FDA-filed SPL labeling · retrieved through openFDA

Letermovir

Letermovir (Prevymis) is an antiviral medicine used to prevent cytomegalovirus (CMV) infection and disease in certain transplant patients.

Brand name Prevymis
Drug class ⓘ Cytomegalovirus Dna Terminase Complex Inhibitor
Rx Forms 3 Routes Intravenous · Oral
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 1 clinical label set 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 effectiveJan 14, 2026
AvailabilityRx
Earliest approval/marketing year ⓘ2017
FDA-listed product records ⓘ21
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 24, 2026
Other forms & routes:
⭐ Letermovir at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Prevymis (letermovir) is a once-daily antiviral used to prevent CMV infection in stem cell transplant recipients and high-risk kidney transplant patients. It has important interactions with many common transplant medications, so your full medication list must be reviewed before and during treatment. Take it exactly as prescribed, and contact your care team promptly if you notice unusual muscle pain, heart symptoms, or signs of an allergic reaction.

📖 Letermovir: Patient Information Guide

A plain-language walkthrough of Letermovir — 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▾

Prevymis (letermovir) is an antiviral medicine approved to prevent CMV (cytomegalovirus) in specific groups of transplant patients.

  • Stem cell transplant (HSCT) recipients: Prevymis is approved to prevent CMV infection and disease in adults and children 6 months of age and older, weighing at least 6 kg, who received a stem cell transplant from a donor and who themselves carry the CMV virus (CMV-seropositive).
  • Kidney transplant recipients: Prevymis is approved to prevent CMV disease in adults and children 12 years of age and older, weighing at least 40 kg, who received a kidney transplant and are at high risk — meaning the donor tested CMV-positive and the recipient tested CMV-negative (D+/R-).
⚙️How it works▾

Letermovir works by blocking a viral protein complex called the CMV DNA terminase complex. This complex is essential for the cytomegalovirus to cut and package its DNA into new viral particles. Without this step, the virus cannot make functional copies of itself and spread through the body. Because this target is specific to CMV and not found in human cells, letermovir can attack the virus without using the same mechanism as older antivirals.

💊How it's taken▾

Prevymis is taken once daily, by mouth or by IV infusion, depending on which form your care team prescribes. Tablets can be taken with or without food and must be swallowed whole. Oral pellets are mixed with soft food or administered through a feeding tube. The IV infusion is given over one hour in a clinical setting and is reserved for patients who cannot take oral medication.

  • For stem cell transplant patients, treatment is typically started between the day of transplant and Day 28, and continued through Day 100 — or up to Day 200 for those at higher risk of late CMV reactivation.
  • For kidney transplant patients, treatment starts between Day 0 and Day 7 after transplant and continues through Day 200.
  • If you also take cyclosporine, your dose of Prevymis will be adjusted — do not change your dose on your own.
🤒Side effects — in detail▾

The most commonly reported side effects during clinical trials include:

  • Nausea
  • Diarrhea
  • Vomiting
  • Swelling in the legs or feet (peripheral edema)
  • Cough
  • Headache
  • Fatigue
  • Abdominal pain

A higher rate of cardiac events such as rapid heartbeat (tachycardia) and atrial fibrillation was seen in Prevymis-treated stem cell transplant patients compared to placebo — though most were mild to moderate. Let your care team know right away if you experience a fast or irregular heartbeat, difficulty breathing, severe allergic reaction, or unusual muscle pain or weakness.

⚠️Warnings & precautions▾
  • Drug interactions are the biggest concern. Prevymis affects and is affected by many medications commonly used in transplant care. Some combinations are prohibited entirely (pimozide, ergot alkaloids, and certain statins with cyclosporine). Others require close monitoring or dose changes. Your full medication list must be reviewed before and throughout treatment.
  • IV form contains hydroxypropyl betadex. This inactive ingredient can accumulate in patients with reduced kidney function. Animal studies have shown it may affect hearing. The IV form should only be used when oral treatment is not possible, and for no longer than 4 weeks if avoidable. Kidney function should be monitored closely in patients with significant renal impairment using the IV form.
  • Severe liver disease: Prevymis is not recommended for patients with severe hepatic (liver) impairment.
🔀What it interacts with▾

Prevymis has a wide range of significant drug interactions — always share your full medication list with your prescriber and pharmacist before starting.

