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Livtencity MARIBAVIR 200 mg Tablet, Coated, 56-count — NDC 64764-0800-56 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Livtencity MARIBAVIR 200 mg Tablet, Coated, 56-count — NDC 64764-800-56 (Billing 64764-0800-56)

by Takeda Pharmaceuticals America, Inc. · 1 BOTTLE in 1 CARTON / 56 TABLET, COATED in 1 BOTTLE

This is a package of 56 tablets of Livtencity MARIBAVIR 200 mg Tablet, Coated from Takeda Pharmaceuticals America, Inc., marketed since Nov 2021 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 64764-0800-56
🏷️ FDA NDC (as labeled) 64764-800-56 billing pads the product segment with a zero
This package
Contains56-count Medicaid pays$228.13 / unit · 12 mo Per package$12,775.01 / 56 tablets · Medicaid Pack sizes2 compare ↓
Also priced by: Part D plans $235.54/unit — full pricing hub ↓
Main listing for product 64764-800 · Also comes in: 28 tablets 64764-800-28
Rx only Brand 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 →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 64764-800-56 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
64764 labeler · 800 product · 56 package
Package marketed since
Nov 23, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
56 EA per package
Barcode (UPC-A, from the NDC)
3 6476480056 7
Medicaid fills, this package
70 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 64764-800-56
Product NDC 64764-800
11-digit billing NDC 64764080056
NCPDP billing unit EA — each (per item)
RxCUI 2586073, 2586079
UNII PTB4X93HE1
Application # NDA215596
SPL Set ID c94fc2c5-e840-4f18-b7d8-d5eacb26d3a0
Established class (EPC) Cytomegalovirus pUL97 Kinase Inhibitor
Mechanism of action Cytomegalovirus pUL97 Kinase Inhibitors; Cytochrome P450 3A4 Inhibitors; P-Glycoprotein Inhibitors; Breast Cancer Resistance Protein Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-11-23
Route ORAL
Dosage form TABLET, COATED
Substance MARIBAVIR

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

GPI-14 12200050000320
GPI class Livtencity
GCN Seq No 082853
GCN 51574
HICL code 047687
Ingredient (HICL) Maribavir
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W5
Therapeutic class — intermediate (HIC2) Antiviral Agents
HIC3 code W5A
Therapeutic class — specific (HIC3) Antivirals, General
AHFS code 08:18.44.00
AHFS class Cmv Antivirals
FDB label name LIVTENCITY 200 MG TABLET
FDB brand name Livtencity
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 082853
  • GCN: 51574
  • GPI-14 (Medi-Span): 12200050000320
  • HICL (First Databank): 047687
  • AHFS class code: 08:18.44.00
  • RxCUI (RxNorm): 2586073
Why two NDCs? The FDA registers this code as 64764-800-56 — 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 → 64764-0800-56. 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 Cytomegalovirus pUL97 Kinase Inhibitor class.

Pharmacologic class Cytomegalovirus pUL97 Kinase Inhibitor
Drug family (ATC) Other antivirals
How it works Cytochrome P450 3A4 Inhibitors, P-Glycoprotein Inhibitors, Breast Cancer Resistance Protein Inhibitors, Cytomegalovirus pUL97 Kinase 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 LIVTENCITY 200 MG TABLET Ingredient Maribavir
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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $228.13 $12,775.01 / 56 tablets
Medicare drug plans payPart D · Q2 2026 $235.54 $13,190.28 / 56 tablets
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
64764-0800-28 64764-800-28 1 BOTTLE in 1 CARTON / 28 TABLET, COATED in 1 BOTTLE 2021-11-23 — Active
64764-0800-56 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 56 TABLET, COATED in 1 BOTTLE 2021-11-23 — Active

In Medicaid, this is the most-dispensed pack of this product — about 51% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 56-count package — 1 bottle in 1 carton / 56 tablet, coated in 1 bottle.
How does this package differ from NDC 64764-0800-28?
Both are Livtencity MARIBAVIR 200 mg Tablet, Coated — the drug itself is identical. This page's package is the 56-count one, while NDC 64764-0800-28 is the 28 tablets package.
What NDC number is used to bill for this package of Livtencity MARIBAVIR 200 mg Tablet, Coated?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Livtencity 200 mgthis 64764-0800-56 Takeda 56 tablets — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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

🏛️
2021
First FDA approval
Nov 2021
📍
2026
Currently FDA-listed
5 years listed
🛡️
2043
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Oct 2043. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Nov 23, 2021 RLD RS ⏳ ~17 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 12447170 — method of use (U-4328)
US 12447169 — method of use (U-4329)
US 12213989 — method of use (U-4137)
US 12433907 — method of use (U-4289)
US 11684632 — method of use (U-3650)
US 12661368 — method of use (U-4572)
US 12527771 — drug substance
US 12295940 — drug substance
Exclusivity NCE
Exclusivity ODE-388
2021 2023 2025 2027 2029 2031 2033 2035 2037 2039 2041 2043
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (8)
PatentTypeUse codeExpires
US 12447170 ↗ Method of use U-4328 Nov 18, 2042
US 12447169 ↗ Method of use U-4329 Oct 27, 2031
US 12213989 ↗ Method of use U-4137 Nov 18, 2042
US 12433907 ↗ Method of use U-4289 Nov 18, 2042
US 11684632 ↗ Method of use U-3650 Jan 4, 2032
US 12661368 ↗ Method of use U-4572 Oct 27, 2031
US 12527771 ↗ Drug substance — Oct 11, 2043
US 12295940 ↗ Drug substance — Oct 11, 2043
FDA exclusivity
CodeWhat it grantsExpires
NCENew Chemical Entity (5-year)Nov 23, 2026
ODE-388Orphan Drug Exclusivity (7-year)Nov 23, 2028
Common questions
Is there a generic version of LIVTENCITY 200 MG TABLET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for LIVTENCITY 200 MG TABLET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Oct 2043 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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.

What it looks like

Color Blue
ShapeOval
ImprintSHP;620
Size16 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII H8AV0SQX4D
    A modified starch derived from potato or corn starch. It absorbs water quickly and helps tablets or capsules break apart and dissolve in the stomach, acting as a disintegrant to ensure the medicine releases its active ingredients properly.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

8 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
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

LabelerTakeda Pharmaceuticals America, Inc.
Application holderTAKEDA PHARMACEUTICALS USA INC
FDA applicationNDA215596 (NDA)
Labeler code64764
First marketedNov 2021
Product typeHuman Prescription Drug
Portfolio154 products on file

More NDCs from Takeda Pharmaceuticals America, Inc. labeler code 64764

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 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 115 words ▾

1 INDICATIONS AND USAGE LIVTENCITY ® is indicated for the treatment of adults and pediatric patients (12 years of age and older and weighing at least 35 kg) with post-transplant cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet [see Use in Specific Populations (8.4) and Clinical Studies (14) ] . LIVTENCITY is a cytomegalovirus (CMV) pUL97 kinase inhibitor indicated for the treatment of adults and pediatric patients (12 years of age and older and weighing at least 35 kg) with post-transplant CMV infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet.

