FDA-filed SPL labeling · retrieved through openFDA

Posaconazole

Posaconazole is an azole antifungal used to treat serious fungal infections, including invasive aspergillosis and oropharyngeal candidiasis, and to prevent dangerous fungal infections in people with severely weakened immune systems.

Brand names NoxafilNoxafil PowderMix
Drug class ⓘ Azole Antifungal
Rx Forms 5 Routes Oral · Intravenous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 26 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveFeb 13, 2026
Clinical labels in scope ⓘ26
AvailabilityRx
Earliest approval/marketing year ⓘ2006
FDA-listed product records ⓘ104
Boxed warningNone found in compared labels
How we combine label and product data →
Other forms & routes:
⭐ Posaconazole at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Posaconazole is a powerful antifungal used to treat or prevent serious, potentially life-threatening fungal infections in people with weakened immune systems. The formulation you receive matters — tablets, suspension, and IV injection are not interchangeable and are approved for different situations, ages, and weights. Because posaconazole interacts significantly with many common medications, always make sure every member of your care team knows you're taking it.

📖 Posaconazole: Patient Information Guide

A plain-language walkthrough of Posaconazole — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Posaconazole is an azole antifungal available in multiple formulations, each approved for specific uses, ages, and weights. Here is the full supported indication set:

  • Treatment of invasive aspergillosis (serious mold infection):
    • Posaconazole injection and Noxafil injection: adults and pediatric patients 2 years and older weighing at least 10 kg
    • Delayed-release tablets: adults and pediatric patients 2 years and older weighing more than 40 kg (some generics specify 13 years and older)
    • Noxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years and older weighing 10–40 kg
  • Prophylaxis (prevention) of invasive Aspergillus and Candida infections in severely immunocompromised patients (e.g., stem cell transplant recipients with GVHD, or blood cancer patients with prolonged low white cell counts from chemotherapy):
    • Posaconazole injection and Noxafil injection: adults and pediatric patients 2 years and older weighing at least 10 kg
    • Delayed-release tablets: adults and pediatric patients 2 years and older weighing more than 40 kg (some generics specify 13 years and older)
    • Oral suspension (Noxafil and generic): adults and pediatric patients 13 years and older
    • Noxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years and older weighing 10–40 kg
  • Treatment of oropharyngeal candidiasis (OPC) — yeast infection of the mouth and throat, including cases resistant to itraconazole and/or fluconazole:
    • Oral suspension only (Noxafil and generic): adults and pediatric patients 13 years and older
⚙️How it works▾

Posaconazole is an azole antifungal. It works by blocking a critical enzyme that fungi need to produce ergosterol — the main building block of their cell membrane. Without a functional membrane, fungal cells cannot maintain their structure and die off, stopping the infection from spreading.

Because posaconazole is a strong inhibitor of the liver enzyme CYP3A4, it can raise blood levels of many other medications processed by that enzyme. This is an important reason why it interacts with so many drugs.

💊How it's taken▾

Posaconazole is available as an injection (IV), delayed-release tablets, and an oral suspension — and these forms are not interchangeable because they have different dosing regimens approved for different uses, ages, and weights.

  • IV injection: Given by slow infusion over about 90 minutes through a central venous line — never injected as a rapid bolus. A loading dose is typically given twice in the first day, then once daily thereafter.
  • Delayed-release tablets: Taken by mouth with or without food. A loading dose is given twice on the first day, followed by once-daily dosing. Switching between IV and delayed-release tablets is acceptable without a new loading dose.
  • Oral suspension: Must be taken with a full meal to ensure adequate absorption. Dosing schedule differs from the tablet — follow your prescriber's instructions closely.

Always follow the dosing instructions specific to your formulation, age, weight, and indication. Never switch formulations without direction from your prescriber or pharmacist.

