Flucytosine 500 mg Capsule, 30-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Nucleoside Analog Antifungal class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
- That's a great question. Flucytosine can work alone against some fungi, but the problem is that the fungus can develop resistance to it pretty quickly when it's used by itself. Pai...
- Why do I have to take flucytosine with another antifungal? Can't it work on its own?
- Yes — and this is one of the most practical tips for taking this medication. Instead of swallowing all your capsules at once, try taking a few at a time over about 15 minutes. Spre...
- The capsules are making me feel sick to my stomach. Is there anything I can do?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Flucytosine — tap one for details:
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Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 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.
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UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
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UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII WZH3C48M4T
Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII 46N107B71O
Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
9 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
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?
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💲 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 each | Per 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 | $31.31 | $939.35 / 30 capsules |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Ancobon 500 mg 00187-3555-10 | Bausch | 100 capsules | — | AB | FDA listed | — |
| Flucytosine 500 mg 00904-6835-07 | Major | 30 capsules | — | AB | FDA listed | — |
| Flucytosine 500 mgthis 23155-0861-03 | Heritage | 30 capsules | — | AB | FDA listed | — |
| Flucytosine 500 mg 40032-0770-01 | Novel | 100 capsules | — | AB | FDA listed | — |
| Flucytosine 500 mg 42385-0984-01 | Laurus | 100 capsules | — | AB | FDA listed | — |
| Flucytosine 500 mg 42794-0010-08 | Sigmapharm | 30 capsules | — | AB | FDA listed | — |
| Flucytosine 500 mg 43386-0770-01 | Lupin | 100 capsules | — | AB | FDA listed | — |
| Flucytosine 500 mg 50268-0332-12 | AvPAK | 20 capsules | — | AB | FDA listed | — |
| Flucytosine 500 mg 59651-0332-01 | Aurobindo | 100 capsules | — | — | FDA listed | — |
| Flucytosine 500 mg 60687-0610-21 | American | 30 capsules | — | AB | FDA listed | — |
Where does this data come from?
⏳ 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?
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 23155-0861-01 | 100 CAPSULE in 1 BOTTLE (23155-861-01) | 2023-06-25 | Active |
| 23155-0861-03 You're viewing this | 30 CAPSULE in 1 BOTTLE (23155-861-03) | 2023-06-25 | Active |
You're viewing the smallest of 2 pack sizes for this product.
This pack shows little to no recent Medicaid volume — the 100 capsules pack carries most fills. See all packs ↓
Pack size FAQ
What quantity is in NDC 23155-0861-03?
What is the difference between NDC 23155-0861-03 and NDC 23155-0861-01?
What NDC number is used to bill for this package of Flucytosine 500 mg Capsule?
🧭 About this NDC listing & data coverage
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) | ✓ 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. |
Questions about this listing
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Do I need a prescription for this product?
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING Use with extreme caution in patients with impaired renal function. Close monitoring of hematologic, renal and hepatic status of all patients is essential. These instructions should be thoroughly reviewed before administration of Flucytosine Capsules, 250 mg and 500 mg.
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Flucytosine capsules are indicated only in the treatment of serious infections caused by susceptible strains of Candida and/or Cryptococcus . Candida: Septicemia, endocarditis and urinary system infections have been effectively treated with flucytosine. Limited trials in pulmonary infections justify the use of flucytosine.
Cryptococcus: Meningitis and pulmonary infections have been treated effectively. Studies in septicemias and urinary tract infections are limited, but good responses have been reported. Flucytosine capsules should be used in combination with amphotericin B for the treatment of systemic candidiasis and cryptococcosis because of the emergence of resistance to Flucytosine capsules (see MICROBIOLOGY ).
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION The usual dosage of flucytosine capsules are 50 to 150 mg/kg/day administered in divided doses at 6-hour intervals. Nausea or vomiting may be reduced or avoided if the capsules are given a few at a time over a 15-minute period. If the BUN or the serum creatinine is elevated, or if there are other signs of renal impairment, the initial dose should be at the lower level (see WARNINGS ).
Flucytosine capsules should be used in combination with amphotericin B for the treatment of systemic candidiasis and cryptococcosis because of the emergence of resistance to flucytosine capsules (see MICROBIOLOGY ).
⛔ Contraindications ▾
CONTRAINDICATIONS Flucytosine capsule is contraindicated in patients with a known hypersensitivity to the drug. Flucytosine capsule is contraindicated in patients with known complete dihydropyrimidine dehydrogenase (DPD) enzyme deficiency (see WARNINGS ).
