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Voriconazole 40 mg/mL Powder, For Suspension, 75 mL — NDC 65162-913-22 (Billing 65162-0913-22)

by Amneal Pharmaceuticals LLC · 75 mL in 1 BOTTLE

This is a package of 75 mL of Voriconazole 40 mg/mL Powder, For Suspension from Amneal Pharmaceuticals LLC, marketed since Nov 2013 and currently FDA-listed; retail pharmacies pay about $5.49 per mL (NADAC). It is this product's only package size.

NDC 65162-0913-22
🏷️ FDA NDC (as labeled) 65162-913-22 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

⚠️
Other active recalls for Voriconazole (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0319-2025
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0318-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65162-913-22
Product NDC 65162-913
11-digit billing NDC 65162091322
NCPDP billing unit ML — per mL (volume)
RxCUI 465355
UNII JFU09I87TR
Application # ANDA205034
SPL Set ID ed6624a9-0b73-4a21-bf13-a8add2081d02
Established class (EPC) Azole Antifungal
Mechanism of action Cytochrome P450 3A4 Inhibitors; Cytochrome P450 2C19 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 2013-11-29
Route ORAL
Dosage form POWDER, FOR SUSPENSION
Substance VORICONAZOLE
TE code (Orange Book) AB · RLD · RS

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

GPI-14 11407080001920
GPI class Voriconazole
GCN Seq No 053774
GCN 21513
HICL code 023720
Ingredient (HICL) Voriconazole
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 VORICONAZOLE 40 MG/ML SUSP
FDB brand name Voriconazole
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 053774
  • GCN: 21513
  • GPI-14 (Medi-Span): 11407080001920
  • HICL (First Databank): 023720
  • AHFS class code: 08:14.08.00
  • RxCUI (RxNorm): 465355
Why two NDCs? The FDA registers this code as 65162-913-22 — 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 → 65162-0913-22. 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) 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 VORICONAZOLE 40 MG/ML SUSP Ingredient Voriconazole
📗 Our plain-language guide HelloPharmacist
  • It treats serious fungal infections. These include invasive aspergillosis, Candida infections in the blood or deep tissues, esophageal candidiasis, and certain Scedosporium and Fus...
  • It is usually dosed every 12 hours as a tablet, oral suspension or IV infusion. High-fat meals can lower how much medicine you absorb, so ask me about timing with food. Follow your...
  • Vision changes, fever, nausea, vomiting, rash, headache, chills, fast heartbeat and abnormal liver tests are common. Some people have hallucinations. Tell your doctor about anythin...
  • Call for yellow skin or eyes, a fast or irregular heartbeat, fainting, a severe blistering or peeling rash, or vision problems that last. Also call for chest tightness or trouble b...
📖 Read our full Voriconazole 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 mLPer package
Retail pharmacies payNADAC · weekly $5.494 $412.05 / 75 ml
Medicaid paysCMS SDUD · 12 mo $9.62 $721.16 / 75 ml
Medicare drug plans payPart D · Q2 2026 $6.83 $512.61 / 75 ml
NADAC price history (per mL) — tap or hover for the price & month
Jun 2026 Jul 2026 Aug 2026 $5.494 $5.494
Flat over the last 3 months.
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
65162-0913-22 You're viewing this Main listing 75 mL in 1 BOTTLE 2013-11-29 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Voriconazole 40 mg/mL 31722-0266-31 Camber 1 bottle $5.494 AB Availability likely —
Voriconazole 40 mg/mL 43386-0038-60 Lupin 1 bottle $5.494 AB Availability likely —
Voriconazole 40 mg/mL 59762-0935-03 Mylan 1 bottle $5.494 AB Availability likely —
Voriconazole 40 mg/mLthis 65162-0913-22 Amneal 75 ml $5.494 AB Availability likely —
voriconazole 40 mg/mL 70436-0230-39 Slate 1 bottle $5.494 AB Availability likely —
Vfend 40 mg/mL 00049-3160-44 Roerig 1 bottle — AB FDA listed —
Voriconazole 40 mg/mL 40032-0038-60 Novel 1 bottle — AB FDA listed —
voriconazole 40 mg/mL 72673-0111-30 Zhejiang 1 bottle — 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

🏛️
2013
On the market since
Nov 2013
📍
2026
Currently FDA-listed
13 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.

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.

Manufacturer & labeler

LabelerAmneal Pharmaceuticals LLC
Application holderAMNEAL PHARMACEUTICALS
FDA applicationANDA205034 (ANDA)
Labeler code65162
First marketedNov 2013
Product typeHuman Prescription Drug
Portfolio490 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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Patient Package Insert 📖 Instructions for Use 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS AND USAGE Voriconazole for oral suspension is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: Invasive aspergillosis ( 1.1 ) Candidemia in non-neutropenics and other deep tissue Candida infections ( 1.2 ) Esophageal candidiasis ( 1.3 ) Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani , in patients intolerant of, or refractory to, other therapy ( 1.4 )

1.1Invasive Aspergillosis Voriconazole for oral suspension is indicated in adults and pediatric patients (2 years of age and older) for the treatment of invasive aspergillosis (IA). In clinical trials, the majority of isolates recovered were Aspergillus fumigatus . There was a small number of cases of culture-proven disease due to species of Aspergillus other than A. fumigatus [see Clinical Studies (14.1 , 14.5 ) and Microbiology (12.4) ] .

1.2Candidemia in Non-neutropenic Patients and Other Deep Tissue Candida Infections Voriconazole for oral suspension is indicated in adults and pediatric patients (2 years of age and older) for the treatment of candidemia in non-neutropenic patients and the following Candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder wall, and wounds [see Clinical Studies (14.2 , 14.5 ) and Microbiology (12.4) ].

1.3Esophageal Candidiasis Voriconazole for oral suspension is indicated in adults and pediatric patients (2 years of age and older) for the treatment of esophageal candidiasis (EC) [see Clinical Studies (14.3 , 14.5 ) and Microbiology (12.4) ].

