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FLUCONAZOLE 150 mg Tablet, 1 tablet — NDC 72189-0342-01 package photo

FLUCONAZOLE 150 mg Tablet, 1 tablet

by Direct Rx · 1 TABLET in 1 BOTTLE (72189-342-01)
NDC 72189-0342-01
🏷️ FDA NDC (as labeled) 72189-342-01 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

🆔 Identity & classification

FDA NDC (as labeled) 72189-342-01
Product NDC 72189-342
11-digit billing NDC 72189034201
NCPDP billing unit EA — each (per item)
RxCUI 197699
UNII 8VZV102JFY
Application # ANDA077253
SPL Set ID db886cfe-ea23-50c9-e053-2995a90a4d10
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 2022-03-31
Route ORAL
Dosage form TABLET
Substance FLUCONAZOLE
GPI-14 11407015000325
GPI class Fluconazole
GCN Seq No 022141
GCN 42193
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 150 MG TABLET
FDB brand name Fluconazole
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 72189-342-01 — 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 → 72189-0342-01. 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.

🏭 Manufacturer & labeler

LabelerDirect Rx
Application holderGLENMARK PHARMACEUTICALS LTD
FDA applicationANDA077253 (ANDA)
Labeler code72189
First marketedMar 2022
Product typeHuman Prescription Drug
Portfolio204 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.

🩺 Clinical

Label name FLUCONAZOLE 150 MG TABLET Ingredient Fluconazole
📗 Our plain-language guide HelloPharmacist
  • Fluconazole is an antifungal — it fights infections caused by yeasts and fungi, not bacteria. It's most commonly used for vaginal yeast infections (a single pill often does the job...
  • Yes — you can take the tablet or liquid suspension with or without food, whichever is easier for you. Food doesn't change how well the body absorbs it, so there's no need to time i...
  • The most common side effects are pretty mild — nausea, headache, stomach pain, and sometimes diarrhea or dizziness. Most people tolerate it fine. The ones to call your doctor about...
  • What side effects should I expect, and which ones mean I should call my doctor?
📖 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.

🧪 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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.

💲 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 $0.44 / 1 tablet
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Fluconazole 150 mg 16714-0692-11 NorthStar 12 tablets $0.433 AB Availability likely —
Fluconazole 150 mg 55111-0145-12 Dr. 12 tablets $0.433 AB Availability likely —
Fluconazole 150 mg 57237-0005-11 Rising 12 tablets $0.433 AB Availability likely —
Fluconazole 150 mg 62135-0132-77 Chartwell 1 tablet $0.433 AB Availability likely —
Fluconazole 150 mg 62559-0992-12 ANI 12 tablets $0.433 AB Availability likely —
Fluconazole 150 mg 68001-0253-17 BluePoint 12 tablets $0.433 AB Availability likely —
Fluconazole 150 mg 68462-0119-40 Glenmark 1 tablet $0.433 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 mgthis 72189-0342-01 Direct 1 tablet — AB FDA listed —
Fluconazole 150 mg 72789-0209-02 PD-Rx 2 tablets — AB FDA listed —
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 —
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

🏛️
2022
On the market since
Mar 2022
📍
2026
Currently FDA-listed
4 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.

📊 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Fluconazole — the ingredient across all brands.

Top reported reactions

Pyrexia4,205
Nausea3,813
Diarrhoea3,614
Fatigue3,266
Pain3,181
Drug Interaction3,040
Headache2,930

Reporter sex

0 reports

Serious outcomes

Death12,477
Life-threatening6,371
Disabling1,914
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 5,586 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
72189-0342-01 You're viewing this 1 TABLET in 1 BOTTLE (72189-342-01) 2022-03-31 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

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.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 72189-342-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 72189-0342-01, written without dashes as 72189034201. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 72189-0342-01, the first segment (72189) is the labeler code FDA assigned to Direct Rx; the middle segment (0342) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Direct Rx. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Direct Rx is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. 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 📋 Description 💬 Patient Medication Information
🎯 Indications and Usage 165 words ▾

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 ~3 min read ▾

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/mm3) 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/mm3.

Dosage and Administration in Children: The following dose equivalency scheme should generally provide equivalent exposure in pediatric and adult patients: Pediatric Patients Adults 3 mg/kg 100 mg 6 mg/kg 200 mg 12* mg/kg 400 mg * Some older children may have clearances similar to that of adults. Absolute doses exceeding 600 mg/day are not recommended. 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, should receive the same dosage (mg/kg) as in older chi…

⛔ Contraindications 80 words ▾

Fluconazole is 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 STUDIESandPRECAUTIONS).

⚠️ 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 pos…

🆘 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.

Tissue or Fluid Ratio of FluconazoleTissue (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. In 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 respons…

📦 How Supplied / Storage and Handling 172 words ▾

Fluconazole Tablets, USP: Pink trapezoidal tablets containing 50, 100, or 200 mg of fluconazole, USP are packaged in bottles. Fluconazole Tablets, USP 150 mg are pink, oval shaped, packaged in a blister pack of 1 tablet. Fluconazole Tablets, USP are supplied as follows: Fluconazole Tablets, USP 50 mg: Engraved with “50” on one side and plain on the other side.

Bottles of 30 Fluconazole Tablets, USP 100 mg: Engraved with “100” on one side and plain on the other side. Bottles of 30 Fluconazole Tablets, USP 150 mg: Engraved with “150” on one side and plain on the other side. Carton of 1 blister pack of 1 tablet (1 x 1 unit-dose) Fluconazole Tablets, USP 200 mg: Engraved with “200” on one side and plain on the other side.

Bottles of 30 Storage: Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India Manufactured for: Logo.jpg Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 (888) 721-7115 www.glenmarkpharma-us.com November 2021

📋 Description 121 words ▾

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(1H-1,2,4-triazol-1-ylmethyl)benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.27 g/mol. The structural formula is: structure 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.

💬 Patient Medication Information ~3 min read ▾

PATIENT INFORMATION FLUCONAZOLE (floo-KON-a-zole) TABLETS This leaflet contains important information about fluconazole. 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 tablets helps stop too much yeast from growing in the vagina so the yeast infection goes away. Fluconazole tablets is different from other treatments for vaginal yeast infections because it is a tablet taken by mouth. Fluconazole tablets is 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: Do not take Fluconazole Tablets if you. • take the following medicines: o quinidine o erythromycin o pimozide o 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 is 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 heartbeats ‘arrhythmias’) • amitriptyline or nortriptyline for depression • pimozide for psychiatric ill…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 72189-0341-09 · Direct 72189-0343-08 · Direct →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.