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Fluconazole 200 mg Tablet, 3-count — NDC 72189-516-03 (Billing 72189-0516-03)

by Direct_Rx · 3 TABLET in 1 BOTTLE

This is a package of 3 tablets of Fluconazole 200 mg Tablet from Direct_Rx, marketed since Oct 2023 and currently FDA-listed. It is this product's only package size.

NDC 72189-0516-03
🏷️ FDA NDC (as labeled) 72189-516-03 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72189-516-03
Product NDC 72189-516
11-digit billing NDC 72189051603
NCPDP billing unit EA — each (per item)
RxCUI 197700
UNII 8VZV102JFY
Application # ANDA077731
SPL Set ID 06f8f4b9-5289-2d59-e063-6294a90a7209
Established class (EPC) Azole Antifungal
Mechanism of action Cytochrome P450 2C19 Inhibitors; Cytochrome P450 3A4 Inhibitors; Cytochrome P450 2C9 Inhibitors
Chemical class Azoles
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-10-05
Route ORAL
Dosage form TABLET
Substance FLUCONAZOLE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 013724
GCN 42191
HICL code 004868
Ingredient (HICL) Fluconazole
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W3
Therapeutic class — intermediate (HIC2) Antimycotics
HIC3 code W3B
Therapeutic class — specific (HIC3) Antifungal Agents
AHFS code 08:14.08.00
AHFS class Azole Antifungals
FDB label name FLUCONAZOLE 200 MG TABLET
FDB brand name Fluconazole
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 013724
  • GCN: 42191
  • HICL (First Databank): 004868
  • AHFS class code: 08:14.08.00
  • RxCUI (RxNorm): 197700
Why two NDCs? The FDA registers this code as 72189-516-03 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 72189-0516-03. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Azole Antifungal class.

Pharmacologic class Azole Antifungal
Drug family (ATC) Imidazole and triazole derivatives, Triazole and tetrazole derivatives
How it works Cytochrome P450 2C19 Inhibitors, Cytochrome P450 3A4 Inhibitors, Cytochrome P450 2C9 Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name FLUCONAZOLE 200 MG TABLET Ingredient Fluconazole
📖 What it is MedlinePlus · NLM