( 1 , 8.4 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION 400 mg (two 200 mg tablets) orally twice daily with or without food. ( 2.1 , 8.4 )

2.1Recommended Dosage The recommended dosage in adults and pediatric patients (12 years of age and older and weighing at least 35 kg) is 400 mg (two 200 mg tablets) taken orally twice daily with or without food [see Use in Specific Populations (8.4) , Clinical Pharmacology (12.3) and Clinical Studies (14) ] .

2.2Dosage Adjustment When Coadministered with Anticonvulsants If LIVTENCITY is coadministered with carbamazepine, increase the dosage of LIVTENCITY to 800 mg (four 200 mg tablets) twice daily [see Drug Interactions (7.3) and Clinical Pharmacology (12.3) ] . If LIVTENCITY is coadministered with phenytoin or phenobarbital, increase the dosage of LIVTENCITY to 1,200 mg (six 200 mg tablets) twice daily [see Drug Interactions (7.3) and Clinical Pharmacology (12.3) ] .

2.3Dosage Adjustment When Coadministered with Rifabutin If LIVTENCITY is co-administered with rifabutin, increase the dosage of LIVTENCITY to 800 mg (four 200 mg tablets) twice daily [see Drug Interactions (7.3) and Clinical Pharmacology (12.3) ] .

2.4Administration Instructions The immediate-release tablets can be taken as whole, dispersed or crushed tablets by mouth, or as dispersed tablets through a nasogastric or orogastric tube (French size 10 or larger). The suspension may be prepared ahead of time and stored at room temperature for up to 8 hours. Administration of Dispersed Tablets or Crushed Tablets by Mouth Place the appropriate number of tablets for the prescribed dose into a suitable container.

If desired, the tablets may be crushed. Add the appropriate volume of drinking water (other liquids have not been tested) to make a suspension (see Table 1 below) . Table 1: Number of Tablets and Volume of Drinking Water Needed to Make a Suspension for Administration of Dispersed or Crushed Tablets by Mouth Recommended Dosage Number of 200 mg Tablets Volume of Drinking Water 400 mg Two 30 mL 800 mg Four 60 mL 1,200 mg Six 90 mL Swirl the container gently to keep the particles from settling, and administer the suspension before it settles.

The mixture will have a bitter taste. Rinse the container with 15 mL of drinking water and administer the rinse water. Repeat Step 3.

Visually confirm that no particles are left in the container. If particles remain, repeat Step 3. Administration of Dispersed Tablets through a Nasogastric (NG) or Orogastric (OG) Tube Remove the cap (if applicable) and plunger out of a 50 or 60 mL catheter-tip compatible syringe or equivalent.

Add two tablets into the syringe body and place the plunger back in the syringe. Only two tablets can be administered via NG or OG tube at a time. Draw 30 mL of drinking water (other liquids have not been tested) into the syringe and hold the syringe with the tip pointing upward.

Pull the plunger further to a higher volume position to have some air space in the syringe. Place the cap back on the syringe (if applicable). Shake the syringe well (careful not to spill the contents) for about 30 to 45 seconds or until the tablets are completely dispersed.

Once the tablets are completely dispersed in the syringe, remove the cap from the syringe again (if applicable) and attach the syringe to the NG or OG tube and administer the dispersion before it settles. Draw 15 mL of water using the same syringe and flush through the same NG or OG tube. Repeat Step 4 and make sure no particles are left in the syringe by visual inspection.

If particles remain, repeat Step 4. For doses of 800 mg (four 200 mg tablets) and 1,200 mg (six 200 mg tablets) [see Dosage and Administration (2.2 , 2.3) ] , repeat Steps 1-5 until prescribed dose is reached. The same syringe, NG or OG tube can be used.

💊 Dosage Forms and Strengths 33 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablet: 200 mg, blue, oval shaped convex tablet debossed with "SHP" on one side and "620" on the other side. Tablets: 200 mg of maribavir. ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS LIVTENCITY may antagonize the antiviral activity of ganciclovir and valganciclovir. Coadministration is not recommended. ( 5.1 , 7.1 ) Virologic failure can occur during and after treatment with LIVTENCITY.

Monitor CMV DNA levels and check for resistance if patient does not respond to treatment. Some maribavir pUL97 resistance-associated substitutions confer cross-resistance to ganciclovir and valganciclovir. ( 5.2 , 12.4 , 14.1 ) The concomitant use of LIVTENCITY and certain drugs may result in potentially significant drug interactions, some of which may lead to reduced therapeutic effect of LIVTENCITY or adverse reactions of concomitant drugs.

( 5.1 , 5.3 , 7.1 , 7.2 , 7.3 ) LIVTENCITY has the potential to increase the drug concentrations of certain immunosuppressant drugs where minimal concentration changes may lead to serious adverse events (including tacrolimus, cyclosporine, sirolimus and everolimus). Frequently monitor immunosuppressant drug levels throughout treatment with LIVTENCITY, especially following initiation and after discontinuation of LIVTENCITY and adjust the dose, as needed. ( 5.3 )

5.1Risk of Reduced Antiviral Activity When Coadministered with Ganciclovir and Valganciclovir LIVTENCITY may antagonize the antiviral activity of ganciclovir and valganciclovir by inhibiting human CMV pUL97 kinase, which is required for activation/phosphorylation of ganciclovir and valganciclovir. Coadministration of LIVTENCITY with ganciclovir or valganciclovir is not recommended [see Drug Interactions (7.1) and Microbiology (12.4) ] .

5.2Virologic Failure During Treatment and Relapse Post-Treatment Virologic failure due to resistance can occur during and after treatment with LIVTENCITY. Virologic relapse during the post-treatment period usually occurred within 4-8 weeks after treatment discontinuation. Some maribavir pUL97 resistance-associated substitutions confer cross-resistance to ganciclovir and valganciclovir.

Monitor CMV DNA levels and check for maribavir resistance if the patient is not responding to treatment or relapses [see Microbiology (12.4) and Clinical Studies (14.1) ] .

5.3Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions The concomitant use of LIVTENCITY and certain drugs may result in potentially significant drug interactions, some of which may lead to reduced therapeutic effect of LIVTENCITY or adverse reactions of concomitant drugs [see Drug Interactions (7) ] . See Table 4 for steps to prevent or manage these possible or known significant drug interactions, including dosing recommendations. Consider the potential for drug interactions prior to and during LIVTENCITY therapy; review concomitant medications during LIVTENCITY therapy and monitor for adverse reactions.

