150 mg 85766-0158-01 | Sportpharm | 12 tablets | — | AB | FDA listed | — |
| Fluconazole 150 mg 85766-0167-12 | Sportpharm | 12 tablets | — | AB | FDA listed | — |
| Fluconazole 150 mg 87063-0205-01 | ASCLEMED | 1 tablet | — | AB | FDA listed | — |
| Fluconazole 150 mg 85534-0049-00 | HAWAII | 1 tablet | — | AB | FDA listed | — |
| Fluconazole 150 mg 67296-2274-01 | Redpharm | 1 tablet | — | AB | FDA listed | — |
| Fluconazole 150 mg 60760-0803-01 | St. | 1 tablet | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Sep 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Fluconazole tablets are 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, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. 3.
Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted.
Prophylaxis: Fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.
⏱️ Dosage and Administration ▾
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 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.
Cryptococcal meningitis: The recommended dosage for treatment of acute cryptococcal meningitis is 400 mg on the first day, followed by 200 mg once daily. A dosage of 400 mg once daily may be used, based on medical judgment of the patient’s response to therapy. The recommended duration of treatment for initial therapy of cryptococcal meningitis is 10 to 12 weeks after the cerebrospinal fluid becomes culture negative.
The recommended dosage of fluconazole for suppression of relapse of cryptococcal meningitis in patients with AIDS is 200 mg once daily. Prophylaxis in patients undergoing bone marrow transplantation: The recommended fluconazole daily dosage for the prevention of candidiasis in patients undergoing bone marrow transplantation is 400 mg, once daily. Patients who are anticipated to have severe granulocytopenia (less than 500 neutrophils cells/mm 3 ) should start fluconazole prophylaxis several days before the anticipated onset of neutropenia, and continue for 7 days after the neutrophil count rises above 1000 cells/mm 3 .
Dosage and Administration in Pediatric Patient: Oropharyngeal candidiasis: The recommended dosage of fluconazole for oropharyngeal candidiasis in pediatric patients 6 months and older is 6 mg/kg on the first day, followed by 3 mg/kg once daily. Treatment should be administered for at least 2 weeks to decrease the likelihood of relapse. Esophageal candidiasis: For the treatment of esophageal candidiasis, the recommended dosage of fluconazole in pediatric patients 6 months and older is 6 mg/kg on the first day, followed by 3 mg/kg once daily.
Doses up to 12 mg/kg/day may be used, based on medical judgment of the patient’s response to therapy.… [Excerpted — this section continues on DailyMed.]
⛔ Contraindications ▾
CONTRAINDICATIONS Fluconazole tablets are contraindicated in patients who have shown hypersensitivity to fluconazole or to any of its excipients. There is no information regarding cross-hypersensitivity between fluconazole and other azole antifungal agents. Caution should be used in prescribing fluconazole to patients with hypersensitivity to other azoles.
Coadministration of other drugs known to prolong the QT interval and which are metabolized via the enzyme CYP3A4 such as erythromycin, pimozide, and quinidine are contraindicated in patients receiving fluconazole (see CLINICAL PHARMACOLOGY: Drug Interaction Studies and PRECAUTIONS ).
⚠️ Warnings ▾
WARNINGS (1) Hepatic injury: Fluconazole should be administered with caution to patients with liver dysfunction. Fluconazole has been associated with rare cases of serious hepatic toxicity, including fatalities primarily in patients with serious underlying medical conditions. In cases of fluconazole-associated hepatotoxicity, no obvious relationship to total daily dose, duration of therapy, sex, or age of the patient has been observed.
Fluconazole hepatotoxicity has usually, but not always, been reversible on discontinuation of therapy. Patients who develop abnormal liver function tests during fluconazole therapy should be monitored for the development of more severe hepatic injury. Fluconazole should be discontinued if clinical signs and symptoms consistent with liver disease develop that may be attributable to fluconazole.
(2) Anaphylaxis: In rare cases, anaphylaxis has been reported. (3) Dermatologic: Exfoliative skin disorders during treatment with fluconazole have been reported. Fatal outcomes have been reported in patients with serious underlying diseases.
Patients with deep seated fungal infections who develop rashes during treatment with fluconazole should be monitored closely and the drug discontinued if lesions progress. Fluconazole should be discontinued in patients treated for superficial fungal infection who develop a rash that may be attributed to fluconazole. (4) Potential for fetal harm: There are no adequate and well-controlled clinical trials of fluconazole in pregnant women.