Fluconazole is used to treat fungal infections, including yeast infections of the vagina, mouth, throat, esophagus (tube leading from the mouth to the stomach), abdomen (area between the chest and waist), lungs, blood, and other organs. Fluconazole is also used to treat meningitis (infection of the membranes covering the brain and spine) caused by fungus. Fluconazole is also used to prevent yeast infections in patients who are likely to become infected because they are being treated with chemotherapy or radiation therapy before a bone marrow transplant (replacement of unhealthy spongy tissue i...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • 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...
📖 Read our full Fluconazole guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.4361 $1.31 / 3 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
72189-0516-03 You're viewing this Main listing 3 TABLET in 1 BOTTLE 2023-10-05 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Fluconazole 200 mg 00904-6501-06 Major 50 tablets $0.380 AB Availability likely —
Fluconazole 200 mg 16714-0693-01 NorthStar 30 tablets $0.380 AB Availability likely —
Fluconazole 200 mg 50268-0339-15 AvPAK 50 tablets $0.380 AB Availability likely —
Fluconazole 200 mg 55111-0146-01 Dr. 100 tablets $0.380 AB Availability likely —
Fluconazole 200 mg 57237-0006-01 Rising 100 tablets $0.380 AB Availability likely —
Fluconazole 200 mg 62135-0133-30 Chartwell 30 tablets $0.380 AB Availability likely —
Fluconazole 200 mg 62559-0993-30 ANI 30 tablets $0.380 AB Availability likely —
Fluconazole 200 mg 68001-0254-04 BluePoint 30 tablets $0.380 AB Availability likely —
Fluconazole 200 mg 68084-0735-01 American 100 tablets $0.380 AB Availability likely —
fluconazole 200 mg 70710-1140-01 Zydus 100 tablets $0.380 AB Availability likely —
fluconazole 200 mg 50090-4864-01 A-S 30 tablets — AB FDA listed —
Fluconazole 200 mg 50090-6751-00 A-S 28 tablets — AB FDA listed —
Fluconazole 200 mg 51407-0427-01 Golden 100 tablets — AB FDA listed —
Fluconazole 200 mg 55154-7875-00 Cardinal 10 tablets — AB FDA listed —
Fluconazole 200 mg 55289-0824-20 PD-Rx 20 tablets — AB FDA listed —
Fluconazole 200 mg 61919-0493-03 Direct 3 tablets — AB FDA listed —
Fluconazole 200 mg 63187-0878-01 Proficient 1 tablet — AB FDA listed —
Fluconazole 200 mg 63629-9091-01 Bryant 30 tablets — AB FDA listed —
Fluconazole 200 mg 65862-0061-01 Aurobindo 100 tablets — AB FDA listed —
Fluconazole 200 mg 68071-3428-02 NuCare 2 tablets — AB FDA listed —
Fluconazole 200 mg 68071-3547-03 NuCare 30 tablets — AB FDA listed —
Fluconazole 200 mg 68462-0104-10 Glenmark 1000 tablets — AB FDA listed —
Fluconazole 200 mg 68788-8526-00 Preferred 1 tablet — AB FDA listed —
Fluconazole 200 mg 70518-4020-00 REMEDYREPACK 30 tablets — AB FDA listed —
fluconazole 200 mg 70771-1066-01 Zydus 100 tablets — AB FDA listed —
fluconazole 200 mg 71205-0283-30 Proficient 30 tablets — AB FDA listed —
fluconazole 200 mg 71335-0769-00 Bryant 4 tablets — AB FDA listed —
Fluconazole 200 mg 71335-1895-00 Bryant 4 tablets — AB FDA listed —
Fluconazole 200 mg 71335-2235-00 Bryant 4 tablets — AB FDA listed —
Fluconazole 200 mgthis 72189-0516-03 Direct_Rx 3 tablets — AB FDA listed —
Fluconazole 200 mg 77771-0399-01 Radha 100 tablets — AB FDA listed —
Fluconazole 200 mg 82804-0030-30 Proficient 30 tablets — AB FDA listed —
Fluconazole 200 mg 82804-0146-06 Proficient 6 tablets — AB FDA listed —
Fluconazole 200 mg 85766-0104-00 Sportpharm 100 tablets — AB FDA listed —
Fluconazole 200 mg 85766-0159-00 Sportpharm 100 tablets — AB FDA listed —
Fluconazole 200 mg 87063-0206-00 ASCLEMED 100 tablets — AB FDA listed —
fluconazole 200 mg 68788-4163-00 Preferred 1 tablet — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2023
On the market since
Oct 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color pink
ShapeCapsule
ImprintC;07
Size14 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII L11K75P92J
    A mineral salt made from calcium and phosphate. It acts as a filler and binder in tablets to add bulk and help hold the medicine together in solid form.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.

6 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerDirect_Rx
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA077731 (ANDA)
Labeler code72189
First marketedOct 2023
Product typeHuman Prescription Drug
Portfolio355 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Patient Medication Information ⚠️ Precautions 🔬 Clinical Studies 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 162 words ▾

Fluconazole tablets are indicated for the treatment of: Vaginal candidiasis (vaginal yeast infections due to Candida). 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.

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 ~3 min read ▾

Dosage and Administration in Adults: Single Dose Vaginal candidiasis: The recommended dosage of fluconazole tablets 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 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 tablets 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 tablets 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 tablets 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 tablets 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 tablets 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/mm3) should start fluconazole tablets prophylaxis several days before the anticipated onset of neutropenia, and continue for 7 days after the neutrophil count rises above 1000 cells/mm3.

Dosage and Administration in Children: The following dose equivalency scheme should generally provide equivalent exposure in pediatric and adult patients: Pediatric Patients Adults * Some older children may have clearances similar to that of adults. Absolute doses exceeding 600 mg/day are not recommended. 3 mg/kg 100 mg 6 mg/kg 200 mg 12* mg/kg 400 mg Experience with fluconazole in neonates is limited to pharmacokinetic studies in premature newborns.