Maribavir is primarily metabolized by CYP3A4. Drugs that are strong inducers of CYP3A4 are expected to decrease maribavir plasma concentrations and may result in reduced virologic response. Thus, coadministration of LIVTENCITY with these drugs is not recommended, except with a dose adjustment when coadministered with selected anticonvulsants (carbamazepine and phenytoin).

With moderate CYP3A4 inducers rifabutin (antimycobacterial) and phenobarbital (anticonvulsant), a dose adjustment is recommended [see Dosage and Administration (2.2 , 2.3) and Drug Interactions (7.3) ] . For other moderate CYP3A4 inducers, the appropriate maribavir dose adjustment has not been determined. Use with Immunosuppressant Drugs LIVTENCITY has the potential to increase the drug concentrations of certain immunosuppressant drugs where minimal concentration changes may lead to serious adverse events (including tacrolimus, cyclosporine, sirolimus and everolimus).

Frequently monitor immunosuppressant drug levels throughout treatment with LIVTENCITY, especially following initiation and after discontinuation of LIVTENCITY and adjust the immunosuppressant dose, as needed [see Drug Interactions (7.3) and Clinical Pharm… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The most common adverse events (all grades, >10%) in subjects treated with LIVTENCITY were taste disturbance, nausea, diarrhea, vomiting, and fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals America, Inc. at 1-877-TAKEDA-7 (1-877-825-3327) 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 the 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. The safety of LIVTENCITY was evaluated in one Phase 3 multicenter, randomized, open-label, active-control trial in which 352 adult transplant recipients were randomized, and treated with LIVTENCITY (N=234) or Investigator-Assigned Treatment (IAT) consisting of monotherapy or dual therapy with ganciclovir, valganciclovir, foscarnet, or cidofovir as dosed by the investigator (N=116) for up to 8-weeks following a diagnosis of CMV infection/disease refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, foscarnet or cidofovir.

The mean treatment durations (SD) for LIVTENCITY and IAT were 48.6 (± 13.82) and 31.2 (± 16.91) days, respectively. The most common adverse events occurring in more than 10% of subjects receiving LIVTENCITY are outlined in Table 2. Table 2: Adverse Events (All Grades) Reported in >10% of Subjects in the LIVTENCITY Group in Trial 303 ADVERSE EVENT LIVTENCITY N=234 (%) IAT IAT (Investigator-Assigned Treatment) included monotherapy or dual therapy with ganciclovir, valganciclovir, foscarnet, or cidofovir as dosed by the investigator.

N=116 (%) Taste disturbance taste disturbance includes the following reported preferred terms: ageusia, dysgeusia, hypogeusia and taste disorder. 46 4 Nausea 21 22 Diarrhea 19 21 Vomiting 14 16 Fatigue 12 9 Similar proportions of subjects experienced serious adverse events (38% in the LIVTENCITY group and 37% in the IAT group). The most common serious adverse event in both treatment groups occurred in the Infections and Infestations System Organ Class (SOC) (23% in the LIVTENCITY group and 15% in the IAT group) with CMV infection and disease being the most common in both groups.

A higher proportion of subjects in the IAT group discontinued study medication due to an adverse event compared to the LIVTENCITY group (32% in the IAT group vs 13% in the LIVTENCITY group). The most commonly reported causes that led to study drug discontinuation were neutropenia (9%) and acute kidney injury (5%) in the IAT group and dysgeusia, diarrhea, nausea, and recurrence of underlying disease (each reported at 1%) in the LIVTENCITY group. Taste disturbance occurred in 46% of subjects treated with LIVTENCITY.

These events rarely led to discontinuation of LIVTENCITY (1%) and, for 37% of the subjects, these events resolved while on therapy (median duration 43 days; range 7 to 59 days). For the subjects with ongoing taste disturbance after drug discontinuation, resolution occurred in 89%. In subjects with resolution of symptoms after drug discontinuation, the median duration of symptoms off treatment was 6 days (range 2 to 85 days).

Laboratory Abnormalities Selected laboratory abnormalities reported in subjects with refractory (with or without genotypic resistance) CMV infections in Trial 303 are presented in Table 3. Table 3: Selected Laboratory Abnormalities Reported in Trial 303 Laboratory Parameter LIVTENCITY N=234 n (%) IAT N=116 n (%) Neutrophils (cells/µL) <500 4 (2) 4 (3) ≥500 to <750 7 (3) 7 (6) ≥750 to <1,000 10 (4) 6 (5) Hemoglobin (g/dL) <6.5 3 (1) 1 (1) ≥6.5 to <8.0 34 (15) 23 (20) ≥8.0 to <9.5 76 (32) 33 (28) Platelets (cells/µL) <25,000 11 (5) 6 (5) ≥25,000 to <50,000 27 (12) 10 (9) ≥50,000 to <100,000 41 (18) 20 (17) Creatinine (mg/dL) >2.5 16 (7) 12 (10) >1.5 to ≤2.5 78 (33) 29 (25)

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS Refer to the full prescribing information for important drug interactions with LIVTENCITY. ( 5.1 , 5.3 , 7 ) Coadministration with strong CYP3A4 inducers is not recommended, except with a dose adjustment when coadministered with selected anticonvulsants (carbamazepine and phenytoin). When coadministered with the moderate CYP3A4 inducers rifabutin (antimycobacterial) or phenobarbital (anticonvulsant), a dose adjustment is recommended.

( 2.2 , 2.3 , 7.3 )

7.1Reduced Antiviral Activity When Coadministered with Ganciclovir or Valganciclovir LIVTENCITY is not recommended to be coadministered with valganciclovir/ganciclovir (vGCV/GCV). LIVTENCITY may antagonize the antiviral activity of ganciclovir and valganciclovir by inhibiting human CMV pUL97 kinase, which is required for activation/phosphorylation of ganciclovir and valganciclovir [see Warnings and Precautions (5.1) and Microbiology (12.4) ] .

7.2Potential for Other Drugs to Affect LIVTENCITY Maribavir is a substrate of CYP3A4. Coadministration of LIVTENCITY with strong inducers of CYP3A4 is not recommended, except with a dose adjustment when coadministered with selected anticonvulsants (carbamazepine and phenytoin). With the moderate CYP3A4 inducers, rifabutin (antimycobacterial) and phenobarbital (anticonvulsant), a dose adjustment is recommended [see Dosage and Administration (2.2 , 2.3) and Drug Interactions (7.3) ] .

For other moderate CYP3A4 inducers, the appropriate maribavir dose adjustment has not been determined.