1.4Scedosporiosis and Fusariosis Voriconazole for oral suspension is indicated for the treatment of serious fungal infections caused by Scedosporium apiospermum (asexual form of Pseudallescheria boydii ) and Fusarium spp. including Fusarium solani , in adults and pediatric patients (2 years of age and older) intolerant of, or refractory to, other therapy [see Clinical Studies (14.4) and Microbiology (12.4) ].

1.5Usage Specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s). Therapy may be instituted before the results of the cultures and other laboratory studies are known. However, once these results become available, antifungal therapy should be adjusted accordingly.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Dosage in Adults ( 2.3 ) Infection Loading dose Maintenance Dose Intravenous infusion Intravenous infusion Oral tablets Oral suspension Invasive Aspergillosis 6 mg/kg every 12 hours for the first 24 hours 4 mg/kg every 12 hours 200 mg every 12 hours 5 mL every 12 hours Candidemia in non-neutropenics and other deep tissue Candida infections 3 to 4 mg/kg every 12 hours 200 mg every 12 hours 5 mL every 12 hours Scedosporiosis and Fusariosis 4 mg/kg every 12 hours 200 mg every 12 hours 5 mL every 12 hours Esophageal Candidiasis Not Evaluated Not Evaluated 200 mg every 12 hours 5 mL every 12 hours Adult patients weighing less than 40 kg: oral maintenance dose 100 mg or 150 mg every 12 hours.

Hepatic Impairment : Use half the maintenance dose in adult patients with mild to moderate hepatic impairment (Child-Pugh Class A and B). ( 2.5 ) Renal Impairment : Avoid intravenous administration in adult patients with moderate to severe renal impairment (creatinine clearance < 50 mL/min). ( 2.6 ) Dosage in Pediatric Patients 2 years of age and older ( 2.4 ) For pediatric patients 2 to less than 12 years of age and 12 to 14 years of age weighing less than 50 kg see Table below.

Infection Loading Dose Maintenance Dose Intravenous infusion Intravenous infusion Oral tablets Oral suspension Invasive Aspergillosis 9 mg/kg every12 hours for the first 24 hours 8 mg/kg every 12 hours after the first 24 hours 9 mg/kg every 12 hours (maximum dose of 350 mg every 12 hours) 0.225 mL/kg every 12 hours [maximum dose of 8.75 mL (350 mg) every 12 hours] Candidemia in non-neutropenics and other deep tissue Candida infections Scedosporiosis and Fusariosis Esophageal Candidiasis Not Evaluated 4 mg/kg every 12 hours 9 mg/kg every 12 hours (maximum dose of 350 mg every 12 hours) 0.225 mL/kg every 12 hours [maximum dose of 8.75 mL (350 mg) every 12 hours] For pediatric patients aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight use adult dosage.

( 2.4 ) Dosage adjustment of voriconazole in pediatric patients with renal or hepatic impairment has not been established. ( 2.5 , 2.6 ) See full prescribing information for instructions on reconstitution of voriconazole for oral suspension and important administration instructions. ( 2.1 , 2.6 , 2.7 )

2.1Important Administration Instructions for Use in All Patients Administer voriconazole for oral suspension at least one hour before or after a meal.

2.3Recommended Dosing Regimen in Adults Invasive aspergillosis and serious fungal infections due to Fusarium spp. and Scedosporium apiospermum See Table 1. Therapy must be initiated with the specified loading dose regimen of intravenous voriconazole on Day 1 followed by the recommended maintenance dose (RMD) regimen. Intravenous treatment should be continued for at least 7 days.

Once the patient has clinically improved and can tolerate medication given by mouth, the oral tablet form or for oral suspension form of voriconazole may be utilized. The recommended oral maintenance dose of 200 mg achieves a voriconazole exposure similar to 3 mg/kg intravenously; a 300 mg oral dose achieves an exposure similar to 4 mg/kg intravenously [see Clinical Pharmacology (12.3) ] . Candidemia in non-neutropenic patients and other deep tissue Candida infections See Table 1.

Patients should be treated for at least 14 days following resolution of symptoms or following last positive culture, whichever is longer. Esophageal Candidiasis See Table 1. Patients should be treated for a minimum of 14 days and for at least 7 days following resolution of symptoms.

Table 1: Recommended Dosing Regimen (Adults) Infection Loading Dose Maintenance Dose a,b Intravenous infusion Intravenous infusion Oral tablets c Oral suspension Invasive Aspergillosis d 6 mg/kg every 12 hours for the first 24 hours 4 mg/kg every 12 hours 200 mg every 12 hours 5 mL every 12 hours Candidemia in non-neutropenic patients and other deep… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 82 words ▾

3 DOSAGE FORMS AND STRENGTHS Powder for Oral Suspension Voriconazole for Oral Suspension is supplied as a white to off-white powder in 100 mL high density polyethylene (HDPE) bottles. Following reconstitution, the volume of white to off-white suspension is 75 mL, providing a usable volume of 70 mL. Each mL of the oral suspension contains 40 mg of voriconazole, USP (200 mg of voriconazole, USP per 5 mL).

For Oral Suspension : 40 mg/mL (200 mg/5 mL) when reconstituted. ( 3 )

⛔ Contraindications ~2 min read ▾

4 CONTRAINDICATIONS Voriconazole for oral suspension is contraindicated in patients with known hypersensitivity to voriconazole or its excipients [see Warnings and Precautions (5.5) and Adverse Reactions (6.1 , 6.2) ] . There is no information regarding cross-sensitivity between voriconazole and other azole antifungal agents. Refer to the prescribing information for other azole antifungal agents.