Case reports describe a pattern of distinct congenital anomalies in infants exposed in utero to high dose maternal fluconazole (400 to 800 mg/day) during most or all of the first trimester. These reported anomalies are similar to those seen in animal studies. If fluconazole is used during pregnancy or if the patient becomes pregnant while taking the drug, the patient should be informed of the potential hazard to the fetus.
Effective contraceptive measures should be considered in women of child-bearing potential who are being treated with fluconazole 400 to 800 mg/day and should continue throughout the treatment period and for approximately 1 week (5 to 6 half-lives) after the final dose. Epidemiological studies suggest a potential risk of spontaneous abortion and congenital abnormalities in infants whose mothers were treated with 150 mg of fluconazole as a single or repeated dose in the first trimester, but these epidemiological studies have limitations and these findings have not been confirmed in controlled clinical trials (see PRECAUTIONS: Pregnancy ).
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Fluconazole is generally well tolerated. In some patients, particularly those with serious underlying diseases such as AIDS and cancer, changes in renal and hematological function test results and hepatic abnormalities have been observed during treatment with fluconazole and comparative agents, but the clinical significance and relationship to treatment is uncertain. In Patients Receiving a Single Dose for Vaginal Candidiasis: During comparative clinical studies conducted in the United States, 448 patients with vaginal candidiasis were treated with fluconazole, 150 mg single dose.
The overall incidence of side effects possibly related to fluconazole was 26%. In 422 patients receiving active comparative agents, the incidence was 16%. The most common treatment-related adverse events reported in the patients who received 150 mg single dose fluconazole for vaginitis were headache (13%), nausea (7%), and abdominal pain (6%).
Other side effects reported with an incidence equal to or greater than 1% included diarrhea (3%), dyspepsia (1%), dizziness (1%), and taste perversion (1%). Most of the reported side effects were mild to moderate in severity. Rarely, angioedema and anaphylactic reaction have been reported in marketing experience.
In Patients Receiving Multiple Doses for Other Infections: Sixteen percent of over 4000 patients treated with fluconazole in clinical trials of 7 days or more experienced adverse events. Treatment was discontinued in 1.5% of patients due to adverse clinical events and in 1.3% of patients due to laboratory test abnormalities. Clinical adverse events were reported more frequently in HIV infected patients (21%) than in non-HIV infected patients (13%); however, the patterns in HIV infected and non-HIV infected patients were similar.
The proportions of patients discontinuing therapy due to clinical adverse events were similar in the two groups (1.5%). The following treatment-related clinical adverse events occurred at an incidence of 1% or greater in 4048 patients receiving fluconazole for 7 or more days in clinical trials: nausea 3.7%, headache 1.9%, skin rash 1.8%, vomiting 1.7%, abdominal pain 1.7%, and diarrhea 1.5%. Hepato-biliary: In combined clinical trials and marketing experience, there have been rare cases of serious hepatic reactions during treatment with fluconazole (see WARNINGS ).
The spectrum of these hepatic reactions has ranged from mild transient elevations in transaminases to clinical hepatitis, cholestasis and fulminant hepatic failure, including fatalities. Instances of fatal hepatic reactions were noted to occur primarily in patients with serious underlying medical conditions (predominantly AIDS or malignancy) and often while taking multiple concomitant medications. Transient hepatic reactions, including hepatitis and jaundice, have occurred among patients with no other identifiable risk factors.
In each of these cases, liver function returned to baseline on discontinuation of fluconazole. In two comparative trials evaluating the efficacy of fluconazole for the suppression of relapse of cryptococcal meningitis, a statistically significant increase was observed in median AST (SGOT) levels from a baseline value of 30 IU/L to 41 IU/L in one trial and 34 IU/L to 66 IU/L in the other. The overall rate of serum transaminase elevations of more than 8 times the upper limit of normal was approximately 1% in fluconazole-treated patients in clinical trials.
These elevations occurred in patients with severe underlying disease, predominantly AIDS or malignancies, most of whom were receiving multiple concomitant medications, including many known to be hepatotoxic. The incidence of abnormally elevated serum transaminases was greater in patients taking fluconazole concomitantly with one or more of the following medications: rifampin, phenytoin, isoniazid, valproic acid, or oral sulfonylurea hypoglycemic agents. Post-Marketing Experience In addition, the following adverse events have… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects. Potential for Fetal Harm: Use in pregnancy should be avoided except in patients with severe or potentially life-threatening fungal infections in whom fluconazole may be used if the anticipated benefit outweighs the possible risk to the fetus. A few published case reports describe a pattern of distinct congenital anomalies in infants exposed in utero to high dose maternal fluconazole (400 to 800 mg/day) during most or all of the first trimester.