7.3Potential for LIVTENCITY to Affect Other Drugs Maribavir is an inhibitor of P-gp and breast cancer resistance protein (BCRP). Coadministration of LIVTENCITY with drugs that are substrates of P-gp and/or BCRP where minimal concentration changes may lead to serious adverse events may result in a clinically relevant increase in plasma concentrations of these substrates (see Table 4 ) . Table 4 provides a list of established or potentially clinically significant drug interactions, based on either clinical drug interaction studies or predicted interactions due to the expected magnitude of interaction and potential for serious adverse events or decrease in efficacy [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3) ] .

Table 4: Established and Other Potentially Significant Drug Interactions This table is not all inclusive. Concomitant Drug Class: Drug Name Effect on Concentration Clinical Comments ↓=decrease, ↑=increase. Antiarrhythmics Digoxin The interaction between LIVTENCITY and the concomitant drug was evaluated in a clinical study [see Clinical Pharmacology (12.3) ] . ↑ Digoxin Use caution when LIVTENCITY and digoxin are coadministered.

Monitor serum digoxin concentrations. The dose of digoxin may need to be reduced when coadministered with LIVTENCITY. Refer to the respective prescribing information.

Anticonvulsants Carbamazepine ↓ Maribavir A dose adjustment of LIVTENCITY to 800 mg twice daily is recommended when coadministered with carbamazepine. Phenobarbital ↓ Maribavir A dose adjustment of LIVTENCITY to 1,200 mg twice daily is recommended when coadministration with phenobarbital. Phenytoin ↓ Maribavir A dose adjustment of LIVTENCITY to 1,200 mg twice daily is recommended when coadministration with phenytoin.

Antimycobacterials Rifabutin ↓ Maribavir A dose adjustment of LIVTENCITY to 800 mg twice daily is recommended when coadministered with rifabutin. Rifampin ↓ Maribavir Coadministration of LIVTENCITY and rifampin is not recommended due to potential for a decrease in efficacy of LIVTENCITY. Herbal Products St.

John's wort ↓ Maribavir Coadministration of LIVTENCITY and St. John's wort is not recommended due to potential for a decrease in efficacy of LIVTENCITY. HMG-CoA Reductase Inhibitors Rosuvastatin ↑ Rosuvastatin The patient should be closely monitored for rosuvastatin-related events, especially the occurrence of myopathy and rhabdomyolysis.

Immunosuppressants Cyclosporine ↑ Cyclosporine Frequently monitor… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary No adequate human data are available to establish whether LIVTENCITY poses a risk to pregnancy outcomes. In animal reproduction studies, embryo-fetal survival was decreased in rats, but not in rabbits, at maribavir exposures less than those observed in humans at the recommended human dose (RHD) (see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In a combined fertility and embryofetal development study, maribavir was administered to male and female rats at oral doses of 100, 200, or 400 mg/kg/day. Females were dosed for 15 consecutive days prior to pairing, throughout pairing, and up to gestation day (GD) 17, while males were dosed 29 days prior to mating and throughout mating.

A decrease in the number of viable fetuses and increase in early resorptions and post-implantation losses were observed at ≥100 mg/kg/day (at exposures approximately half the human exposure at the RHD). Intermittent reduced body weight gain was observed in pregnant animals at ≥200 mg/kg/day. Maribavir had no effect on embryo-fetal growth or development at dose levels up to 400 mg/kg/day, at exposures similar to those observed in humans at the RHD.

No significant toxicological effects on embryo-fetal growth or development were observed in rabbits when maribavir was administered at oral doses up to 100 mg/kg/day from GD 8 to 20, at exposures approximately half the human exposure at the RHD. In the pre-and post-natal developmental toxicity study, maribavir was administered to pregnant rats at oral doses of 50, 150, or 400 mg/kg/day from GD 7 to post-natal day (PND) 21. A delay in developmental milestones was observed, including pinna detachment at doses ≥150 mg/kg/day and eye opening and preputial separation associated with reduced bodyweight gain of the offspring at 400 mg/kg/day.

In addition, decreased fetal survival and litter loss was observed due to maternal toxicity and poor maternal care, respectively, at doses ≥150 mg/kg/day. No effects were observed at 50 mg/kg/day (which is estimated to be less than the human exposure at the RHD). No effects on number of offspring, proportion of males, number of live pups, or survival to PND 4 were observed at any dose in the offspring born to the second generation.

8.2Lactation Risk Summary It is not known whether maribavir or its metabolites are present in human or animal milk, affect milk production, or have effects on the breastfed infant. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for LIVTENCITY and any potential adverse effects to the breast-fed child.

8.4Pediatric Use The recommended dosing regimen in pediatric patients 12 years of age and older and weighing at least 35 kg is the same as that in adults. Use of LIVTENCITY in this age group is based on the following: Evidence from controlled studies of LIVTENCITY in adults Population pharmacokinetic (PK) modeling and simulation demonstrating that age and body weight had no clinically meaningful effect on plasma exposures of LIVTENCITY LIVTENCITY exposure is expected to be similar between adults and children 12 years of age and older and weighing at least 35 kg The course of the disease is similar between adults and pediatric patients to allow extrapolation of data in adults to pediatric patients [see Dosage and Administration (2.1) , Clinical Pharmacology (12.3) and Clinical Studies (14) ] The safety and effectiveness of LIVTENCITY have not been established in children younger than 12 years of age.

8.5Geriatric Use No dosage adjustment is required for patients over 65 years of age based on the results from population pharmacokinetics analysis [see Clinical Pharmacology (12.3) ] and e… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary No adequate human data are available to establish whether LIVTENCITY poses a risk to pregnancy outcomes. In animal reproduction studies, embryo-fetal survival was decreased in rats, but not in rabbits, at maribavir exposures less than those observed in humans at the recommended human dose (RHD) (see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In a combined fertility and embryofetal development study, maribavir was administered to male and female rats at oral doses of 100, 200, or 400 mg/kg/day. Females were dosed for 15 consecutive days prior to pairing, throughout pairing, and up to gestation day (GD) 17, while males were dosed 29 days prior to mating and throughout mating.

A decrease in the number of viable fetuses and increase in early resorptions and post-implantation losses were observed at ≥100 mg/kg/day (at exposures approximately half the human exposure at the RHD). Intermittent reduced body weight gain was observed in pregnant animals at ≥200 mg/kg/day. Maribavir had no effect on embryo-fetal growth or development at dose levels up to 400 mg/kg/day, at exposures similar to those observed in humans at the RHD.