Concomitant use of voriconazole with the interacting drugs described and listed below in this section are a guide and not considered a comprehensive list of all possible drugs that may be contraindicated with voriconazole. 1. Concomitant use of voriconazole is contraindicated with drugs that are highly dependent on CYP3A4 for metabolism, and for which elevated plasma concentrations are associated with serious and/or life-threatening reactions [see Drug Interactions (7) ] : Eplerenone Ergot alkaloids (e.g., ergotamine, dihydroergotamine) Finerenone Ivabradine Lurasidone Naloxegol Pimozide Quinidine Rifabutin [see Clinical Pharmacology (12.3) ] Sirolimus [see Clinical Pharmacology (12.3) ] Tolvaptan Venetoclax: Coadministration at initiation and during the ramp-up phase is contraindicated in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) due to the potential for increased risk of tumor lysis syndrome [see Drug Interactions (7) ] .

Voclosporin 2. Concomitant use of voriconazole is contraindicated with drugs and herbal products that induce CYP2C19, CYP2C9, and/or CYP3A4 and for which significantly reduced voriconazole plasma concentrations may be associated with loss of efficacy [see Drug Interactions (7) ] : Carbamazepine Efavirenz Concomitant use with efavirenz dosages of 400 mg every 24 hours or higher is contraindicated [see Clinical Pharmacology (12.3) ] . Long-acting barbiturates Rifabutin Rifampin Ritonavir Concomitant use with high-dose ritonavir (400 mg every 12 hours) is contraindicated.

Concomitant use with low-dose ritonavir (100 mg every 12 hours) should be avoided, unless an assessment of the benefit/risk to the patient justifies the use of voriconazole [see Clinical Pharmacology (12.3) ]. St. John’s Wort [see Clinical Pharmacology (12.3) ] Known hypersensitivity to voriconazole or its excipients.

(4) Concomitant use with drugs that are highly dependent on CYP3A4 for metabolism, and for which elevated plasma concentrations are associated with serious and/or life-threatening reactions (4 , 7) Concomitant use with drugs and herbal products that induce CYP2C19, CYP2C9, and/or CYP3A4 and for which significantly reduced voriconazole plasma concentrations may be associated with loss of efficacy (4 , 7)

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Hepatic Toxicity : Serious hepatic reactions reported. Evaluate liver function tests at start of and during voriconazole therapy. ( 5.1 ) Arrhythmias and QT Prolongation : Correct potassium, magnesium and calcium prior to use; caution patients with proarrhythmic conditions.

( 5.2 ) Visual Disturbances (including optic neuritis and papilledema): Monitor visual function if treatment continues beyond 28 days. ( 5.4 ) Severe Cutaneous Adverse Reactions : Discontinue for exfoliative cutaneous reactions. ( 5.5 ) Photosensitivity : Avoid sunlight due to risk of photosensitivity.

( 5.6 ) Adrenal Dysfunction : Carefully monitor patients receiving voriconazole and corticosteroids (via all routes of administration) for adrenal dysfunction both during and after voriconazole treatment. Instruct patients to seek immediate medical care if they develop signs and symptoms of Cushing’s syndrome or adrenal insufficiency. ( 5.8 ) Embryo-Fetal Toxicity : Voriconazole can cause fetal harm when administered to a pregnant woman.

Inform pregnant patients of the potential hazard to the fetus. Advise females of reproductive potential to use effective contraception during treatment with voriconazole. ( 5.9 , 8.1 , 8.3 ) Skeletal Adverse Reactions : Fluorosis and periostitis with long-term voriconazole therapy.

Discontinue if these adverse reactions occur. ( 5.12 ) Clinically Significant Drug Interactions : Review patient’s concomitant medications. ( 5.13 , 7 )

5.1Hepatic Toxicity In clinical trials, there have been uncommon cases of serious hepatic reactions during treatment with voriconazole (including clinical hepatitis, cholestasis and fulminant hepatic failure, including fatalities). Instances of hepatic reactions were noted to occur primarily in patients with serious underlying medical conditions (predominantly hematological malignancy). Hepatic reactions, including hepatitis and jaundice, have occurred among patients with no other identifiable risk factors.

Liver dysfunction has usually been reversible on discontinuation of therapy [see Adverse Reactions (6.1) ] . A higher frequency of liver enzyme elevations was observed in the pediatric population [see Adverse Reactions (6.1) ] . Hepatic function should be monitored in both adult and pediatric patients.

Measure serum transaminase levels and bilirubin at the initiation of voriconazole therapy and monitor at least weekly for the first month of treatment. Monitoring frequency can be reduced to monthly during continued use if no clinically significant changes are noted. If liver function tests become markedly elevated compared to baseline, voriconazole should be discontinued unless the medical judgment of the benefit/risk of the treatment for the patient justifies continued use [see Dosage and Administration (2.5) and Adverse Reactions (6.1) ] .

5.2Arrhythmias and QT Prolongation Some azoles, including voriconazole, have been associated with prolongation of the QT interval on the electrocardiogram. During clinical development and post-marketing surveillance, there have been rare cases of arrhythmias, (including ventricular arrhythmias such as torsade de pointes ), cardiac arrests and sudden deaths in patients taking voriconazole. These cases usually involved seriously ill patients with multiple confounding risk factors, such as history of cardiotoxic chemotherapy, cardiomyopathy, hypokalemia and concomitant medications that may have been contributory.

Voriconazole should be administered with caution to patients with potentially proarrhythmic conditions, such as: Congenital or acquired QT prolongation Cardiomyopathy, in particular when heart failure is present Sinus bradycardia Existing symptomatic arrhythmias Concomitant medicinal product that is known to prolong QT interval [see Contraindications (4) , Drug Interactions (7) , and Clinical Pharmacology (12.3) ] Rigorous attempts to correct potassium, magnesium and calcium should be made before starting and during voricona… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Hepatic Toxicity [see Warnings and Precautions (5.1) ] Arrhythmias and QT Prolongation [see Warnings and Precautions (5.2) ] Visual Disturbances [see Warnings and Precautions (5.4) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.5) ] Photosensitivity [see Warnings and Precautions (5.6) ] Renal Toxicity [see Warnings and Precautions (5.7) ] Adult Patients : The most common adverse reactions (incidence ≥ 2%) were visual disturbances, fever, nausea, rash, vomiting, chills, headache, liver function test abnormal, tachycardia, hallucinations.