🤒Side effects — in detail▾

Side effects vary somewhat by formulation and indication, but the most commonly reported ones include:

  • Diarrhea, nausea, and vomiting
  • Fever (pyrexia)
  • Headache
  • Low potassium levels (hypokalemia)
  • Low magnesium levels (hypomagnesemia)
  • Rash
  • Elevated liver enzymes (seen on blood tests)
  • Swelling in the legs or feet (peripheral edema)

More serious reactions to act on promptly include signs of liver damage (yellowing of the skin or eyes, severe fatigue), irregular heartbeat or palpitations, signs of very high drug levels of medications like tacrolimus or cyclosporine (confusion, kidney problems), and any unusual neurological symptoms if you are also taking vincristine.

⚠️Warnings & precautions▾
  • Heart rhythm changes (QT prolongation and torsades de pointes): Posaconazole can alter the heart's electrical activity. It must not be combined with pimozide, quinidine, or other CYP3A4 substrates that also prolong heart rhythm. Low potassium or magnesium worsens this risk.
  • Drug interactions with immunosuppressants: Posaconazole dramatically raises blood levels of tacrolimus (~2–3×), cyclosporine, and sirolimus (~9×). Kidney damage and serious toxicity, including deaths, have occurred. Dose reductions and frequent blood level checks are required.
  • Liver toxicity: Elevated liver enzymes can occur. Your doctor may monitor liver function during treatment and may stop posaconazole if levels become abnormal.
  • Pseudoaldosteronism: A rare hormonal imbalance causing rising blood pressure and low potassium — your blood pressure and potassium levels should be monitored.
  • Electrolyte imbalances: Low potassium, magnesium, or calcium should be corrected before and during treatment.
  • Vincristine toxicity: Combining posaconazole with the chemotherapy drug vincristine can cause serious nerve damage. Use only when no alternative antifungal is available.
  • Breakthrough fungal infections: Patients with severe diarrhea or vomiting while on delayed-release tablets should be monitored closely, as absorption may be reduced.
🔀What it interacts with▾

Posaconazole is a strong inhibitor of the liver enzyme CYP3A4, meaning it can significantly raise blood levels of many other drugs. It is also affected by drugs that speed up its own clearance. Key interactions include:

  • Sirolimus: Levels rise ~9-fold — combination is contraindicated due to risk of serious toxicity
  • Certain statins (atorvastatin, lovastatin, simvastatin): Levels rise dramatically — combination is contraindicated due to risk of rhabdomyolysis (severe muscle breakdown)
  • Pimozide and quinidine: Heart rhythm risk — combination is contraindicated
  • Ergot alkaloids (ergotamine, dihydroergotamine): Risk of ergotism (dangerous blood vessel spasm) — combination is contraindicated
  • Venetoclax: Risk of tumor lysis syndrome — contraindicated at initiation and ramp-up in CLL/SLL patients
  • Tacrolimus and cyclosporine: Levels rise significantly — require dose reduction and frequent monitoring
  • Rifabutin, phenytoin, efavirenz, fosamprenavir: These lower posaconazole levels, reducing its effectiveness — avoid or monitor closely
  • Benzodiazepines (midazolam, alprazolam, triazolam): Levels rise ~5-fold — risk of prolonged sedation; monitor closely
  • Calcium channel blockers (verapamil, diltiazem, nifedipine): Levels increase — monitor for side effects
  • Digoxin: Levels may increase — monitor digoxin blood concentrations
  • Vincristine and other vinca alkaloids: Risk of serious nerve damage — use only if no alternative antifungal exists

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • You are allergic to posaconazole or any other azole antifungal (e.g., fluconazole, itraconazole, voriconazole)
  • You take sirolimus, certain statins (atorvastatin, lovastatin, simvastatin), pimozide, quinidine, ergot alkaloids, or venetoclax (in specific circumstances) — these combinations are contraindicated
  • You are pregnant or planning to become pregnant — animal studies show potential for fetal harm; discuss the risks with your doctor
  • You are breastfeeding — it is not known if posaconazole passes into human milk; weigh the risks with your doctor
  • Your child is under 2 years old — safety and effectiveness have not been established
  • You have severe kidney impairment — the IV injection form should be avoided and oral forms require close monitoring
  • You have liver disease or abnormal liver tests — liver function should be monitored during treatment
  • You have heart rhythm problems, or low potassium or magnesium levels — these increase the risk of heart rhythm complications
  • You have hereditary fructose intolerance (HFI) — the Noxafil PowderMix for delayed-release oral suspension is contraindicated
  • You are older than 65 — no dose adjustment is needed, but your doctor should be aware of all other medications you take
🚑If you take too much▾