No significant toxicological effects on embryo-fetal growth or development were observed in rabbits when maribavir was administered at oral doses up to 100 mg/kg/day from GD 8 to 20, at exposures approximately half the human exposure at the RHD. In the pre-and post-natal developmental toxicity study, maribavir was administered to pregnant rats at oral doses of 50, 150, or 400 mg/kg/day from GD 7 to post-natal day (PND) 21. A delay in developmental milestones was observed, including pinna detachment at doses ≥150 mg/kg/day and eye opening and preputial separation associated with reduced bodyweight gain of the offspring at 400 mg/kg/day.

In addition, decreased fetal survival and litter loss was observed due to maternal toxicity and poor maternal care, respectively, at doses ≥150 mg/kg/day. No effects were observed at 50 mg/kg/day (which is estimated to be less than the human exposure at the RHD). No effects on number of offspring, proportion of males, number of live pups, or survival to PND 4 were observed at any dose in the offspring born to the second generation.

🧒 Pediatric Use 148 words ▾

8.4Pediatric Use The recommended dosing regimen in pediatric patients 12 years of age and older and weighing at least 35 kg is the same as that in adults. Use of LIVTENCITY in this age group is based on the following: Evidence from controlled studies of LIVTENCITY in adults Population pharmacokinetic (PK) modeling and simulation demonstrating that age and body weight had no clinically meaningful effect on plasma exposures of LIVTENCITY LIVTENCITY exposure is expected to be similar between adults and children 12 years of age and older and weighing at least 35 kg The course of the disease is similar between adults and pediatric patients to allow extrapolation of data in adults to pediatric patients [see Dosage and Administration (2.1) , Clinical Pharmacology (12.3) and Clinical Studies (14) ] The safety and effectiveness of LIVTENCITY have not been established in children younger than 12 years of age.

🧓 Geriatric Use 69 words ▾

8.5Geriatric Use No dosage adjustment is required for patients over 65 years of age based on the results from population pharmacokinetics analysis [see Clinical Pharmacology (12.3) ] and efficacy and safety data from the clinical studies. In the clinical Study 303, 54 patients aged 65 years and over were treated with LIVTENCITY. Safety, effectiveness, and pharmacokinetics were consistent between elderly patients (≥65 years) and younger patients (<65 years).

🆘 Overdosage 49 words ▾

10 OVERDOSAGE There is no known specific antidote for LIVTENCITY. In case of overdose, it is recommended that the patient be monitored for adverse reactions and appropriate symptomatic treatment instituted. Due to the high plasma protein binding of LIVTENCITY, dialysis is unlikely to reduce plasma concentrations of LIVTENCITY significantly.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action LIVTENCITY is an antiviral drug against human CMV [see Microbiology (12.4) ] .

12.2Pharmacodynamics Exposure-Response In dose-ranging studies that evaluated doses of 400 mg twice daily and twice daily doses of two and three times the recommended dose, no exposure-response relationship was observed for viral load or probability of unquantifiable plasma CMV DNA. In Phase 3 Trial 303 that evaluated a maribavir dose of 400 mg twice daily, increasing maribavir exposure was not associated with increased probability of confirmed plasma CMV DNA < LLOQ (lower limit of quantification) at Week 8. Cardiac Electrophysiology At three times the recommended dose (approximately twice the peak concentration observed following the recommended dose), LIVTENCITY does not prolong the QT interval to any clinically relevant extent.

12.3Pharmacokinetics LIVTENCITY pharmacological activity is due to the parent drug. Following oral administration, plasma maribavir exposure (C max and AUC) increased approximately dose-proportionally following a single dose of 50 to 1600 mg (0.125 to four times the recommended dose) and multiple doses up to 2400 mg per day (three times the recommended daily dose). Maribavir PK is time-independent.

With twice-daily dosing, steady state is reached within 2 days, with mean accumulation ratios of C max and AUC ranging from 1.37 to 1.47. The pharmacokinetic properties of maribavir following administration of LIVTENCITY are displayed in Table 5. The multiple-dose pharmacokinetic parameters are provided in Table 6.

Table 5: Pharmacokinetic Properties of Maribavir Absorption When taken orally with a high fat, high caloric meal vs fasted, the AUC 0‑∞ and C max (geometric mean ratio [90% CI] of maribavir are 0.878 [0.843, 0.915] and 0.716 [0.671, 0.764], respectively. T max (h), median 1.0 to

3.0Distribution Mean apparent steady-state volume of distribution (V ss , L) 24.9 % bound to human plasma proteins 98.0 across the concentration range of 0.05-200 µg/mL Blood-to plasma ratio

1.37Elimination Major route of elimination Hepatic metabolism Half-life (t 1/2 ) in transplant patients (h), mean

4.32 Oral clearance (CL/F) in transplant patients (L/h), mean

2.67Metabolism Metabolic pathways In vitro studies have shown that maribavir is biotransformed into a major circulating inactive metabolite: VP 44469 (N-dealkylated metabolite), with a metabolic ratio of 0.15 - 0.20. Multiple UGT enzymes, namely UGT1A1, UGT1A3, UGT2B7, and possibly UGT1A9, are involved in the glucuronidation of maribavir in humans, however, the contribution of glucuronidation to the overall clearance of maribavir is low based on In vitro data. CYP3A4 (major) and CYP1A2 (minor) Excretion % of dose excreted as total 14 C (unchanged drug) in urine Dosing in mass balance study: single-dose administration of [ 14 C] maribavir oral solution 400 mg containing 200 nCi of total radioactivity.

61 (<2) % of dose excreted as total 14 C (unchanged drug) in feces 14 (5.7) Table 6: Multiple-Dose Pharmacokinetic Parameters of Maribavir Geometric Mean (% CV) Pharmacokinetic parameter values based on post-hoc estimates from maribavir population pharmacokinetic model in transplant patients with CMV receiving 400 mg of LIVTENCITY twice daily with or without food. AUC 0-tau tau is maribavir dosing interval: 12 hours. (µg∙h/mL) C max (µg/mL) C tau (µg/mL) CV=Coefficient of Variation; C max =Maximum concentration; AUC 0-tau =Area under the time concentration curve over a dosing interval; C tau =Concentration at the end of a dosing interval.

142 (48.5%) 20.1 (35.5%) 5.43 (85.9%) Specific Populations There were no clinically significant differences in the pharmacokinetics of maribavir based on age (18-79 years), gender, race (Caucasian, Black, Asian, or others), ethnicity (Hispanic/Latino or non-Hispanic/Latino), body weight (36 to 141 kg), transplant type, mild to severe renal impairment (measured creatinine clearance ranging from 12 to… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 17 words ▾

12.1Mechanism of Action LIVTENCITY is an antiviral drug against human CMV [see Microbiology (12.4) ] .