  • Pimozide: Contraindicated — Prevymis raises pimozide levels, risking dangerous heart rhythm problems (QT prolongation, torsades de pointes).
  • Ergot alkaloids (ergotamine, dihydroergotamine): Contraindicated — Prevymis raises their levels, risking ergotism (severe, dangerous blood vessel spasm).
  • Pitavastatin and simvastatin + cyclosporine: Contraindicated — the combination dramatically raises statin levels, risking serious muscle damage (myopathy or rhabdomyolysis).
  • Cyclosporine: Raises letermovir levels significantly; a lower Prevymis dose is required when these are taken together.
  • Other statins (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin): Prevymis increases their levels; dose limits or reductions apply; monitor for muscle pain.
  • Tacrolimus and sirolimus (transplant immunosuppressants): Prevymis raises blood levels; frequent monitoring and dose adjustment of these drugs are needed.
  • Warfarin: Prevymis lowers warfarin levels; monitor INR closely to maintain anticoagulation.
  • Carbamazepine, phenobarbital, phenytoin, rifampin, rifabutin, nafcillin, St. John's Wort, efavirenz, etravirine, nevirapine, bosentan, modafinil, thioridazine: These can reduce Prevymis levels, potentially making it less effective; co-use is generally not recommended.
  • Antidiabetic agents (glyburide, repaglinide, rosiglitazone): Prevymis may raise their levels; monitor blood glucose closely.
  • Proton pump inhibitors (omeprazole, pantoprazole): Prevymis may lower their levels; clinical monitoring may be needed.

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▾
  • Current medications: Tell your prescriber about every drug, supplement, and herbal product you take — the interaction list for Prevymis is long and includes common transplant medications.
  • Kidney problems: If you have reduced kidney function and will use the IV form, your care team must monitor your kidney function closely due to buildup of the IV vehicle (hydroxypropyl betadex).
  • Liver problems: Prevymis is not recommended for patients with severe hepatic impairment (Child-Pugh Class C). No dose adjustment is needed for mild or moderate liver disease.
  • Pregnancy: Animal studies showed potential harm to fetuses; the risk to human pregnancies is not fully known. Discuss with your doctor if you are pregnant or planning to become pregnant.
  • Breastfeeding: It is not known if letermovir passes into human breast milk. Weigh the benefits of breastfeeding against potential risks with your doctor.
  • Children: Prevymis is approved for stem cell transplant recipients as young as 6 months (weighing at least 6 kg), but is not established for kidney transplant patients under 12 years old or under 40 kg.
  • Older adults: No dose adjustment is needed based on age alone; safety and efficacy were similar across age groups in clinical trials.
🚑If you take too much▾

There is no specific antidote for a Prevymis overdose. If too much is taken, medical staff will monitor for side effects and provide supportive treatment as needed. It is not known whether dialysis can meaningfully remove letermovir from the body.

📡Pharmacodynamics — effects in the body▾

In a dedicated cardiac safety study in healthy adults, letermovir at the approved IV dose — and even at twice that dose — did not cause clinically meaningful prolongation of the QTc interval (the heart's electrical recovery time). This means Prevymis itself is not expected to directly affect heart rhythm in the way some other drugs can, though cardiac monitoring is still recommended given the complexity of the patient population.

🔬Pharmacokinetics — how your body processes it▾

After an oral dose, letermovir is absorbed relatively quickly, with peak blood levels reached within about 1.5 to 3 hours. Food does not meaningfully change the total amount absorbed (though it can modestly increase the peak level), so tablets can be taken with or without a meal. Letermovir is very heavily bound to proteins in the blood (about 99%) and is eliminated primarily through the liver; about 93% of a dose leaves the body through the feces. The drug has a half-life of roughly 12 hours, and steady blood levels are reached after about 9 to 10 days. Oral bioavailability (how much of the drug reaches the bloodstream) varies by patient population and whether cyclosporine is used at the same time — cyclosporine significantly increases letermovir exposure, which is why a dose adjustment is required.

📦How to store it▾

Store PREVYMIS tablets in the original package until use to protect from moisture. Store PREVYMIS tablets at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) .

📄 Written from Letermovir’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 →