There is no experience with overdose of the IV injection form. In clinical trials, some patients took much higher-than-normal oral doses and did not experience side effects different from lower doses. One patient accidentally took a very high dose of the oral suspension for three days with no serious effects noted.

Posaconazole is not removed by hemodialysis (kidney dialysis). If you think you or someone else has taken too much, contact a poison control center or seek emergency medical care.

📡Pharmacodynamics — effects in the body▾

In clinical studies of patients at high risk of fungal infections, higher posaconazole blood concentrations were associated with better protection against breakthrough infections when using the oral suspension. Patients with the lowest drug levels had the highest rates of treatment failure, defined as needing to switch antifungals or developing a breakthrough fungal infection.

For treatment of invasive aspergillosis with the injection or delayed-release tablets, no clear link was found between drug blood levels and treatment success across the studied range, suggesting that achieving adequate exposure is important but levels within the studied range may be sufficient.

🔬Pharmacokinetics — how your body processes it▾

After IV infusion, posaconazole distributes widely throughout the body (large volume of distribution) and is more than 98% bound to proteins in the blood, mainly albumin. It is primarily broken down in the body through a process called glucuronidation (a phase 2 liver process), not the typical CYP450 oxidative pathway — though it does strongly inhibit the CYP3A4 enzyme, affecting many other drugs. The drug's half-life (time for blood levels to fall by half) is roughly 24 hours for the IV form and about 31 hours for the delayed-release tablets in healthy volunteers.

The oral suspension must be taken with a full meal because food significantly improves absorption. The delayed-release tablet formulation, however, can be taken with or without food and generally provides more consistent drug levels. Posaconazole is mainly eliminated in the feces; only a small fraction leaves the body through the urine, and kidney dialysis does not remove it from the blood.

📦How to store it▾

Store Noxafil injection vial refrigerated at 2 to 8°C (36 to 46°F). for the diluted Noxafil infusion solution are presented in another section of the prescribing information . Store at 20 to 25°C (68 to 77°F), excursions permitted to 15 to 30°C (59 to 86°F) .

📄 Written from Posaconazole’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