📦 How Supplied / Storage and Handling 75 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Tablet: 200 mg, blue, oval shaped convex tablet debossed with "SHP" on one side and "620" on the other side. They are supplied as follows: Bottles of 28 tablets with child-resistant caps (NDC 64764-800-28) Bottles of 56 tablets with child-resistant caps (NDC 64764-800-56) Storage and Handling Store at 20°C to 25°C (68°F to 77°F), brief exposure to 15°C to 30°C (59°F to 86°F) permitted [see USP Controlled Room Temperature] .

📦 Storage and Handling 27 words ▾

Storage and Handling Store at 20°C to 25°C (68°F to 77°F), brief exposure to 15°C to 30°C (59°F to 86°F) permitted [see USP Controlled Room Temperature] .

📋 Description 88 words ▾

11 DESCRIPTION LIVTENCITY tablets contain maribavir, a benzimidazole riboside CMV pUL97 protein kinase inhibitor. The chemical name of maribavir is 5,6-Dichloro- N -(1-methylethyl)-1-β-L-ribofuranosyl-1 H -benzimidazol-2-amine and the structural formula is: The molecular formula for maribavir is C 15 H 19 Cl 2 N 3 O 4 and its molecular weight is 376.23. Each 200 mg tablet for oral administration contains 200 mg maribavir and the following inactive ingredients: FD&C Blue #1, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, titanium dioxide, and talc.

Chemical Structure

💬 Information for Patients 55 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Inform patients that LIVTENCITY may interact with other drugs. Advise patients to report to their healthcare provider the use of any other medication [see Warnings and Precautions (5.1 and 5.3) , Drug Interactions (7) ] .

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics LIVTENCITY pharmacological activity is due to the parent drug. Following oral administration, plasma maribavir exposure (C max and AUC) increased approximately dose-proportionally following a single dose of 50 to 1600 mg (0.125 to four times the recommended dose) and multiple doses up to 2400 mg per day (three times the recommended daily dose). Maribavir PK is time-independent.

With twice-daily dosing, steady state is reached within 2 days, with mean accumulation ratios of C max and AUC ranging from 1.37 to 1.47. The pharmacokinetic properties of maribavir following administration of LIVTENCITY are displayed in Table 5. The multiple-dose pharmacokinetic parameters are provided in Table 6.

Table 5: Pharmacokinetic Properties of Maribavir Absorption When taken orally with a high fat, high caloric meal vs fasted, the AUC 0‑∞ and C max (geometric mean ratio [90% CI] of maribavir are 0.878 [0.843, 0.915] and 0.716 [0.671, 0.764], respectively. T max (h), median 1.0 to

3.0Distribution Mean apparent steady-state volume of distribution (V ss , L) 24.9 % bound to human plasma proteins 98.0 across the concentration range of 0.05-200 µg/mL Blood-to plasma ratio

1.37Elimination Major route of elimination Hepatic metabolism Half-life (t 1/2 ) in transplant patients (h), mean

4.32 Oral clearance (CL/F) in transplant patients (L/h), mean

2.67Metabolism Metabolic pathways In vitro studies have shown that maribavir is biotransformed into a major circulating inactive metabolite: VP 44469 (N-dealkylated metabolite), with a metabolic ratio of 0.15 - 0.20. Multiple UGT enzymes, namely UGT1A1, UGT1A3, UGT2B7, and possibly UGT1A9, are involved in the glucuronidation of maribavir in humans, however, the contribution of glucuronidation to the overall clearance of maribavir is low based on In vitro data. CYP3A4 (major) and CYP1A2 (minor) Excretion % of dose excreted as total 14 C (unchanged drug) in urine Dosing in mass balance study: single-dose administration of [ 14 C] maribavir oral solution 400 mg containing 200 nCi of total radioactivity.

61 (<2) % of dose excreted as total 14 C (unchanged drug) in feces 14 (5.7) Table 6: Multiple-Dose Pharmacokinetic Parameters of Maribavir Geometric Mean (% CV) Pharmacokinetic parameter values based on post-hoc estimates from maribavir population pharmacokinetic model in transplant patients with CMV receiving 400 mg of LIVTENCITY twice daily with or without food. AUC 0-tau tau is maribavir dosing interval: 12 hours. (µg∙h/mL) C max (µg/mL) C tau (µg/mL) CV=Coefficient of Variation; C max =Maximum concentration; AUC 0-tau =Area under the time concentration curve over a dosing interval; C tau =Concentration at the end of a dosing interval.

142 (48.5%) 20.1 (35.5%) 5.43 (85.9%) Specific Populations There were no clinically significant differences in the pharmacokinetics of maribavir based on age (18-79 years), gender, race (Caucasian, Black, Asian, or others), ethnicity (Hispanic/Latino or non-Hispanic/Latino), body weight (36 to 141 kg), transplant type, mild to severe renal impairment (measured creatinine clearance ranging from 12 to 70 mL/min), or mild to moderate hepatic impairment (Child-Pugh Class A or B). Pediatric Patients The pharmacokinetics of maribavir in patients less than 18 years of age have not been evaluated.

Using modeling and simulation, the recommended dosing regimen is expected to result in comparable steady-state plasma exposures of maribavir in patients 12 years of age and older and weighing at least 35 kg as observed in adults [see Use in Specific Populations (8.4) ] . Drug Interactions Based on in vitro studies, the metabolism of maribavir is not mediated by CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A5, UGT1A4, UGT1A6, UGT1A10, or UGT2B15. The transport of maribavir is not mediated by organic anion transporting polypeptide (OATP)1B1, OATP1B3, or bile salt export pump (BSEP).

At clinically relevant concentrations, clinically significant interactions are not expected when… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 109 words ▾

12.2Pharmacodynamics Exposure-Response In dose-ranging studies that evaluated doses of 400 mg twice daily and twice daily doses of two and three times the recommended dose, no exposure-response relationship was observed for viral load or probability of unquantifiable plasma CMV DNA. In Phase 3 Trial 303 that evaluated a maribavir dose of 400 mg twice daily, increasing maribavir exposure was not associated with increased probability of confirmed plasma CMV DNA < LLOQ (lower limit of quantification) at Week 8. Cardiac Electrophysiology At three times the recommended dose (approximately twice the peak concentration observed following the recommended dose), LIVTENCITY does not prolong the QT interval to any clinically relevant extent.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Treatment of Adults with Post-Transplant CMV Infection/Disease That Is Refractory (with or without Genotypic Resistance) to Ganciclovir, Valganciclovir, Cidofovir, or Foscarnet LIVTENCITY was evaluated in a Phase 3, multicenter, randomized, open-label, active-controlled superiority trial (NCT02931539, Trial 303) to assess the efficacy and safety of LIVTENCITY compared to Investigator-Assigned Treatment (IAT) (ganciclovir, valganciclovir, foscarnet, or cidofovir) in 352 HSCT or SOT recipients with CMV infections that were refractory to treatment with ganciclovir, valganciclovir, foscarnet, or cidofovir, including CMV infections with or without confirmed resistance to 1 or more of the IATs.