(See CLINICAL PHARMACOLOGY.) Based on the prolonged half-life seen in premature newborns (gestational age 26 to 29 weeks), these children, in the first two weeks of life, shoul… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications 84 words ▾

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 tablets 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 ~2 min read ▾

(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 ~3 min read ▾

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 occurred during po… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 87 words ▾

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 ~3 min read ▾

Pharmacokinetics and Metabolism The pharmacokinetic properties 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 (Cmax) 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 Cmax of 6.72 mcg/mL (range: 4.12 to 8.08 mcg/mL) and after single oral doses of 50 to 400 mg, fluconazole plasma concentrations and area under the plasma concentration-time curve (AUC) are dose proportional.

The Cmax 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.) 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. * Relative to concurrent concentrations in plasma in subjects with normal renal function. † Independent of degree of meningeal inflammation.

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

0.7In normal volunteers, fluconazole is cleared primarily by renal excretion, with approximately 80% of the administered dose appearing in the urine as unchanged drug. About 11% of the dose is excreted in the urine as metabolites. The pharmacokinetics of fluconazole are markedly affected by reduction in renal function.

There is an inverse relationship between the elimination half-life and creatinine clearance. The dose of fluconazole may need to be reduced in patients with impaired renal function. (See DOSAGE AND ADMINISTRATION.) A 3-hour hemodialysis session decreases plasma concentrations by approximately 50%.

In normal volunteers, fluconazole administration (doses ranging from 200 mg to 400 mg once daily for up to 14 days) was associated with small and inconsistent effects on testosterone concentrations, endogenous corticosteroid concentrations, and the adrenocorticotropic hormone (ACTH)-stimulated cortisol resp… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 122 words ▾

Fluconazole Tablets USP, 50 mg are pink mottled, biconvex, capsule shaped uncoated tablets with “C” debossed on one side and “04” debossed on other side. Bottles of 30 NDC 57237-003-30 Fluconazole Tablets USP, 100 mg are pink mottled, biconvex, capsule shaped uncoated tablets with “C” debossed on one side and “05” debossed on other side. Bottles of 30 NDC 57237-004-30 Fluconazole Tablets USP, 150 mg are pink mottled, biconvex, capsule shaped uncoated tablets with “C” debossed on one side and “10” debossed on other side.

Unit dose package of 1 NDC 57237-005-11 Fluconazole Tablets USP, 200 mg are pink mottled, biconvex, capsule shaped uncoated tablets with “C” debossed on one side and “07” debossed on other side. Bottles of 3 NDC 72189-516-03

📦 Storage and Handling 67 words ▾

Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Maalox® is a registered trademark of Novartis Consumer Health, Inc. XELJANZ® is a registered trademark of Pfizer, Inc. LYNPARZA® is a registered trademark of AstraZeneca group of companies. Distributed by: Rising Health, LLC East Brunswick, NJ 08816 Made in India Code: TS/DRUGS/19/1993 Revised: 09/2023

📋 Description 104 words ▾

Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with a molecular formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is: [Chemical Structure] Fluconazole USP is a white crystalline solid which is slightly soluble in water and saline.

Fluconazole tablets USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole USP and the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, povidone, croscarmellose sodium, FD&C Red No. 40 aluminum lake dye, and magnesium stearate. Meets USP Dissolution Test 2.

💬 Patient Medication Information ~3 min read ▾

PATIENT INFORMATION Fluconazole (floo kon' a zole) Tablets This leaflet contains important information about fluconazole tablets. It is not meant to take the place of your healthcare provider’s instructions. Read this information carefully before you take fluconazole tablets.

Ask your healthcare provider if you do not understand any of this information or if you want to know more about fluconazole tablets. What are fluconazole tablets? Fluconazole tablets are a prescription medicine used to treat vaginal yeast infections caused by a yeast called Candida.