These reported anomalies are similar to those seen in animal studies. Effective contraceptive measures should be considered in women of child-bearing potential who are being treated with fluconazole 400 to 800 mg/day and should continue throughout the treatment period and for approximately 1 week (5 to 6 half-lives) after the final dose. If fluconazole is used during pregnancy, or if the patient becomes pregnant while taking the drug, the patient should be informed of the potential hazard to the fetus.
Spontaneous abortions and congenital abnormalities have been suggested as potential risks associated with 150 mg of fluconazole as a single or repeated dose in the first trimester of pregnancy based on retrospective epidemiological studies. There are no adequate and well-controlled studies of fluconazole in pregnant women (see WARNINGS: Potential for Fetal Harm ). Human Data Case reports describe a distinctive and rare pattern of birth defects among infants whose mothers received high-dose (400 to 800 mg/day) fluconazole during most or all of the first trimester of pregnancy.
The features seen in these infants include brachycephaly, abnormal facies, abnormal calvarial development, cleft palate, femoral bowing, thin ribs and long bones, arthrogryposis, and congenital heart disease. These effects are similar to those seen in animal studies. Epidemiological studies suggest a potential risk of spontaneous abortion and congenital abnormalities in infants whose mothers were treated with 150 mg of fluconazole as a single or repeated dose in the first trimester, but these epidemiological studies have limitations and these findings have not been confirmed in controlled clinical trials.
Animal Data Fluconazole was administered orally to pregnant rabbits during organogenesis in two studies at doses of 5 mg/kg, 10 mg/kg, and 20 mg/kg and at 5 mg/kg, 25 mg/kg, and 75 mg/kg, respectively. Maternal weight gain was impaired at all dose levels (approximately 0.25 to 4 times the 400 mg clinical dose based on body surface area [BSA] comparison), and abortions occurred at 75 mg/kg (approximately 4 times the 400 mg clinical dose based on BSA); no adverse fetal effects were observed. In several studies in which pregnant rats received fluconazole orally during organogenesis, maternal weight gain was impaired and placental weights were increased at 25 mg/kg.
There were no fetal effects at 5 mg/kg or 10 mg/kg; increases in fetal anatomical variants (supernumerary ribs, renal pelvis dilation) and delays in ossification were observed at 25 mg/kg and 50 mg/kg and higher doses. At doses ranging from 80 to 320 mg/kg (approximately 2 to 8 times the 400 mg clinical dose based on BSA), embryolethality in rats was increased and fetal abnormalities included wavy ribs, cleft palate, and abnormal craniofacial ossification. These effects are consistent with the inhibition of estrogen synthesis in rats and may be a result of known effects of lowered estrogen on pregnancy, organogenesis, and parturition.
🧒 Pediatric Use ▾
Pediatric Use Use in Pediatric Patients for the Treatment of Oropharyngeal Candidiasis An open-label, randomized, controlled trial has shown fluconazole to be effective in the treatment of oropharyngeal candidiasis in pediatric patients 6 months to 13 years of age (see CLINICAL STUDIES ). Use in Pediatric Patients for the Treatment of Candida Esophagitis, Systemic Candida Infections, or Cryptococcal Meningitis The use of fluconazole in pediatric patients with cryptococcal meningitis, Candida esophagitis, or systemic Candida infections is supported by the efficacy shown for these indications in adults and by the results from several small noncomparative pediatric clinical studies.
In addition, pharmacokinetic studies in pediatric patients (see CLINICAL PHARMACOLOGY ) have established a dose proportionality between pediatric patients and adults (see DOSAGE AND ADMINISTRATION ). In a noncomparative study of fluconazole administered to pediatric patients (from birth to less than 17 years) with serious systemic fungal infections, most of which were candidemia, the effectiveness of fluconazole was similar to that reported for the treatment of candidemia in adults. Of 17 subjects with culture-confirmed candidemia, 11 of 14 (79%) with baseline symptoms (3 were asymptomatic) had a clinical cure; 13/15 (87%) of evaluable patients had a mycologic cure at the end of treatment but two of these patients relapsed at 10 and 18 days, respectively, following cessation of therapy.