17

Supplements & herbs that interact with Posaconazole

17 supplements and herbal products have documented interactions with Posaconazole in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 1
  • Moderate · 7
  • Minor · 9
Every supplement checked against Posaconazole — ranked by severity The full interaction hub: 1 major · 7 moderate · 9 minor · every one linked to its full report. Check Posaconazole against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Posaconazole — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is posaconazole treating — what kind of infection is this? ▾
Posaconazole fights serious fungal infections, not bacterial ones. Depending on your situation, you may be taking it to treat invasive aspergillosis — a mold infection that can affect the lungs and spread — or a yeast infection of the mouth and throat called oropharyngeal candidiasis. Some people take it purely as prevention if their immune system is significantly suppressed, such as after a bone marrow transplant or during intensive chemotherapy. Your prescriber chose it because these types of fungal infections can be very serious in people with weakened immune systems.
Does it matter if I take the tablets with food or not? ▾
It depends on which form you have. The delayed-release tablets can be taken with or without food — that's one of their advantages. But if you have the oral suspension (the liquid), you absolutely need to take it with a full meal to make sure your body absorbs enough of the medication. Taking the suspension without food can significantly reduce how much drug gets into your system, which could mean the treatment doesn't work as well. When in doubt, check the label on your specific bottle or ask your pharmacist.
Can I switch between the liquid and the tablets on my own if I run out of one? ▾
No — please don't switch on your own. The different formulations of posaconazole are not interchangeable. They have different doses, different dosing schedules, and are approved for different situations. Swapping without guidance from your prescriber or pharmacist could mean you get too little drug (and the infection isn't treated) or cause confusion about dosing. If you're having trouble getting one form, call your prescriber or pharmacist right away so they can manage the switch properly.
I take several other medications. Should I be worried about interactions? ▾
Yes, this is one of the most important things to discuss with your pharmacist or doctor. Posaconazole affects a key liver enzyme called CYP3A4, which means it can raise the blood levels of many other drugs to potentially dangerous levels. Some combinations — like certain statins (cholesterol drugs), sirolimus (an immune suppressant), or specific heart rhythm medications — are actually contraindicated, meaning they should never be used together. Even common drugs like tacrolimus or cyclosporine need dose adjustments. Bring a complete list of everything you take — prescriptions, over-the-counter drugs, and supplements — so your team can check for problems.
What side effects should I just watch for versus ones that need an urgent call to the doctor? ▾
Common side effects you might notice include nausea, diarrhea, vomiting, fever, and headache — these are worth mentioning at your next appointment but usually don't require emergency action. However, call your doctor promptly if you notice yellowing of your skin or eyes, very dark urine, or severe fatigue (possible liver problems); irregular heartbeat or palpitations; significant weakness, rising blood pressure, or muscle cramps (possibly low potassium); or any new nerve symptoms like tingling or unusual weakness, especially if you're also on vincristine. These are the warning signs that need attention sooner rather than later.
Is posaconazole safe to take if I'm pregnant or trying to get pregnant? ▾
This is really a conversation to have with your doctor before starting. Animal studies showed posaconazole could cause harm to a developing fetus at certain doses, so there is a potential risk during pregnancy — though we don't have enough data in humans to know the exact risk. If you're pregnant, planning to become pregnant, or breastfeeding, make sure your prescriber knows. They'll weigh the seriousness of your fungal infection against the potential risks and guide you on the safest path forward.
Is Posaconazole available over the counter? ▾
Posaconazole is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Posaconazole first available? ▾
Posaconazole has been available in the United States since at least 2006, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Posaconazole? ▾
Posaconazole is supplied by 50 manufacturers listed in the FDA NDC Directory, including Merck Sharp & Dohme LLC, Bryant Ranch Prepack, Zhejiang Ausun Pharmaceutical Co., Ltd..

💬 Answers drafted from Posaconazole’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Posaconazole comes

Posaconazole is available in 5 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Delayed-release tablet

By mouth
Available strengths 1 strength
40 FDA-listed product records ⓘ

Injection

Into a vein
Brands Noxafil
Available strengths 1 strength
16 FDA-listed product records ⓘ

Tablet

By mouth
Brands Noxafil
Available strengths 1 strength
14 FDA-listed product records ⓘ

Oral suspension

By mouth
Brands Noxafil
Available strengths 2 strengths
12 FDA-listed product records ⓘ

Oral solution

By mouth
Available strengths 1 strength
1 FDA-listed product record ⓘ

📊 Posaconazole across the U.S. market

How Posaconazole appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

5
Dose forms ⓘ
50
Manufacturers
2
Brand names
104
FDA-listed product records ⓘ
2006
First marketed ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (20) · Granule (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Merck Sharp & Dohme LLC13%
Bryant Ranch Prepack6%
Zhejiang Ausun Pharmaceutical Co., Ltd.4%
American Health Packaging3%
Par Pharmaceutical Inc.3%
SpecGx LLC3%
Other makers67%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Posaconazole is used

A general measure of how commonly Posaconazole is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Posaconazole is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

8,341
Medicaid prescriptions filled (Q1–Q4 2025)
$4.6M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Posaconazole prescribed? Of the 1,597 medications we measure, Posaconazole ranks #961 by Medicaid prescriptions — more than 40% of them.