( 6 ) Pediatric Patients : The most common adverse reactions (incidence ≥5%) were visual disturbances, pyrexia, vomiting, epistaxis, nausea, rash, abdominal pain, diarrhea, hypertension, hypokalemia, cough, headache, thrombocytopenia, ALT abnormal, hypotension, peripheral edema, hyperglycemia, tachycardia, dyspnea, hypocalcemia, hypophosphatemia, LFT abnormal, mucosal inflammation, photophobia, abdominal distention, constipation, dizziness, hallucinations, hemoptysis, hypoalbuminemia, hypomagnesemia, renal impairment, upper respiratory tract infection ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trials Experience in Adults Overview The most frequently reported adverse reactions (see Table 4) in the adult therapeutic trials were visual disturbances (18.7%), fever (5.7%), nausea (5.4%), rash (5.3%), vomiting (4.4%), chills (3.7%), headache (3.0%), liver function test increased (2.7%), tachycardia (2.4%), hallucinations (2.4%).

The adverse reactions which most often led to discontinuation of voriconazole therapy were elevated liver function tests, rash, and visual disturbances [see Warning and Precautions (5.1 , 5.4 ) and Adverse Reactions (6.1) ] . The data described in Table 4 reflect exposure to voriconazole in 1,655 patients in nine therapeutic studies. This represents a heterogeneous population, including immunocompromised patients, e.g., patients with hematological malignancy or HIV and non-neutropenic patients.

This subgroup does not include healthy subjects and patients treated in the compassionate use and non-therapeutic studies. This patient population was 62% male, had a mean age of 46 years (range 11 to 90, including 51 patients aged 12 to 18 years), and was 78% White and 10% Black. Five hundred sixty one patients had a duration of voriconazole therapy of greater than 12 weeks, with 136 patients receiving voriconazole for over six months.

Table 4 includes all adverse reactions which were reported at an incidence of ≥ 2% during voriconazole therapy in the all therapeutic studies population, studies 307/602 and 608 combined, or study 305, as well as events of concern which occurred at an incidence of < 2%. In study 307/602, 381 patients (196 on voriconazole, 185 on amphotericin B) were treated to compare voriconazole to amphotericin B followed by other licensed antifungal therapy (OLAT) in the primary treatment of patients with acute IA. The rate of discontinuation from voriconazole study medication due to adverse reactions was 21.4% (42/196 patients).

In study 608, 403 patients with candidemia were treated to compare voriconazole (272 patients) to the regimen of amphotericin B followed by fluconazole (131 patients). The rate of discontinuation from voriconazole study medication due to adverse reactions was 19.5% out of 272 patients. Study 305 evaluated the effects of oral voriconazole (200 patients) and oral fluconazole (191 patients) in the treatment of EC.

The rate of dis… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Voriconazole is metabolized by cytochrome P450 isoenzymes, CYP2C19, CYP2C9, and CYP3A4. Therefore, inhibitors or inducers of these isoenzymes may increase or decrease voriconazole plasma concentrations, respectively. Voriconazole is a strong inhibitor of CYP3A4, and also inhibits CYP2C19 and CYP2C9.

Therefore, voriconazole may increase the plasma concentrations of substances metabolized by these CYP450 isoenzymes. Tables 10 and 11 provide listings of clinically significant drug interactions, including contraindicated drugs [see Contraindications (4) ] . Drugs listed in Table 10 and Table 11 are a guide and not considered a comprehensive list of all possible drugs and herbal products that are contraindicated or may interact with voriconazole.

Table 10: Effect of Other Drugs on Voriconazole Pharmacokinetics [see Clinical Pharmacology (12.3) ] Drug/Drug Class (Mechanism of Interaction by the Drug) Voriconazole Plasma Exposure (C max and AUCτ after200 mg every 12 hours) Prevention or Management Recommendations Rifampin* and Rifabutin* (CYP450 Induction) Significantly Reduced Contraindicated Efavirenz (400 mg every 24 hours)** (CYP450 Induction) Efavirenz (300 mg every 24 hours)** (CYP450 Induction) Significantly Reduced Slight Decrease in AUC τ Contraindicated When voriconazole is concomitantly administered with efavirenz, voriconazole oral maintenance dose should be increased to 400 mg every 12 hours and efavirenz should be decreased to 300 mg every 24 hours.

High-dose Ritonavir (400 mg every 12 hours)** (CYP450 Induction) Low-dose Ritonavir (100 mg every 12 hours)** (CYP450 Induction) Significantly Reduced Reduced Contraindicated Concomitant administration of voriconazole and low-dose ritonavir (100 mg every 12 hours) should be avoided, unless an assessment of the benefit/risk to the patient justifies the use of voriconazole. Carbamazepine (CYP450 Induction) Not Studied In Vivo or In Vitro , but Likely to Result in Significant Reduction Contraindicated Long Acting Barbiturates (e.g., phenobarbital, mephobarbital) (CYP450 Induction) Not Studied In Vivo or In Vitro , but Likely to Result in Significant Reduction Contraindicated Phenytoin* (CYP450 Induction) Significantly Reduced Increase voriconazole maintenance dose from 4 mg/kg to 5 mg/kg intravenous (IV) every 12 hours or from 200 mg to 400 mg orally every 12 hours (100 mg to 200 mg orally every 12 hours in patients weighing less than 40 kg).

Letermovir (CYP2C9/2C19 Induction) Reduced If concomitant administration of voriconazole with letermovir cannot be avoided, monitor for reduced effectiveness of voriconazole. St. John’s Wort (CYP450 inducer; P-gp inducer) Significantly Reduced Contraindicated Oral Contraceptives** containing ethinyl estradiol and norethindrone (CYP2C19 Inhibition) Increased Monitoring for adverse reactions and toxicity related to voriconazole is recommended for concomitant administration with oral contraceptives.