The efficacy of fluconazole for the suppression of cryptococcal meningitis was successful in 4 of 5 pediatric patients (4 years to 10 years of age) treated in a compassionate-use study of fluconazole for the treatment of life-threatening or serious mycosis. There are limited clinical data to support the efficacy of fluconazole for the primary treatment of cryptococcal meningitis in pediatric patients. The safety profile of fluconazole has been studied in 577 pediatric patients from 1 day to 17 years of age who received doses ranging from 1 to 15 mg/kg/day for 1 to 1,616 days (see ADVERSE REACTIONS ).
Use in Pediatric Patients on Extracorporeal Membrane Oxygenation (ECMO) A prospective, open-label, single-center study was conducted to determine the PK and safety of fluconazole in pediatric patients (ages: from birth to 17 years of age) on ECMO (see CLINICAL PHARMACOLOGY). A loading dose of 35-mg/kg is recommended in pediatric patients on ECMO due to increased volume of distribution (see DOSAGE AND ADMINISTRATION ). Use in Prophylaxis of Invasive Candida Infections in Pediatric Patients (premature infants weighing less than 750 grams at birth) Safety and effectiveness of fluconazole tablets for the prophylaxis of invasive candidiasis in pediatric patients (premature infants weighing less than 750 grams at birth) have not been established.
A prospective, randomized, double-blind, placebo-controlled, multicenter trial was conducted in premature infants weighing less than 750 grams at birth to evaluate the efficacy and safety of prophylactic fluconazole tablets 6-mg/kg administered twice weekly for 6 weeks versus placebo (NCT00734539). Efficacy was assessed using the endpoint of death or candidiasis by study day 49. The results are summarized in Table 4.
Table 4: Death or Candidiasis by Day 49 in Premature Infants Receiving Fluconazole Prophylaxis Fluconazole (N=188) n (%) Placebo (N=173) n (%) P-value Difference (95% CI) Death or candidiasis* 33 (17.6) 38 (22.0) 0.2954 -4.4(-12.6, 3.8) Components of endpoint** Death Candidiasis Missing 27 (14.4) 6 (3.2) 2 (1.0) 25 (14.5) 16 (9.2) 1 (0.5) * Subjects with missing data are imputed as having candidiasis or died. **Subjects may be counted more than once as two fluconazole subjects and four placebo subjects diagnosed with candidiasis subsequently died by day 49.
The most common fatal serious adverse reactions in the fluconazole tablets vs placebo arms, respectively, were necrotizing enterocolitis (NEC), 9 (5%) vs 9 (5%); neonata… [Excerpted — this section continues on DailyMed.]
🧓 Geriatric Use ▾
Geriatric Use In non-AIDS patients, side effects possibly related to fluconazole treatment were reported in fewer patients aged 65 and older (9%, n =339) than for younger patients (14%, n=2240). However, there was no consistent difference between the older and younger patients with respect to individual side effects. Of the most frequently reported (>1%) side effects, rash, vomiting, and diarrhea occurred in greater proportions of older patients.
Similar proportions of older patients (2.4%) and younger patients (1.5%) discontinued fluconazole therapy because of side effects. In post-marketing experience, spontaneous reports of anemia and acute renal failure were more frequent among patients 65 years of age or older than in those between 12 and 65 years of age. Because of the voluntary nature of the reports and the natural increase in the incidence of anemia and renal failure in the elderly, it is however not possible to establish a causal relationship to drug exposure.
Controlled clinical trials of fluconazole did not include sufficient numbers of patients aged 65 and older to evaluate whether they respond differently from younger patients in each indication. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Fluconazole is primarily cleared by renal excretion as unchanged drug.
Because elderly patients are more likely to have decreased renal function, care should be taken to adjust dose based on creatinine clearance. It may be useful to monitor renal function (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION ).
🆘 Overdosage ▾
OVERDOSAGE There have been reports of overdose with fluconazole accompanied by hallucination and paranoid behavior. In the event of overdose, symptomatic treatment (with supportive measures and gastric lavage if clinically indicated) should be instituted. Fluconazole is largely excreted in urine.
A 3-hour hemodialysis session decreases plasma levels by approximately 50%. In mice and rats receiving very high doses of fluconazole, clinical effects in both species included decreased motility and respiration, ptosis, lacrimation, salivation, urinary incontinence, loss of righting reflex, and cyanosis; death was sometimes preceded by clonic convulsions.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Pharmacokinetics and Metabolism The pharmacokinetic properties (PK) of fluconazole are similar following administration by the intravenous or oral routes. In normal volunteers, the bioavailability of orally administered fluconazole is over 90% compared with intravenous administration. Bioequivalence was established between the 100 mg tablet and both suspension strengths when administered as a single 200 mg dose.