Fluconazole tablet helps stop too much yeast from growing in the vagina so the yeast infection goes away. Fluconazole tablets are different from other treatments for vaginal yeast infections because it is a tablet taken by mouth. Fluconazole tablets are also used for other conditions.

However, this leaflet is only about using fluconazole tablets for vaginal yeast infections. For information about using fluconazole tablets for other reasons, ask your healthcare provider. See the section of this leaflet for information about vaginal yeast infections.

What is a vaginal yeast infection? It is normal for a certain amount of yeast to be found in the vagina. Sometimes too much yeast starts to grow in the vagina and this can cause a yeast infection.

Vaginal yeast infections are common. About three out of every four adult women will have at least one vaginal yeast infection during their life. Some medicines and medical conditions can increase your chance of getting a yeast infection.

If you are pregnant, have diabetes, use birth control pills, or take antibiotics you may get yeast infections more often than other women. Personal hygiene and certain types of clothing may increase your chances of getting a yeast infection. Ask your healthcare provider for tips on what you can do to help prevent vaginal yeast infections.

If you get a vaginal yeast infection, you may have any of the following symptoms: itching a burning feeling when you urinate redness soreness a thick white vaginal discharge that looks like cottage cheese Do not take fluconazole tablets if you. take the following medicines: quinidine erythromycin pimozide are allergic to fluconazole, the active ingredient in fluconazole tablets, or any of the ingredients in fluconazole tablets. See the end of this Patient Information leaflet for a complete list of ingredients in fluconazole tablets.

Before you take fluconazole tablets, tell your healthcare provider about all of your medical conditions, if you: have liver problems have kidney problems have heart problems including heart arrythmias have hypokalemia (low potassium) are pregnant or plan to become pregnant. Tell your healthcare provider right away if you become pregnant while taking fluconazole tablets. You and your healthcare provider will decide if fluconazole tablets are right for you.

If you may become pregnant you should use a birth-control (contraceptive) method while taking fluconazole tablets and for 1 week after your final dose. are breastfeeding or plan to breastfeed. Fluconazole can pass into your breastmilk. Talk to your healthcare provider about the best way to feed your baby while you are taking fluconazole tablets.

Before you start taking fluconazole tablets, tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take: diabetes medicines such as glyburide, tolbutamide, glipizide blood pressure medicines like hydrochlorothiazide, losartan, amlodipine, verapamil, nifedipine or felodipine blood thinners such as warfarin cyclosporine, tacrolimus or sirolimus (used to prevent rejection of organ transplants) rifampin or rifabutin for tuberculosis phenytoin or carbamazepine to control seizures theophylline to control asthma quinidine (used to correct disturbances in heart rhythm) amiodarone (used for treating uneven heartbeat… [Excerpted — this section continues on DailyMed.]

⚠️ Precautions ~2 min read ▾

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. 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 coadministered 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 t½ of alfentanil following concomitant treatment with fluconazole.

A possible mechanism of action is fluconazole’s inhibition of CYP3A4. Dosage adjustment of alfentanil may be necessary. Amiodarone: Concomitant administration of fluconazole with amiodarone may increase QT prolongation.

Caution must be exercised if the concomitant use of fluconazole and amiodarone is necessary, notably with high-dose fluco… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

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/mm3. 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 J Med 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) in immunocompromised children with oropharyngeal candidiasis was conducted. Clinical and mycological response rates were higher in the children 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 * Subjects without follow-up cultures for any reason were considered nonevaluable for mycological response. Enrolled 96 90 Clinical Cure 76/88 (86%) 36/78 (46%) Mycological eradication* 55/72 (76%) 6/54 (11%) The proportion of patients with clinical relapse 2… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 1 words ▾

72189-516-03

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Fluconazole — the program that covers self-administered drugs. 14 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Fluconazole. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$8.38M
Claims incl. refills
954.9K
Beneficiaries
747.5K
Spend / beneficiary
$11.21
Spend / claim
$8.78
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
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