Fluconazole** (CYP2C9, CYP2C19 and CYP3A4 Inhibition) Significantly Increased Avoid concomitant administration of voriconazole and fluconazole. Monitoring for adverse reactions and toxicity related to voriconazole is started within 24 hours after the last dose of fluconazole. Other HIV Protease Inhibitors (CYP3A4 Inhibition) In Vivo Studies Showed No Significant Effects of Indinavir on Voriconazole Exposure In Vitro Studies Demonstrated Potential for Inhibition of Voriconazole Metabolism (Increased Plasma Exposure) No dosage adjustment in the voriconazole dosage needed for concomitant administration with indinavir.

Frequent monitoring for adverse reactions and toxicity related to voriconazole when co-administered with other HIV protease inhibitors. Other NNRTIs*** (CYP3A4 Inhibition or CYP450 Induction) In Vitro Studies Demonstrated Potential for Inhibition of Voriconazole Metabolism by Delavirdine and Other NNRTIs (Increased Plasma Exposure) A Voriconazole-Efavirenz Drug Interaction Study Demonstrated the Potential for the Met… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pediatrics : Safety and effectiveness in patients younger than 2 years has not been established. ( 8.4 )

8.1Pregnancy Risk Summary Voriconazole can cause fetal harm when administered to a pregnant woman. There are no available data on the use of voriconazole in pregnant women. In animal reproduction studies, oral voriconazole was associated with fetal malformations in rats and fetal toxicity in rabbits.

Cleft palates and hydronephrosis/hydroureter were observed in rat pups exposed to voriconazole during organogenesis at and above 10 mg/kg (0.3 times the RMD of 200 mg every 12 hours based on body surface area comparisons). In rabbits, embryo mortality, reduced fetal weight and increased incidence of skeletal variations, cervical ribs and extrasternal ossification sites were observed in pups when pregnant rabbits were orally dosed at 100 mg/kg (6 times the RMD based on body surface area comparisons) during organogenesis.

Rats exposed to voriconazole from implantation to weaning experienced increased gestational length and dystocia, which were associated with increased perinatal pup mortality at the 10 mg/kg dose [see Data ] . If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, inform the patient of the potential hazard to the fetus [see Warnings and Precautions (5.9) ] . The background risk of major birth defects and miscarriage for the indicated populations is unknown.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20% respectively. Data Animal Data Voriconazole was administered orally to pregnant rats during organogenesis (gestation days 6 to 17) at 10, 30, and 60 mg/kg/day. Voriconazole was associated with increased incidences of the malformations hydroureter and hydronephrosis at 10 mg/kg/day or greater, approximately 0.3 times the recommended human dose (RMD) based on body surface area comparisons, and cleft palate at 60 mg/kg , approximately 2 times the RMD based on body surface area comparisons.

Reduced ossification of sacral and caudal vertebrae, skull, pubic, and hyoid bone, supernumerary ribs, anomalies of the sternebrae, and dilatation of the ureter/renal pelvis were also observed at doses of 10 mg/kg or greater. There was no evidence of maternal toxicity at any dose. Voriconazole was administered orally to pregnant rabbits during the period of organogenesis (gestation days 7 to 19) at 10, 40, and 100 mg/kg/day.

Voriconazole was associated with increased post-implantation loss and decreased fetal body weight, in association with maternal toxicity (decreased body weight gain and food consumption) at 100 mg/kg/day (6 times the RMD based on body surface area comparisons). Fetal skeletal variations (increases in the incidence of cervical rib and extra sternebral ossification sites) were observed at 100 mg/kg/day. In a peri- and postnatal toxicity study in rats, voriconazole was administered orally to female rats from implantation through the end of lactation at 1, 3, and 10 mg/kg/day.

Voriconazole prolonged the duration of gestation and labor and produced dystocia with related increases in maternal mortality and decreases in perinatal survival of F1 pups at 10 mg/kg/day, approximately 0.3 times the RMD.

8.2Lactation Risk Summary No data are available regarding the presence of voriconazole in human milk, the effects of voriconazole on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for voriconazole and any potential adverse effects on the breastfed child from voriconazole or from the underlying maternal condition.

8.3Females and Males of Reproductive Potential Contraception Advise females of reproductive potential to use effective contraception during treatment with voriconazole. The co-administration of voricona… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 83 words ▾

10 OVERDOSAGE In clinical trials, there were three cases of accidental overdose. All occurred in pediatric patients who received up to five times the recommended intravenous dose of voriconazole. A single adverse reaction of photophobia of 10 minutes duration was reported.

There is no known antidote to voriconazole. Voriconazole is hemodialyzed with clearance of 121 mL/min. The intravenous vehicle, SBECD, is hemodialyzed with clearance of 55 mL/min.

In an overdose, hemodialysis may assist in the removal of voriconazole and SBECD from the body.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Voriconazole is an antifungal drug [see Microbiology (12.4) ] .

12.2Pharmacodynamics Exposure-Response Relationship for Efficacy and Safety In 10 clinical trials (N=1121), the median values for the average and maximum voriconazole plasma concentrations in individual patients across these studies was 2.51 mcg/mL (inter-quartile range 1.21 to 4.44 mcg/mL) and 3.79 mcg/mL (inter-quartile range 2.06 to 6.31 mcg/mL), respectively. A pharmacokinetic-pharmacodynamic analysis of patient data from 6 of these 10 clinical trials (N=280) could not detect a positive association between mean, maximum or minimum plasma voriconazole concentration and efficacy.

However, pharmacokinetic/pharmacodynamic analyses of the data from all 10 clinical trials identified positive associations between plasma voriconazole concentrations and rate of both liver function test abnormalities and visual disturbances [see Adverse Reactions (6) ] . Cardiac Electrophysiology A placebo-controlled, randomized, crossover study to evaluate the effect on the QT interval of healthy male and female subjects was conducted with three single oral doses of voriconazole and ketoconazole. Serial ECGs and plasma samples were obtained at specified intervals over a 24-hour post dose observation period.

The placebo-adjusted mean maximum increases in QTc from baseline after 800, 1200, and 1600 mg of voriconazole and after ketoconazole 800 mg were all <10 msec. Females exhibited a greater increase in QTc than males, although all mean changes were <10 msec. Age was not found to affect the magnitude of increase in QTc.