Peak plasma concentrations (C max ) in fasted normal volunteers occur between 1 and 2 hours with a terminal plasma elimination half-life of approximately 30 hours (range: 20 to 50 hours) after oral administration. In fasted normal volunteers, administration of a single oral 400 mg dose of fluconazole leads to a mean C max of 6.72 mcg/mL (range: 4.12 to 8.08 mcg/mL) and after single or multiple oral doses of 50 to 400 mg, fluconazole plasma concentrations and area under the plasma concentration time curve (AUC) are dose proportional (Table 1).
The C max and AUC data from a food-effect study involving administration of fluconazole tablets to healthy volunteers under fasting conditions and with a high-fat meal indicated that exposure to the drug is not affected by food. Therefore, fluconazole may be taken without regard to meals (see DOSAGE AND ADMINISTRATION ). Table 1: Mean Pharmacokinetic Parameters of Fluconazole in Adult Healthy Volunteers Following the Administration of Fluconazole Tablets Dose regimen C max (mcg/mL) AUC 0-24 (mcg*h/mL) Half-life (hours) 50 mg oral (once daily x 7 days) 2.21 37.6 26.6 100 mg oral (once daily x 7 days) 4.81 82.5 27.7 150 mg single oral 2.70 137* 34.1 200 mg oral (once daily x 14 days) 10.12 169.5 31 300 mg oral (once daily x 14 days) 15.98 299.4 34 400 mg oral (once daily x 14 days) 18.89 349.9 31 *AUC 0-inf.
C max = peak plasma concentrations, AUC =area under the plasma concentration time curve. Steady-state concentrations are reached within 5 to 10 days following oral doses of 50 to 400 mg given once daily. Administration of a loading dose (on Day 1) of twice the usual daily dose results in plasma concentrations close to steady-state by the second day.
The apparent volume of distribution of fluconazole approximates that of total body water. Plasma protein binding is low (11 to 12%). Following either single- or multiple oral doses for up to 14 days, fluconazole penetrates into all body fluids studied (see table below).
In normal volunteers, saliva concentrations of fluconazole were equal to or slightly greater than plasma concentrations regardless of dose, route, or duration of dosing. In patients with bronchiectasis, sputum concentrations of fluconazole following a single 150 mg oral dose were equal to plasma concentrations at both 4 and 24 hours post dose. In patients with fungal meningitis, fluconazole concentrations in the cerebrospinal fluid (CSF) are approximately 80% of the corresponding plasma concentrations.
A single oral 150 mg dose of fluconazole administered to 27 patients penetrated into vaginal tissue, resulting in tissue: plasma ratios ranging from 0.94 to 1.14 over the first 48 hours following dosing. A single oral 150 mg dose of fluconazole administered to 14 patients penetrated into vaginal fluid, resulting in fluid: plasma ratios ranging from 0.36 to 0.71 over the first 72 hours following dosing. Table 2: Ratio of Fluconazole Tissue (Fluid)/Plasma Concentration Tissue or Fluid Ratio of Fluconazole Tissue (Fluid)/Plasma Concentration * Cerebrospinal fluid † 0.5 to
0.9Saliva 1 Sputum 1 Blister fluid 1 Urine 10 Normal skin 10 Nails 1 Blister skin 2 Vaginal tissue 1 Vaginal fluid 0.4 to 0.7 * Relative to concurrent concentrations in plasma in subjects with normal renal function. † Independent of degree of meningeal inflammation. Mean body clearance in adults is reported to be 0.23 (17%) mL/min/kg. In normal volunteers, fluconazole is cleared primarily by renal excretion, with approximately 80% of the administered dose appearing in the urine as u… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
Mechanism of Action Fluconazole is a highly selective inhibitor of fungal cytochrome P450 dependent enzyme lanosterol 14-α-demethylase. This enzyme functions to convert lanosterol to ergosterol. The subsequent loss of normal sterols correlates with the accumulation of 14-α-methyl sterols in fungi and may be responsible for the fungistatic activity of fluconazole. Mammalian cell demethylation is much less sensitive to fluconazole inhibition.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Fluconazole Tablets, USP 50 mg are pink, trapezoidal shaped tablets, engraved with “50” on one side and plain on the other side, supplied as follows: NDC 68462-101-30 Bottles of 30 NDC 68462-101-10 Bottles of 1000 Fluconazole Tablets, USP 100 mg are pink, trapezoidal shaped tablets, engraved with “100” on one side and plain on the other side, supplied as follows: NDC 68462-102-30 Bottles of 30 NDC 68462-102-10 Bottles of 1000 Fluconazole Tablets, USP 150 mg are pink, oval shaped tablets, engraved with “150” on one side and plain on the other side, supplied as follows: NDC 68462-103-40 Blister Card of 1 Tablet NDC 68462-103-40 Carton of 12 Unit-Dose Tablets NDC 68462-119-40 Blister Pack of 1 Tablet NDC 68462-119-40 Carton of 1 Unit-Dose Tablet NDC 68462-119-44 Carton of 12 Unit-Dose Tablets Fluconazole Tablets, USP 200 mg are pink trapezoidal shaped tablets, engraved with “200” on one side and plain on the other side, supplied as follows: NDC 68462-104-30 Bottles of 30 NDC 68462-104-10 Bottles of 1000 Storage: Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].