🩺 Pharmacist Counseling Corner

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

What exactly is Prevymis being used for in my situation? ▾
Prevymis is an antiviral medicine prescribed to prevent a virus called CMV — cytomegalovirus — from activating after your transplant. Many people carry CMV without any symptoms, but after a transplant, when your immune system is suppressed, the virus can reactivate and cause serious illness. Prevymis works by blocking the virus from making copies of itself before it can cause disease.
Can I take my tablet with food, or does it need to be on an empty stomach? ▾
Good news — you can take your Prevymis tablet with or without food, so there's no need to time it around meals. Just try to take it at the same time each day to keep your levels consistent. If you're using the oral pellets, those get mixed into soft food, so eating is part of how you take them.
What side effects should I expect, and when should I call my doctor? ▾
The most common side effects are nausea, diarrhea, vomiting, swelling in the feet or legs, cough, headache, fatigue, and stomach pain. These are generally manageable, and most people who stopped the drug in studies did so because of nausea. That said, call your doctor right away if you notice a fast or irregular heartbeat, severe difficulty breathing, signs of an allergic reaction, or unusual muscle pain or weakness — those need to be checked out promptly.
I'm on several other medications for my transplant. Is that a problem with Prevymis? ▾
Drug interactions are probably the most important thing to know about Prevymis. It can raise the blood levels of several common transplant drugs — including tacrolimus, sirolimus, and cyclosporine — which means your care team will likely need to check those levels more often and possibly adjust those doses. Some combinations are completely off-limits, like pimozide or ergot-based migraine medicines. Always make sure every member of your care team has your full medication list, including any supplements or herbal products like St. John's Wort.
I'm getting the IV form in the hospital. Is that the same as the pill? ▾
The IV form delivers letermovir directly into your bloodstream and is used when you can't take anything by mouth. The IV version contains an inactive ingredient called hydroxypropyl betadex, which can build up if your kidneys aren't working well, so your kidney function will be monitored. As soon as you're able to swallow, your team will switch you to the oral form — the goal is to use the IV version for as short a time as possible.
Is Prevymis safe during pregnancy? ▾
There's no solid human data yet on whether Prevymis is safe during pregnancy. Animal studies did show potential harm to developing fetuses at higher doses. If you're pregnant, planning to become pregnant, or breastfeeding, it's really important to have that conversation with your doctor so you can weigh the risks and benefits for your specific situation. Don't stop any prescribed medication on your own without talking to your care team first.
Is Letermovir available over the counter? ▾
Letermovir 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 Letermovir first available? ▾
Letermovir has been available in the United States since at least 2017, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Letermovir? ▾
Letermovir is supplied by 7 manufacturers listed in the FDA NDC Directory, including Merck Sharp & Dohme LLC, MSD International GmbH, Honour Lab Limited.

💬 Answers drafted from Letermovir’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 Letermovir comes

Letermovir is available in 3 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.

Injection

By injection · Into a vein
Brands Prevymis
How this form is used
What it may be used for
  • Prevymis injection is used to prevent CMV infection and disease in eligible stem cell transplant recipients who cannot take oral medication
  • Prevymis injection is used to prevent CMV disease in eligible high-risk kidney transplant recipients who cannot take oral medication
Important instructions
  • Prevymis injection must be diluted before use and administered as an intravenous (IV) infusion over exactly one hour — it must not be given as a rapid bolus injection
  • Prevymis injection must be given through a sterile 0.2 or 0.22 micron polyethersulfone (PES) in-line filter via a peripheral or central venous line
  • Prevymis injection should only be used in patients unable to take oral therapy; switch to oral Prevymis as soon as possible, ideally limiting IV use to no more than 4 weeks
  • Do not use Prevymis injection with IV bags or infusion sets containing the plasticizer DEHP
Available strengths 2 strengths
8 FDA-listed product records ⓘ

Tablet

By mouth
Brands Prevymis
How this form is used
What it may be used for
  • Prevymis tablets are used to prevent CMV infection and disease in eligible stem cell transplant recipients
  • Prevymis tablets are used to prevent CMV disease in eligible high-risk kidney transplant recipients
Important instructions
  • Prevymis tablets may be taken with or without food
  • Prevymis tablets should be swallowed whole — do not crush or chew
  • Prevymis tablets are taken once daily; follow your prescriber's instructions for how long to continue
  • Prevymis tablets are not recommended for pediatric patients weighing less than 7.5 kg
Available strengths 2 strengths
8 FDA-listed product records ⓘ

Other oral form

By mouth
Brands Prevymis
How this form is used
What it may be used for
  • Prevymis oral pellets are used to prevent CMV infection and disease in eligible stem cell transplant recipients, including younger children and those who cannot swallow tablets
  • Prevymis oral pellets are used to prevent CMV disease in eligible high-risk kidney transplant recipients who cannot swallow tablets
Important instructions
  • Prevymis oral pellets should be mixed with soft food or given through a nasogastric (NG) or gastric (G) tube — do not crush or chew the pellets
  • Prevymis oral pellets are taken once daily; follow your prescriber's specific weight-based dosing instructions
  • Follow the Instructions for Use provided with Prevymis oral pellets for correct preparation and administration
  • Prevymis oral pellets are available in 20 mg and 120 mg packet sizes to allow weight-based dosing in pediatric patients
Available strengths 2 strengths
2 FDA-listed product records ⓘ

📊 Letermovir across the U.S. market

How Letermovir 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.