Where Posaconazole ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Posaconazole product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 100 mg delayed release oral tablet is the most-dispensed Posaconazole product — about 96% of these Medicaid prescriptions.

posaconazole 100 MG Delayed Release Oral Tablet Most dispensed

7,982 Medicaid prescriptions (Q1–Q4 2025) 96% of Posaconazole prescriptions shown $3.4M gross reimbursement (before rebates) ≈ $428 per prescription (gross)

Summed across the 11 of 41 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1482908

posaconazole 40 MG/ML Oral Suspension

304 Medicaid prescriptions (Q1–Q4 2025) 4% of Posaconazole prescriptions shown $886,866 gross reimbursement (before rebates) ≈ $2,917 per prescription (gross)

Summed across the 2 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 665019

16.7 ML posaconazole 18 MG/ML Injection

55 Medicaid prescriptions (Q1–Q4 2025) <1% of Posaconazole prescriptions shown $291,979 gross reimbursement (before rebates) ≈ $5,309 per prescription (gross)

Summed across the 3 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1492043

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Posaconazole, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 16 of 54 listed Posaconazole NDCs with Medicaid activity.

🔍 Compare Posaconazole products

A representative set of FDA-listed product records for Posaconazole — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 104 of 104 products — FDA National Drug Code Directory. See every product, package size and price: browse all 104 Posaconazole NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Posaconazole RxCUI 282446 4 dose forms · 4 strengths
  1. Dose form (SCDF) Delayed Release Oral Tablet RxCUI 1482907 In current FDA listings
    Clinical drug / strength (SCD) 100 MG RxCUI 1482908
  2. Dose form (SCDF) Injection RxCUI 1724193 In current FDA listings
    Clinical drug / strength (SCD) 16.7 ML posaconazole 18 MG/ML RxCUI 1492043
  3. Dose form (SCDF) Oral Suspension RxCUI 665018 In current FDA listings
    Clinical drug / strength (SCD) 40 MG/ML RxCUI 665019
  4. Dose form (SCDF) Powder for Oral Suspension RxCUI 2558602 In current FDA listings
    Clinical drug / strength (SCD) 300 MG RxCUI 2558603

Look up RxCUI 282446 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Noxafil Noxafil PowderMix

🏭 Manufacturers & labelers

Merck Sharp & Dohme LLC 12 Bryant Ranch Prepack 6 Zhejiang Ausun Pharmaceutical Co., Ltd. 4 American Health Packaging 3 Par Pharmaceutical Inc. 3 SpecGx LLC 3 Lupin Pharmaceuticals, Inc. 3 Hikma Pharmaceuticals USA Inc. 3 Glenmark Pharmaceuticals Inc., Usa 3 Dr.Reddys Laboratories Inc 3 BrightGene Bio-Medical Technology Co., Ltd. 3 Major Pharmaceuticals 2 Atlantic Biologicals Corp. 2 Lannett Company Inc. 2 i3 Pharmaceuticals, LLC 2 Metrochem Api Private Limited 2 Aurobindo Pharma Limited 2 Golden State Medical Supply, Inc. 2 AvKARE 2 Gland Pharma Limited 2 MSN Laboratories Private Limited 2 AvPAK 2 Eugia US LLC 2 ENDO USA, Inc. 2

…and 16 more on the FDA NDC directory.

RxNorm drug class

Posaconazole belongs to the Azole Antifungal class.

Pharmacologic class Azole Antifungal
Drug family (ATC) Triazole and tetrazole derivatives

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Feb 13, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Posaconazole.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Posaconazole after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
26
NDC products indexed
104
Distinct labelers/manufacturers represented
50
Linked representative label ⓘ
Merck Sharp & Dohme LLC
Linked label effective
Feb 13, 2026
Composite sections available
24
Linked SPL Set ID
b073b082-7b57-4423-8c06-4fd4263d6f84
Linked SPL Document ID
56740f7d-3b29-4786-b5c7-eea6c0f14400
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 26 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Merck Sharp & Dohme LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.