Subjects with CMV disease involving the central nervous system, including the retina, were excluded from the study. Subjects were stratified by transplant type (HSCT or SOT) and screening CMV DNA levels and then randomized in a 2:1 allocation ratio to receive either LIVTENCITY 400 mg twice daily or IAT as dosed by the investigator for up to 8 weeks. After completion of the treatment period, subjects entered a 12-week follow-up phase.

The mean age of trial subjects was 53 years and most subjects were male (61%), white (76%) and not Hispanic or Latino (83%), with similar distributions across the two treatment arms. The most common treatment used in the IAT arm was foscarnet which was administered in 47 (41%) subjects followed by ganciclovir or valganciclovir, each administered in 28 (24%) subjects. Cidofovir was administered in 6 subjects, the combination of foscarnet and valganciclovir in 4 subjects and the combination of foscarnet and ganciclovir in 3 subjects.

Baseline disease characteristics are summarized in Table 9 below. Table 9: Summary of Baseline Disease Characteristics in Trial 303 Characteristic LIVTENCITY 400 mg Twice Daily N=235 n (%) IAT N=117 n (%) CMV=cytomegalovirus, DNA=deoxyribonucleic acid, HSCT=hematopoietic stem cell transplant, IAT=investigator assigned anti-CMV treatment, N=number of patients, SOT=solid organ transplant. Transplant type HSCT 93 (40) 48 (41) SOT 142 (60) 69 (59) Kidney 74 (52) 32 (46) Lung 40 (28) 22 (32) Heart 14 (10) 9 (13) Other (multiple, liver, pancreas, intestine) 14 (10) 6 (9) CMV DNA levels Low (<9,100 IU/mL) 153 (65) 85 (73) Intermediate (≥9,100 to <91,000 IU/mL) 68 (29) 25 (21) High (≥91,000 IU/mL) 14 (6) 7 (6) Confirmed symptomatic CMV infection at baseline No 214 (91) 109 (93) Yes one of the subjects had both CMV syndrome and disease but was counted for CMV disease only.

21 (9) 8 (7) CMV syndrome (SOT only) 9 (43) 7 (88) Tissue Invasive disease 12 (57) 1 (13) Primary Efficacy Endpoint The primary efficacy endpoint was confirmed CMV DNA level < LLOQ (i.e., <137 IU/mL) as assessed by COBAS ® AmpliPrep/COBAS ® TaqMan ® CMV test) at the end of Week 8. The key secondary endpoint was CMV DNA level < LLOQ and CMV infection symptom control at the end of Study Week 8 with maintenance of this treatment effect through Study Week 16. For the primary endpoint, LIVTENCITY was statistically superior to IAT (56% vs 24%, respectively), as shown in Table 10.

Table 10: Primary Efficacy Endpoint Analysis at Week 8 (Randomized Set) in Trial 303 LIVTENCITY 400 mg Twice Daily N=235 n (%) IAT N=117 n (%) CI=confidence interval; CMV=cytomegalovirus; IAT=investigator-assigned anti-CMV treatment; N=number of patients. Primary Endpoint: Confirmed CMV DNA Level < LLOQ at Week 8 Confirmed CMV DNA level < LLOQ at the end of Week 8 (2 consecutive samples separated by at least 5 days with DNA levels < LLOQ [i.e.:, <137 IU/mL]). Responders 131 (56) 28 (24) Adjusted difference in proportion of responders (95% CI) Cochran-Mantel-Haenszel weighted average approach was used for the adjusted difference in proportion (maribavir – IAT), the corresponding 95% CI, and the p-value after adjusting for the transplant type and baseline plasma CMV DNA concentration.

Only those with both stratification factors were… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 200 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Two-year carcinogenicity studies were conducted in mice and rats administered oral doses up to 150 and 100 mg/kg/day, respectively. Maribavir was not carcinogenic in rats at any dose tested, corresponding to maribavir exposures less than human exposure at the RHD. At 150 mg/kg/day in male mice only, an increased incidence of hemangioma, hemangiosarcoma, and combined hemangioma/hemangiosarcoma was observed across multiple tissues, at exposures less than the human exposure at the RHD.

There were no carcinogenic findings in male mice at ≤75 mg/kg/day and female mice at any dose. Mutagenicity Maribavir was negative in a bacterial mutation assay and the in vivo rat bone marrow micronucleus assay. Maribavir was positive in the absence of metabolic activation in the mouse lymphoma assay, and the results were equivocal in the presence of metabolic activation.

Impairment of Fertility Although decreased sperm straight line velocity was observed in males (at maribavir exposures less than those observed in humans at the RHD), there were no effects on fertility in males or females in a combined oral fertility and embryo-fetal study in rats administered maribavir at up to 400 mg/kg/day [see Use in Specific Populations (8.1) ] .

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 197 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Two-year carcinogenicity studies were conducted in mice and rats administered oral doses up to 150 and 100 mg/kg/day, respectively. Maribavir was not carcinogenic in rats at any dose tested, corresponding to maribavir exposures less than human exposure at the RHD. At 150 mg/kg/day in male mice only, an increased incidence of hemangioma, hemangiosarcoma, and combined hemangioma/hemangiosarcoma was observed across multiple tissues, at exposures less than the human exposure at the RHD.

There were no carcinogenic findings in male mice at ≤75 mg/kg/day and female mice at any dose. Mutagenicity Maribavir was negative in a bacterial mutation assay and the in vivo rat bone marrow micronucleus assay. Maribavir was positive in the absence of metabolic activation in the mouse lymphoma assay, and the results were equivocal in the presence of metabolic activation.

Impairment of Fertility Although decreased sperm straight line velocity was observed in males (at maribavir exposures less than those observed in humans at the RHD), there were no effects on fertility in males or females in a combined oral fertility and embryo-fetal study in rats administered maribavir at up to 400 mg/kg/day [see Use in Specific Populations (8.1) ] .

📄 Patient Package Insert ~3 min read ▾

Patient Information LIVTENCITY (liv-TEN-city) (maribavir) tablets This Patient Information has been approved by the U.S. Food and Drug Administration. MAR358 R4 Revised: March 2024 What is LIVTENCITY?

LIVTENCITY is a prescription medicine used to treat cytomegalovirus (CMV) infection and disease in adults and children 12 years of age and older weighing at least 77 pounds (35 kg) who have received a transplant, when their infection or disease does not respond to treatment with the medicines ganciclovir, valganciclovir, cidofovir or foscarnet. It is not known if LIVTENCITY is safe and effective in children under 12 years of age. Before taking LIVTENCITY, tell your healthcare provider about all your medical conditions, including if you: are pregnant or plan to become pregnant.