3
Dose forms ⓘ
7
Manufacturers
1
Brand names
21
FDA-listed product records ⓘ
2017
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 (3) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Merck Sharp & Dohme LLC67%
MSD International GmbH10%
Honour Lab Limited5%
MSD Ireland (Carlow)5%
MSN Life Sciences Private Limited5%
Nantong Jinghua Pharmaceutical Co., Ltd5%
Other makers5%

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

📈 How widely Letermovir is used

A general measure of how commonly Letermovir 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 Letermovir 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.

4,462
Medicaid prescriptions filled (Q1–Q4 2025)
$34.3M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Letermovir prescribed? Of the 1,597 medications we measure, Letermovir ranks #1,062 by Medicaid prescriptions — more than 34% of them.

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

Utilization by Letermovir 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 480 mg oral tablet is the most-dispensed Letermovir product — about 96% of these Medicaid prescriptions.

letermovir 480 MG Oral Tablet Most dispensed

4,279 Medicaid prescriptions (Q1–Q4 2025) 96% of Letermovir prescriptions shown $33.1M gross reimbursement (before rebates) ≈ $7,729 per prescription (gross)

Summed across the 2 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1988673

letermovir 240 MG Oral Tablet

140 Medicaid prescriptions (Q1–Q4 2025) 3% of Letermovir prescriptions shown $1.1M gross reimbursement (before rebates) ≈ $7,788 per prescription (gross)

Summed across the 2 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1988666

letermovir 120 MG Oral Pellet

43 Medicaid prescriptions (Q1–Q4 2025) <1% of Letermovir prescriptions shown $168,934 gross reimbursement (before rebates) ≈ $3,929 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2693191

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 Letermovir, 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 5 of 12 listed Letermovir NDCs with Medicaid activity.

🔍 Compare Letermovir products

A representative set of FDA-listed product records for Letermovir — 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.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Injection
1 kg/kg — Honour Lab Limited BULK INGREDIENT View NDC →
20 mg/mL Intravenous Merck Sharp & Dohme LLC × 6 listings NDA View NDC →
20 mg/mL — MSD Ireland (Carlow) DRUG FOR FURTHER PROCESSING View NDC →
💊Other oral form
20 mg Oral Merck Sharp & Dohme LLC NDA View NDC →
120 mg Oral Merck Sharp & Dohme LLC NDA View NDC →
💊Tablet
240 mg Oral Merck Sharp & Dohme LLC × 3 listings NDA View NDC →
480 mg Oral Merck Sharp & Dohme LLC × 3 listings NDA View NDC →
240 mg — MSD International GmbH DRUG FOR FURTHER PROCESSING View NDC →
480 mg — MSD International GmbH DRUG FOR FURTHER PROCESSING View NDC →
💊Bulk drug substance
1 kg/kg — MSN Life Sciences Private Limited BULK INGREDIENT View NDC →
1 kg/kg — Nantong Jinghua Pharmaceutical Co., Ltd BULK INGREDIENT View NDC →
1 kg/kg — Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. BULK INGREDIENT View NDC →

Showing 21 of 21 products — FDA National Drug Code Directory. See every product, package size and price: browse all 21 Letermovir 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) Letermovir RxCUI 1988648 3 dose forms · 6 strengths
  1. Dose form (SCDF) Oral Pellet RxCUI 2693184 In current FDA listings
    Clinical drug / strength (SCD) 20 MG RxCUI 2693185 120 MG RxCUI 2693191
  2. Dose form (SCDF) Oral Tablet RxCUI 1988665 In current FDA listings
    Clinical drug / strength (SCD) 240 MG RxCUI 1988666 480 MG RxCUI 1988673

Look up RxCUI 1988648 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

Prevymis

🏭 Manufacturers & labelers

Merck Sharp & Dohme LLC 14 MSD International GmbH 2 Honour Lab Limited 1 MSD Ireland (Carlow) 1 MSN Life Sciences Private Limited 1 Nantong Jinghua Pharmaceutical Co., Ltd 1 Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. 1

RxNorm drug class

Letermovir belongs to the Cytomegalovirus DNA Terminase Complex Inhibitor class.

Pharmacologic class Cytomegalovirus DNA Terminase Complex Inhibitor
Drug family (ATC) Other antivirals
How it works Cytochrome P450 2C9 Inducers, Cytochrome P450 2C19 Inducers, Cytochrome P450 2C8 Inhibitors, Organic Anion Transporting Polypeptide 1B1 Inhibitors

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 Jan 14, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Letermovir.
📈
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 Letermovir after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
21
Distinct labelers/manufacturers represented
7
Linked representative label ⓘ
Merck Sharp & Dohme LLC
Linked label effective
Jan 14, 2026
Composite sections available
23
Linked SPL Set ID
1b49df80-be4f-47e0-a0b7-123f3e69395b
Linked SPL Document ID
282d792e-e2f2-4744-8526-4d18427c55cb
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 1 FDA-filed SPL label set 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.