No subject in any group had an increase in QTc of ≥60 msec from baseline. No subject experienced an interval exceeding the potentially clinically relevant threshold of 500 msec. However, the QT effect of voriconazole combined with drugs known to prolong the QT interval is unknown [see Contraindications (4) and Drug Interactions (7) ] .

12.3Pharmacokinetics The pharmacokinetics of voriconazole have been characterized in healthy subjects, special populations and patients. The pharmacokinetics of voriconazole are non-linear due to saturation of its metabolism. The interindividual variability of voriconazole pharmacokinetics is high.

Greater than proportional increase in exposure is observed with increasing dose. It is estimated that, on average, increasing the oral dose from 200 mg every 12 hours to 300 mg every 12 hours leads to an approximately 2.5-fold increase in exposure (AUC τ ); similarly, increasing the intravenous dose from 3 mg/kg every 12 hours to 4 mg/kg every 12 hours produces an approximately 2.5-fold increase in exposure (Table 12). Table 12: Geometric Mean (%CV) Plasma Voriconazole Pharmacokinetic Parameters in Adults Receiving Different Dosing Regimens 6 mg/kg Intravenous ( IV) (loading dose) 3 mg/kg Intravenous ( IV) every 12 hours 4 mg/kg Intravenous ( IV) every 12 hours 400 mg Oral (loading dose) 200 mg Oral every 12 hours 300 mg Oral every 12 hours N 35 23 40 17 48 16 AUC 12 (mcg∙h/mL) 13.9 (32) 13.7 (53) 33.9 (54) 9.31 (38) 12.4 (78) 34.0 (53) C max (mcg/mL) 3.13 (20) 3.03 (25) 4.77 (36) 2.30 (19) 2.31 (48) 4.74 (35) C min (mcg/mL) -- 0.46 (97) 1.73 (74) -- 0.46 (120) 1.63 (79) Note: Parameters were estimated based on non-compartmental analysis from 5 pharmacokinetic studies.

AUC 12 = area under the curve over 12 hour dosing interval, C max = maximum plasma concentration, C min = minimum plasma concentration. CV = coefficient of variation When the recommended intravenous loading dose regimen is administered to healthy subjects, plasma concentrations close to steady-state are achieved within the first 24 hours of dosing (e.g., 6 mg/kg intravenous (IV) every 12 hours on day 1 followed by 3 mg/kg intravenous (IV) every 12 hours). Without the loading dose, accumulation occurs during twice daily multiple dosing with steady-state plasma voriconazole concentrations being achieved by day 6 in the majority of… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 198 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Powder for Oral Suspension Voriconazole for Oral Suspension, 40 mg/mL is supplied in 100 mL high density polyethylene (HDPE) bottles. Each bottle contains 45 grams of powder for oral suspension, which contain 3 g of voriconazole, USP. Following reconstitution, the volume of the suspension is 75 mL, providing a usable volume of 70 mL.

Each mL of the oral suspension contains 40 mg of voriconazole, USP (200 mg of voriconazole, USP per 5 mL). A 5 mL oral dispenser and a press-in bottle adaptor are also provided. It is available as follows: Bottle of 45 g Oral Suspension: NDC 65162-913-22

16.2Storage Voriconazole Powder for Oral Suspension should be stored at 2° to 8°C (36° to 46° F) (in a refrigerator) before reconstitution. The shelf-life of the powder for oral suspension is 24 months. The reconstituted suspension should be stored at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Do not refrigerate or freeze. Keep the container tightly closed. The shelf-life of the reconstituted suspension is 14 days.

Any remaining suspension should be discarded 14 days after reconstitution.

📋 Description 135 words ▾

11 DESCRIPTION Voriconazole USP, an azole antifungal agent is available as a powder for oral suspension. The structural formula is: Voriconazole, USP is designated chemically as (2R,3S)-2-(2, 4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1 H -1,2,4-triazol-1-yl)-2-butanol with an molecular formula of C 16 H 14 F 3 N 5 O and a molecular weight of 349.3. Voriconazole, USP drug substance is a white to light-colored powder.

Voriconazole for Oral Suspension is a white to off-white powder providing a white to off-white orange-flavored suspension when reconstituted. Bottles containing 45 grams powder for oral suspension, which contain 3 g of voriconazole USP, are intended for reconstitution with water to produce a suspension containing 40 mg/mL voriconazole, USP. The inactive ingredients include anhydrous citric acid, colloidal silicon dioxide, natural and artificial orange flavor, sodium benzoate, sodium citrate, sucrose, titanium dioxide, and xanthan gum.

1dfe1c6b-figure-01

💬 Information for Patients 165 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Visual Disturbances Patients should be instructed that visual disturbances such as blurring and sensitivity to light may occur with the use of voriconazole. Photosensitivity Advise patients of the risk of photosensitivity (with or without concomitant methotrexate), accelerated photoaging, and skin cancer.

Advise patients that voriconazole can cause serious photosensitivity and to immediately contact their healthcare provider for new or worsening skin rash. Advise patients to avoid exposure to direct sun light and to use measures such as protective clothing and sunscreen with high sun protection factor (SPF). Embryo-Fetal Toxicity Advise female patients of the potential risks to a fetus.

Advise females of reproductive potential to use effective contraception during treatment with voriconazole. This product’s labeling may have been updated. For the most recent prescribing information, please visit www.amneal.com or call 1-877-835-5472.

All brands listed are trademark of their respective owner. Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 03-2026-12

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES Voriconazole, administered orally or parenterally, has been evaluated as primary or salvage therapy in 520 patients aged 12 years and older with infections caused by Aspergillus spp., Fusarium spp., and Scedosporium spp.

14.1Invasive Aspergillosis (IA) Voriconazole was studied in patients for primary therapy of IA (randomized, controlled study 307/602), for primary and salvage therapy of aspergillosis (non-comparative study 304) and for treatment of patients with IA who were refractory to, or intolerant of, other antifungal therapy (non-comparative study 309/604). Study 307/602 – Primary Therapy of Invasive Aspergillosis The efficacy of voriconazole compared to amphotericin B in the primary treatment of acute IA was demonstrated in 277 patients treated for 12 weeks in a randomized, controlled study (Study 307/602).