Distributed by: Glenmark Pharmaceuticals Inc., USA Elmwood Park, NJ 07407 Questions? 1 (888) 721-7115 www.glenmarkpharma-us.com June 2025 logo
📋 Description ▾
DESCRIPTION Fluconazole, USP the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole, USP is designated chemically as 2,4-difluoro-1 ’ ,1 ’ -bis(1 H -1,2,4-triazol-1-ylmethyl)benzyl alcohol with an empirical formula of C 13 H 12 F 2 N 6 O and molecular weight of 306.27. The structural formula is: Fluconazole, USP is a white or almost white crystalline powder which is freely soluble in methanol; soluble in alcohol and in acetone; sparingly soluble in isopropanol and in chloroform; slightly soluble in water; very slightly soluble in toluene.
Fluconazole Tablets, USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole, USP and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, FD&C Red No. 40, magnesium stearate, microcrystalline cellulose and povidone K-30. structure
⚠️ Precautions ▾
PRECAUTIONS General Some azoles, including fluconazole, have been associated with prolongation of the QT interval on the electrocardiogram. Fluconazole causes QT prolongation via the inhibition of Rectifier Potassium Channel current (Ikr). The QT prolongation caused by other medicinal products (such as amiodarone) may be amplified via the inhibition of cytochrome P450 (CYP) 3A4 (see PRECAUTIONS: Drug Interactions ).
During post-marketing surveillance, there have been rare cases of QT prolongation and torsade de pointes in patients taking fluconazole. Most of these reports involved seriously ill patients with multiple confounding risk factors, such as structural heart disease, electrolyte abnormalities, and concomitant medications that may have been contributory. Patients with hypokalemia and advanced cardiac failure are at an increased risk for the occurrence of life-threatening ventricular arrhythmias and torsade de pointes.
Fluconazole should be administered with caution to patients with these potentially proarrhythmic conditions. Concomitant use of fluconazole and erythromycin has the potential to increase the risk of cardiotoxicity (prolonged QT interval, torsade de pointes) and consequently sudden heart death. This combination should be avoided.
Fluconazole should be administered with caution to patients with renal dysfunction. Adrenal insufficiency has been reported in patients receiving azoles, including fluconazole. Reversible cases of adrenal insufficiency have been reported in patients receiving fluconazole.
When driving vehicles or operating machines, it should be taken into account that occasionally dizziness or seizures may occur. There have been reports of cases of superinfection with Candida species other than C. albicans , which are often inherently not susceptible to fluconazole tablets (e.g., Candida krusei ). Such cases may require alternative antifungal therapy (see CLINICAL PHARMACOLOGY, Microbiology ).
Single Dose The convenience and efficacy of the single dose oral tablet of fluconazole regimen for the treatment of vaginal yeast infections should be weighed against the acceptability of a higher incidence of drug related adverse events with fluconazole (26%) versus intravaginal agents (16%) in U.S. comparative clinical studies (see ADVERSE REACTIONS and CLINICAL STUDIES ). Drug Interactions: (See CONTRAINDICATIONS ) Fluconazole is a moderate CYP2C9 and CYP3A4 inhibitor. Fluconazole is also a strong inhibitor of CYP2C19.