⚠️ Warnings ▾
WARNINGS Flucytosine capsules must be given with extreme caution to patients with impaired renal function. Since flucytosine capsules are excreted primarily by the kidneys, renal impairment may lead to accumulation of the drug. Flucytosine capsules serum concentrations should be monitored to determine the adequacy of renal excretion in such patients.
Dosage adjustments should be made in patients with renal insufficiency to prevent progressive accumulation of active drug. Flucytosine capsules must be given with extreme caution to patients with bone marrow depression. Patients may be more prone to depression of bone marrow function if they: 1) have a hematologic disease, 2) are being treated with radiation or drugs which depress bone marrow, or 3) have a history of treatment with such drugs or radiation.
Bone marrow toxicity can be irreversible and may lead to death in immunosuppressed patients. Frequent monitoring of hepatic function and of the hematopoietic system is indicated during therapy. 5-Fluorouracil is a metabolite of flucytosine.
Dihydropyrimidine dehydrogenase is a key enzyme involved in the metabolism and elimination of 5-fluorouracil. Therefore, the risk of severe drug toxicity is increased when Flucytosine capsules are used in individuals with deficiency in DPD. Possible drug toxicities include mucositis, diarrhea, neutropenia, and neurotoxicity.
Determination of DPD activity may be considered where drug toxicity is confirmed or suspected. In the event of suspected drug toxicity, consider stopping Flucytosine capsules treatment.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The adverse reactions which have occurred during treatment with Flucytosine capsules are grouped according to organ system affected. Cardiovascular: Cardiac arrest, myocardial toxicity, ventricular dysfunction. Respiratory: Respiratory arrest, chest pain, dyspnea.
Dermatologic: Rash, pruritus, urticaria, photosensitivity. Gastrointestinal: Nausea, emesis, abdominal pain, diarrhea, anorexia, dry mouth, duodenal ulcer, gastrointestinal hemorrhage, acute hepatic injury including hepatic necrosis with possible fatal outcome in debilitated patients, hepatic dysfunction, jaundice, ulcerative colitis, enterocolitis, bilirubin elevation, increased hepatic enzymes. Genitourinary: Azotemia, creatinine and BUN elevation, crystalluria, renal failure.
Hematologic: Anemia, agranulocytosis, aplastic anemia, eosinophilia, leukopenia, pancytopenia, thrombocytopenia, and fatal cases of bone marrow aplasia. Neurologic: Ataxia, hearing loss, headache, paresthesia, parkinsonism, peripheral neuropathy, pyrexia, vertigo, sedation, convulsions. Psychiatric: Confusion, hallucinations, psychosis.
Miscellaneous: Fatigue, hypoglycemia, hypokalemia, weakness, allergic reactions, Lyell's syndrome. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or go to www.avetpharma.com.
🆘 Overdosage ▾
OVERDOSAGE There is no experience with intentional overdosage. It is reasonable to expect that overdosage may produce pronounced manifestations of the known clinical adverse reactions. Prolonged serum concentrations in excess of 100 mcg/mL may be associated with an increased incidence of toxicity, especially gastrointestinal (diarrhea, nausea, vomiting), hematologic (leukopenia, thrombocytopenia) and hepatic (hepatitis).
In the management of overdosage, prompt gastric lavage or the use of an emetic is recommended. Adequate fluid intake should be maintained, by the intravenous route if necessary, since flucytosine capsules are excreted unchanged via the renal tract. The hematologic parameters should be monitored frequently; liver and kidney function should be carefully monitored.
Should any abnormalities appear in any of these parameters, appropriate therapeutic measures should be instituted. Since hemodialysis has been shown to rapidly reduce serum concentrations in anuric patients, this method may be considered in the management of overdosage.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Flucytosine is rapidly and virtually completely absorbed following oral administration. Flucytosine capsules are not metabolized significantly when given orally to man. Bioavailability estimated by comparing the area under the curve of serum concentrations after oral and intravenous administration showed 78% to 89% absorption of the oral dose.
Peak serum concentrations of 30 to 40 mcg/mL were reached within 2 hours of administration of a 2 g oral dose to normal subjects. Other studies revealed mean serum concentrations of approximately 70 to 80 mcg/mL 1 to 2 hours after a dose in patients with normal renal function receiving a 6-week regimen of flucytosine (150 mg/kg/day given in divided doses every 6 hours) in combination with amphotericin B. The half-life in the majority of healthy subjects ranged between 2.4 and 4.8 hours.