The majority of study patients had underlying hematologic malignancies, including bone marrow transplantation. The study also included patients with solid organ transplantation, solid tumors, and AIDS. The patients were mainly treated for definite or probable IA of the lungs.

Other aspergillosis infections included disseminated disease, CNS infections and sinus infections. Diagnosis of definite or probable IA was made according to criteria modified from those established by the National Institute of Allergy and Infectious Diseases Mycoses Study Group/European Organisation for Research and Treatment of Cancer (NIAID MSG/EORTC). Voriconazole was administered intravenously with a loading dose of 6 mg/kg every 12 hours for the first 24 hours followed by a maintenance dose of 4 mg/kg every 12 hours for a minimum of 7 days.

Therapy could then be switched to the oral formulation at a dose of 200 mg every 12 hours. Median duration of intravenous (IV) voriconazole therapy was 10 days (range 2 to 85 days). After intravenous (IV) voriconazole therapy, the median duration of PO voriconazole therapy was 76 days (range 2 to 232 days).

Patients in the comparator group received conventional amphotericin B as a slow infusion at a daily dose of 1.0 to 1.5 mg/kg/day. Median duration of intravenous (IV) amphotericin therapy was 12 days (range 1 to 85 days). Treatment was then continued with OLAT, including itraconazole and lipid amphotericin B formulations.

Although initial therapy with conventional amphotericin B was to be continued for at least two weeks, actual duration of therapy was at the discretion of the investigator. Patients who discontinued initial randomized therapy due to toxicity or lack of efficacy were eligible to continue in the study with OLAT treatment. A satisfactory global response at 12 weeks (complete or partial resolution of all attributable symptoms, signs, radiographic/bronchoscopic abnormalities present at baseline) was seen in 53% of voriconazole treated patients compared to 32% of amphotericin B treated patients (Table 15).

A benefit of voriconazole compared to amphotericin B on patient survival at Day 84 was seen with a 71% survival rate on voriconazole compared to 58% on amphotericin B (Table 13). Table 13 also summarizes the response (success) based on mycological confirmation and species. Table 13: Overall Efficacy and Success by Species in the Primary Treatment of Acute Invasive Aspergillosis Study 307/602 Voriconazole Ampho B c Stratified Difference (95% CI) d n/N (%) n/N (%) Efficacy as Primary Therapy Satisfactory Global Response a 76/144 (53) 42/133 (32) 21.8% (10.5%, 33.0%) p < 0.0001 Survival at Day 84 b 102/144 (71) 77/133 (58) 13.1% (2.1%, 24.2%) Success by Species Success n/N (%) Overall success 76/144 (53) 42/133 (32) Mycologically confirmed e 37/84 (44) 16/67 (24) Aspergillus spp. f A. fumigatus 28/63 (44) 12/47 (26) A. flavus 3/6 4/9 A. terreus 2/3 0/3 A. niger 1/4 0/9 A. nidulans 1/1 0/0 a Assessed by independent Data Review Committee (DRC) b Proportion of subjects alive c Amphotericin B followed by other licensed antifungal therapy d Difference and corresponding 95% c… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 176 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Two-year carcinogenicity studies were conducted in rats and mice. Rats were given oral doses of 6, 18 or 50 mg/kg voriconazole, or 0.2, 0.6, or 1.6 times the RMD on a body surface area basis. Hepatocellular adenomas were detected in females at 50 mg/kg and hepatocellular carcinomas were found in males at 6 and 50 mg/kg.

Mice were given oral doses of 10, 30 or 100 mg/kg voriconazole, or 0.1, 0.4, or 1.4 times the RMD on a body surface area basis. In mice, hepatocellular adenomas were detected in males and females and hepatocellular carcinomas were detected in males at 1.4 times the RMD of voriconazole. Voriconazole demonstrated clastogenic activity (mostly chromosome breaks) in human lymphocyte cultures in vitro .

Voriconazole was not genotoxic in the Ames assay, CHO HGPRT assay, the mouse micronucleus assay or the in vivo DNA repair test (Unscheduled DNA Synthesis assay). Voriconazole administration induced no impairment of male or female fertility in rats dosed at 50 mg/kg, or 1.6 times the RMD.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION Voriconazole (vor” i kon’ a zole) for Oral Suspension, 40 mg/mL Read the Patient Information that comes with voriconazole for oral suspension before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your condition or treatment.

What is voriconazole for oral suspension? Voriconazole for oral suspension is a prescription medicine used to treat certain serious fungal infections in your blood and body. These infections are called “aspergillosis,” “esophageal candidiasis,” “ Scedosporium, ” “ Fusarium, ” and “candidemia”.

It is not known if voriconazole for oral suspension is safe and effective in children younger than 2 years old. Do not take voriconazole for oral suspension if you: are allergic to voriconazole or any of the ingredients in voriconazole for oral suspension . See the end of this leaflet for a complete list of ingredients in voriconazole for oral suspension. are taking any of the following medicines: carbamazepine efavirenz eplereone ergotamine, dihydroergotamine (ergot alkaloids) finerenone ivabradine long-acting barbiturates like phenobarbital lurasidone naloxegol pimozide quinidine rifabutin rifampin ritonavir sirolimus St.

John’s Wort (herbal supplement) tolvaptan venetoclax voclosporin Ask your healthcare provider or pharmacist if you are not sure if you are taking any of the medicines listed above. Do not start taking a new medicine without talking to your healthcare provider or pharmacist. Before you take voriconazole for oral suspension, tell your healthcare provider about all of your medical conditions, including if you: have or ever had heart disease, or an abnormal heart rate or rhythm.