Patients treated with fluconazole, who are also concomitantly treated with drugs with a narrow therapeutic window metabolized through CYP2C9 and CYP3A4, should be monitored for adverse reactions associated with the concomitantly administered drugs. In addition to the observed/documented interactions mentioned below, there is a risk of increased plasma concentration of other compounds metabolized by CYP2C9, CYP2C19, and CYP3A4 coadministered with fluconazole. Therefore, caution should be exercised when using these combinations and the patients should be carefully monitored.
The enzyme inhibiting effect of fluconazole persists 4 to 5 days after discontinuation of fluconazole treatment due to the long half-life of fluconazole. Clinically or potentially significant drug interactions between fluconazole and the following agents/classes have been observed and are described in greater detail below: Abrocitinib: Drug interaction studies indicate that when co-administered with fluconazole (strong inhibitor of CYP2C19; moderate inhibitor of CYP2C9 and CYP3A4), the systemic exposure of abrocitinib and its active metabolites increased (see CLINICAL PHARMACOLOGY ).
Avoid concomitant use of abrocitinib with fluconazole. Refer to the abrocitinib Prescribing Information for additional details. Alfentanil : A study observed a reduction in clearance and distribution volume as well as prolongation of t ½ of alfentanil following concomitant treatment with fluconazole.
A possible mechanism of action is flucona… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
Nursing Mothers Fluconazole was present in low levels in breast milk following administration of a single 150 mg dose, based on data from a study in 10 breastfeeding women who temporarily or permanently discontinued breastfeeding 5 days to 19 months postpartum. The estimated daily infant dose of fluconazole from breast milk (assuming mean milk consumption of 150 mL/kg/day) based on the mean peak milk concentration (2.61 mcg/mL [range: 1.57 to 3.65 mcg/mL] at 5.2 hours post-dose) was 0.39 mg/kg/day, which is approximately 13% of the recommended pediatric dose for oropharyngeal candidiasis.
(Labeled pediatric dose is 6 mg/kg/day on the first day followed by 3 mg/kg/day; estimated infant dose is 13% of 3 mg/kg/day maintenance dose). There are no data on fluconazole levels in milk after repeated use or after high-dose fluconazole. A published survey of 96 breastfeeding women who were treated with fluconazole 150 mg every other day (average of 7.3 capsules [range 1 to 29 capsules]) for lactation-associated candida of the breasts reported no serious adverse reactions in infants.
Caution should be exercised when fluconazole is administered to a nursing woman.
🔬 Clinical Studies ▾
CLINICAL STUDIES Cryptococcal meningitis: In a multicenter study comparing fluconazole (200 mg/day) to amphotericin B (0.3 mg/kg/day) for treatment of cryptococcal meningitis in patients with AIDS, a multivariate analysis revealed three pretreatment factors that predicted death during the course of therapy: abnormal mental status, cerebrospinal fluid cryptococcal antigen titer greater than 1:1024, and cerebrospinal fluid white blood cell count of less than 20 cells/mm 3 . Mortality among high risk patients was 33% and 40% for amphotericin B and fluconazole patients, respectively (p=0.58), with overall deaths 14% (9 of 63 subjects) and 18% (24 of 131 subjects) for the 2 arms of the study (p=0.48).
Optimal doses and regimens for patients with acute cryptococcal meningitis and at high risk for treatment failure remain to be determined. (Saag, et al. N Engl JMed 1992; 326:83-9.) Vaginal candidiasis: Two adequate and well-controlled studies were conducted in the U.S. using the 150 mg tablet.
In both, the results of the fluconazole regimen were comparable to the control regimen (clotrimazole or miconazole intravaginally for 7 days) both clinically and statistically at the one month post-treatment evaluation. The therapeutic cure rate, defined as a complete resolution of signs and symptoms of vaginal candidiasis (clinical cure), along with a negative KOH examination and negative culture for Candida (microbiologic eradication), was 55% in both the fluconazole group and the vaginal products group. Fluconazole PO 150 mg tablet Vaginal Product qhs x 7 days Enrolled 448 422 Evaluable at Late Follow-up 347 (77%) 327 (77%) Clinical cure 239/347 (69%) 235/327 (72%) Mycologic eradication 213/347 (61%) 196/327 (60%) Therapeutic cure 190/347 (55%) 179/327 (55%) Approximately three-fourths of the enrolled patients had acute vaginitis (<4 episodes/12 months) and achieved 80% clinical cure, 67% mycologic eradication, and 59% therapeutic cure when treated with a 150 mg fluconazole tablet administered orally.