Flucytosine is excreted via the kidneys by means of glomerular filtration without significant tubular reabsorption. More than 90% of the total radioactivity after oral administration was recovered in the urine as intact drug. Flucytosine is deaminated (probably by gut bacteria) to 5-fluorouracil.
The area under the curve (AUC) ratio of 5-fluorouracil to flucytosine is 4%. Approximately 1% of the dose is present in the urine as the α-fluoro-β-ureido-propionic acid metabolite. A small portion of the dose is excreted in the feces.
The half-life of flucytosine is prolonged in patients with renal insufficiency; the average half-life in nephrectomized or anuric patients was 85 hours (range: 29.9 to 250 hours). A linear correlation was found between the elimination rate constant of flucytosine and creatinine clearance. In vitro studies have shown that 2.9% to 4% of flucytosine is protein-bound over the range of therapeutic concentrations found in the blood.
Flucytosine readily penetrates the blood-brain barrier, achieving clinically significant concentrations in cerebrospinal fluid. Pharmacokinetics in Pediatric Patients Limited data are available regarding the pharmacokinetics of flucytosine capsules administered to neonatal patients being treated for systemic candidiasis. After five days of continuous therapy, median peak levels in infants were 19.6 mcg/mL, 27.7 mcg/mL, and 83.9 mcg/mL at doses of 25 mg/kg (N=3), 50 mg/kg (N=4), and 100 mg/kg (N=3), respectively.
Mean time to peak serum levels was of 2.5 ± 1.3 hours, similar to that observed in adult patients. A good deal of interindividual variability was noted, which did not correlate with gestational age. Some patients had serum levels > 100 mcg/mL, suggesting a need for drug level monitoring during therapy.
In another study, serum concentrations were determined during flucytosine therapy in two patients (total assays performed =10). Median serum flucytosine concentrations at steady state were calculated to be 57 ± 10 mcg/mL (doses of 50 to 125 mg/kg/day, normalized to 25 mg/kg per dose for comparison). In three infants receiving flucytosine 25 mg/kg/day (four divided doses), a median flucytosine half-life of 7.4 hours was observed, approximately double that seen in adult patients.
The concentration of flucytosine in the cerebrospinal fluid of one infant was 43 mcg/mL 3 hours after a 25 mg oral dose, and ranged from 20 to 67 mg/L in another neonate receiving oral doses of 120 to 150 mg/kg/day.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Flucytosine capsules, USP are supplied as capsules containing 250 mg and 500 mg flucytosine as follows: NDC Strength Quantity Description 23155-860-03 250 mg Bottles of 30 Green opaque cap imprinted in black with "FLU" and grey opaque body imprinted in black with "250" 23155-860-01 250 mg Bottles of 100 Green opaque cap imprinted in black with "FLU" and grey opaque body imprinted in black with "250" 23155-861-03 500 mg Bottles of 30 Grey opaque cap imprinted in black with "FLU" and white opaque body imprinted in black with "500" 23155-861-01 500 mg Bottles of 100 Grey opaque cap imprinted in black with "FLU" and white opaque body imprinted in black with "500" Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).
Manufactured by: Strides Pharma Science Limited Bengaluru - 562106, India Manufactured for: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) Revised: 04/2023 AvetLogo
📋 Description ▾
DESCRIPTION Flucytosine capsules USP, an antifungal agent, is available as 250 mg and 500 mg capsules for oral administration. In addition to the active ingredient of flucytosine, each capsule contains, corn starch, lactose monohydrate, and talc. The 250 mg capsule shell contains black iron oxide, D&C Yellow No.
10, FD&C Blue No. 1, FD&C Yellow No. 6, gelatin and titanium dioxide.
The 500 mg capsule shell contains black iron oxide, gelatin and titanium dioxide. The imprinting ink Tekprint™ SW-9008 Black contains, black iron oxide, potassium hydroxide, propylene glycol and shellac. Chemically, flucytosine is 5-fluorocytosine, a fluorinated pyrimidine which is related to fluorouracil and floxuridine.
It is a white to off-white powder with a molecular weight of 129.09 and the following structural formula: FDA approved dissolution specification differs from the USP dissolution specification. structural formula