Your healthcare provider may order a test to check your heart (EKG) before starting voriconazole for oral suspension. have low potassium levels, low magnesium levels, and low calcium levels. Your healthcare provider may do blood tests before starting and during treatment with voriconazole for oral suspension. have liver or kidney problems. Your healthcare provider may do blood tests to make sure you can take voriconazole for oral suspension. have trouble digesting dairy products, lactose (milk sugar), or regular table sugar.

Voriconazole for oral suspension contains sucrose (table sugar). are pregnant or plan to become pregnant. Voriconazole for oral suspension can harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.

Women who can become pregnant should use effective birth control while taking voriconazole for oral suspension. Talk to your healthcare provider about birth control methods that may be right for you. are breastfeeding or plan to breastfeed. It is not known if voriconazole passes into breast milk.

Talk to your healthcare provider about the best way to feed your baby if you take voriconazole for oral suspension. Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins and herbal supplements. Voriconazole for oral suspension may affect the way other medicines work, and other medicines may affect how voriconazole for oral suspension works.

Know what medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine. How should I take voriconazole for oral suspension?

Voriconazole may be prescribed to you as : Voriconazole for oral suspension Take voriconazole for oral suspension exactly as your healthcare provider tells you to. Take voriconazole for oral suspension at least 1 hour before or at least 1 hour after meals. Voriconazole for oral suspension will be mixed for you by your pharmacist.

Shake the bottle of voriconazole for oral suspension for 10 seconds each time before you use it. Only use the oral dispenser that comes with your voriconazole for oral suspension to administer your medicine. Do not mix vo… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

INSTRUCTIONS FOR USE Voriconazole (vor” i kon’ a zole) for Oral Suspension , 40 mg/mL Read this Instructions for Use before you start taking voriconazole for oral suspension and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

Important information: Follow your healthcare provider’s instructions for the dose of voriconazole for oral suspension to take. Ask your healthcare provider or pharmacist if you are not sure how to take voriconazole for oral suspension. Voriconazole for oral suspension is a liquid form of voriconazole.

Your pharmacist will mix (reconstitute) the medicine before it is dispensed to you. If voriconazole for oral suspension is still in powder form, do not use it. Return it to your pharmacist.

Always use the oral dispenser provided with voriconazole for oral suspension to make sure you measure the right amount of voriconazole for oral suspension. Shake the closed bottle of mixed (reconstituted) oral suspension well for about 10 seconds before each use. Each pack contains: How to prepare the bottle and take voriconazole for oral suspension: 1.

Remove the child-resistant bottle cap by pushing down while twisting the cap to the left (counter-clockwise). 2. Push the bottle adapter firmly into the bottle (if your pharmacist has not already inserted the bottle adapter).

If the bottle adapter is missing, contact your pharmacist. Do not remove the bottle adapter after it is inserted. 3.

Important: Bottle adapter must be fully inserted before use. 4. The oral dispenser has markings to measure a dose that is a whole number (1 mL, 2 mL, 3 mL, 4 mL, or 5 mL) on one side and markings to measure a dose that is not a whole number (1.25 mL, 2.5 mL, or 3.75 mL) on the other side.

Pull back on the oral dispenser plunger to your prescribed dose to fill the syringe with air. The picture above shows an example of a 3 mL dose. 5.

Insert the tip of the oral dispenser into the bottle adapter. 6. While holding the bottle with 1 hand, push down on the oral dispenser plunger with your other hand to push air into the bottle.

7. Turn the bottle upside down and slowly pull back on the oral dispenser plunger to withdraw your prescribed dose of medicine. 8.

Turn the bottle back upright with the oral dispenser still in place. Remove the tip of the oral dispenser from the bottle adapter. Place the tip of the oral dispenser in your mouth and point the tip of the oral dispenser towards the inside of the cheek.

Slowly push the plunger until all the medicine is given. Do not squirt the medicine out quickly. This may cause you to choke.

If the medicine is to be given to a child, keep your child in an upright position while giving the medicine. If your dose is more than 5 mL, repeat step 4 through step 8 to give the remaining part of your dose. For example, if your dose is 8.75 mL measure and give 5 mL first and then measure and give 3.75 mL.

9. Screw the bottle cap back on the bottle tightly by turning the cap to the right (clockwise). Do not remove the bottle adapter.

The bottle cap will fit over it. Rinse the oral dispenser after each use. Pull the plunger out of the oral dispenser and wash both parts with warm soapy water.

Rinse both parts with water and allow to air dry after each use. After air drying, push the plunger back into the oral dispenser. Store the oral dispenser with voriconazole for oral suspension in a clean safe place.

How should I store voriconazole for oral suspension? Store voriconazole for oral suspension at room temperature between 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). Do not refrigerate or freeze.

Keep the bottle cap tightly closed. Use voriconazole for oral suspension within 14 days after it has been mixed (reconstituted) by the pharmacist. The pharmacist will write the expiration date on the bottle label (the expiration date of the oral suspensi… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 6 words ▾

RECENT MAJOR CHANGES Contraindications (4) 1/2026

📄 Package Label / Principal Display Panel 6 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Label Carton

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
65
Units reimbursed last 4 qtrs
18K
Gross reimbursed last 4 qtrs
$173.1K
Avg / prescription
$2,662.87
Avg / unit
$9.6154
Latest quarter Q1 2026
37Rx
Medicaid pays / mL
$9.6154
gross reimbursed
vs
NADAC / mL
$5.4940
acquisition cost
=
Spread
+$4.1214
+75% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
78% FFS 22% MCO
Fee-for-service · 51 Rx Managed care · 14 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 1,425 units · 7.3 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 13,876 units · 35.6 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 2,700 units · 8.9 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
7.335.6
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 California 35.6 /100k
2 Texas 8.9 /100k
3 New York 7.3 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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

Medicare Part D (outpatient prescription) spending for Voriconazole — 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 Voriconazole. 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
$2.6M
Claims incl. refills
9.8K
Beneficiaries
5.3K
Spend / beneficiary
$486.76
Spend / claim
$266.49
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.
← 65162-0911-74 · Amneal 65162-0914-46 · Amneal →
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.