These rates were comparable to control products. The remaining one-fourth of enrolled patients had recurrent vaginitis (≥4 episodes/12 months) and achieved 57% clinical cure, 47% mycologic eradication, and 40% therapeutic cure. The numbers are too small to make meaningful clinical or statistical comparisons with vaginal products in the treatment of patients with recurrent vaginitis.
Substantially more gastrointestinal events were reported in the fluconazole group compared to the vaginal product group. Most of the events were mild to moderate. Because fluconazole was given as a single dose, no discontinuations occurred.
Parameter Fluconazole PO Vaginal Products Evaluable patients 448 422 With any adverse event 141 (31%) 112 (27%) Nervous System 90 (20%) 69 (16%) Gastrointestinal 73 (16%) 18 (4%) With drug-related event 117 (26%) 67 (16%) Nervous System 61 (14%) 29 (7%) Headache 58 (13%) 28 (7%) Gastrointestinal 68 (15%) 13 (3%) Abdominal pain 25 (6%) 7 (2%) Nausea 30 (7%) 3 (1%) Diarrhea 12 (3%) 2 (<1%) Application site event 0 (0%) 19 (5%) Taste Perversion 6 (1%) 0 (0%) Pediatric Studies Oropharyngeal candidiasis: An open-label, comparative study of the efficacy and safety of fluconazole (2 to 3 mg/kg/day) and oral nystatin (400,000 I.U.
4 times daily) was conducted in immunocompromised pediatric patients from 6 months to 13 years of age with oropharyngeal candidiasis. Clinical and mycological response rates were higher in pediatric patients treated with fluconazole. Clinical cure at the end of treatment was reported for 86% of fluconazole-treated patients compared to 46% of nystatin treated patients.
Mycologically, 76% of fluconazole treated patients had the infecting organism eradicated compared to 11% for nystatin treated patients. Fluconazole Nystatin Enrolled 96 90 Clinical Cure 76/88 (86%) 36/78 (46%) Mycological eradication * 55/72 (76%) 6/54 (11%) * Subjects without follow-up cultures for any reason were considered nonevaluable for myco… [Excerpted — this section continues on DailyMed.]
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis, and Impairment of Fertility Fluconazole showed no evidence of carcinogenic potential in mice and rats treated orally for 24 months at doses of 2.5 mg/kg/day, 5 mg/kg/day, or 10 mg/kg/day (approximately 2 to 7 times the recommended human dose). Male rats treated with 5 mg/kg/day and 10 mg/kg/day had an increased incidence of hepatocellular adenomas. Fluconazole, with or without metabolic activation, was negative in tests for mutagenicity in four strains of S. typhimurium , and in the mouse lymphoma L5178Y system.
Cytogenetic studies in vivo (murine bone marrow cells, following oral administration of fluconazole) and in vitro (human lymphocytes exposed to fluconazole at 1000 mcg/mL) showed no evidence of chromosomal mutations. Fluconazole did not affect the fertility of male or female rats treated orally with daily doses of 5 mg/kg, 10 mg/kg, or 20 mg/kg or with parenteral doses of 5 mg/kg, 25 mg/kg, or 75 mg/kg, although the onset of parturition was slightly delayed at 20 mg/kg PO. In an intravenous perinatal study in rats at 5 mg/kg, 20 mg/kg, and 40 mg/kg, dystocia and prolongation of parturition were observed in a few dams at 20 mg/kg (approximately 5 to 15 times the recommended human dose) and 40 mg/kg, but not at 5 mg/kg.
The disturbances in parturition were reflected by a slight increase in the number of still born pups and decrease of neonatal survival at these dose levels. The effects on parturition in rats are consistent with the species specific estrogen-lowering property produced by high doses of fluconazole. Such a hormone change has not been observed in women treated with fluconazole (see CLINICAL PHARMACOLOGY ).
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL NDC 68462-101-30 Fluconazole tablets, USP 50 mg Bottle Label label50mg30
PRINCIPAL DISPLAY PANEL NDC 68462-102-30 Fluconazole tablets, USP 100 mg Bottle Label label100mg30
PRINCIPAL DISPLAY PANEL NDC 68462-104-30 Fluconazole tablets, USP 200 mg Bottle Label label200mg30
PRINCIPAL DISPLAY PANEL NDC68426-119-40 Fluconazole tablets, USP 150 mg Carton 1 x 1 ctn150mg
PRINCIPAL DISPLAY PANEL NDC68426-119-44 Fluconazole tablets, USP 150 mg Carton 12 x 1 carton150mg