It is not known if LIVTENCITY will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if LIVTENCITY passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with LIVTENCITY.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. LIVTENCITY may affect the way other medicines work, and other medicines may affect how LIVTENCITY works and cause serious side effects. Especially tell your healthcare provider if you take a seizure (anticonvulsant) medicine.

You can ask your healthcare provider or pharmacist for a list of medicines that interact with LIVTENCITY. Do not start a new medicine without telling your healthcare provider . Your healthcare provider will tell you if it is safe to take LIVTENCITY with other medicines.

Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine. How should I take LIVTENCITY?

Take LIVTENCITY exactly as your healthcare provider tells you to take it. Take LIVTENCITY 2 times a day. Take LIVTENCITY with or without food.

Swallow LIVTENCITY tablets whole. If you are not able to swallow tablets whole, you can break apart (disperse) the tablets in drinking water or crush the tablets and mix with drinking water and take by mouth. See the " Instructions for Use " for detailed instructions on how to prepare and give a dose of LIVTENCITY tablets by dispersing or crushing tablets and taking by mouth.

If you have a Nasogastric (NG) or Orogastric (OG) Tube (French size 10 or larger), you can disperse the tablets and take through a NG or OG tube. See the " Instructions for Use " for detailed instructions on how to prepare and give a dose of LIVTENCITY tablets through a NG or OG Tube. If you take too much LIVTENCITY, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of LIVTENCITY? The most common side effects of LIVTENCITY include: changes in taste nausea diarrhea vomiting tiredness These are not all the possible side effects of LIVTENCITY. Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088. How should I store LIVTENCITY? Store LIVTENCITY at room temperature between 68°F to 77°F (20°C to 25°C).

Keep LIVTENCITY and all medicines out of the reach of children. General information about the safe and effective use of LIVTENCITY. Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet.

Do not use LIVTENCITY for a condition for which it was not prescribed. Do not give LIVTENCITY to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about LIVTENCITY that is written for health professionals. What are the ingredients in LIVTENCITY? Active ingredient: maribavir Inactive ingredients: FD&C Blue #1, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, titaniu… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

Instructions for Use LIVTENCITY (liv-TEN-city) (maribavir) tablets, for oral use This Instructions for Use contains information on how to prepare and give a dose of LIVTENCITY tablets by breaking apart (dispersing) or crushing in drinking water and taking by mouth; or dispersing and giving through a Nasogastric (NG) or Orogastric (OG) Tube. Read this Instructions for Use before you prepare or give the first dose of LIVTENCITY, and each time you get a refill. Ask your healthcare provider or pharmacist if you have any questions.

Important information you need to know before preparing a dose of LIVTENCITY: You can break apart (disperse) the tablets in drinking water or crush the tablets and mix with drinking water. The tablet will not be completely dispersed in the mixture. Do not mix LIVTENCITY with any liquid other than drinking water.

LIVTENCITY tablets that have been dispersed in drinking water can be given through a Nasogastric (NG) or Orogastric (OG) tube (French size 10 or larger). You can prepare the mixture ahead of time and store at room temperature 68°F to 77°F (20°C to 25°C) for up to 8 hours. Preparing a dose of LIVTENCITY by dispersing or crushing tablets and taking by mouth: Gather the following supplies: small, clean container to place tablets and water in drinking water Step 1: Choose a clean, flat work surface.

Place all supplies on the work surface. Step 2: Wash and dry your hands well. Step 3: Get the prescribed number of LIVTENCITY tablets needed to prepare the dose.

Step 4: Place the LIVTENCITY tablets into the container. Note: If you prefer, you can crush the tablets with a spoon before adding water. Step 5: Add the amount of drinking water needed for your prescribed dose.

Number of Tablets Amount of Drinking Water 2 30 mL 4 60 mL 6 90 mL Step 6: Swirl the container gently to disperse the tablets in the water and swallow the mixture right away. The mixture will have a bitter taste. Step 7: Rinse the container with 15 mL of drinking water and swallow the mixture.

Repeat Step 7. Check that no pieces of tablet are left in the container. Repeat Step 7 until no pieces remain.

Preparing and giving a dose of LIVTENCITY through a Nasogastric (NG) or Orogastric (OG) Tube: Gather the following supplies: 50 mL or 60 mL syringe drinking water Step 1: Remove the cap (if capped) and plunger out of a 50 mL or 60 mL syringe. Add 2 tablets into the syringe body and place the plunger back in the syringe. Note: Only 2 tablets can be given through the NG or OG tube at a time.

Step 2: Withdraw 30 mL of drinking water into the syringe. Step 3: Hold the syringe with the tip pointing upward. Pull the plunger back so there is some air space in the syringe.

If there is a cap, place the cap back on the syringe. Shake the syringe well for about 30 to 45 seconds or until the tablets are completely dispersed. Be careful not to spill the contents of the syringe.

Step 4: Remove the cap (if capped) from the syringe again and attach the syringe to the NG or OG tube and give the mixture right away. Step 5: Withdraw 15 mL of drinking water into the same syringe and flush through the NG or OG tube. Repeat Step 5.

Check that no pieces of tablet are left in the syringe. Repeat Step 5 until no pieces remain. Note: If your prescribed dose is more than 2 tablets, Repeat Steps 1 through 5 until you give the full prescribed dose.

Storing LIVTENCITY: Store LIVTENCITY at room temperature 68°F to 77°F (20°C to 25°C). Keep LIVTENCITY and all medicines out of the reach of children. For more information, go to www.explorelivtencity.com or call 1-877-TAKEDA-7 (1-877-825-3327).

Distributed by: Takeda Pharmaceuticals America, Inc., Cambridge, MA 02142 LIVTENCITY and are registered trademarks of Takeda Pharmaceuticals International AG. TAKEDA and are registered trademarks of Takeda Pharmaceutical Company Limited. ©2024 Takeda Pharmaceuticals U.S.A., Inc. All rights reserved.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 31 words ▾

Dosage and Administration, ( 2.2 , 2.3 , 2.4 ) 11/2025 Warnings and Precautions, Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions ( 5.3 ) 11/2025

📄 Package Label / Principal Display Panel 66 words ▾

PRINCIPAL DISPLAY PANEL - 200 mg Bottle Carton NDC 64764-800-28 LIVTENCITY ® (maribavir) tablets 200 mg Rx Only 28 Tablets For Oral Use Takeda PRINCIPAL DISPLAY PANEL - 200 mg Bottle Carton

PRINCIPAL DISPLAY PANEL - 200 mg Bottle Carton NDC 64764-800-56 LIVTENCITY ® (maribavir) tablets 200 mg Rx Only 56 Tablets For Oral Use Takeda PRINCIPAL DISPLAY PANEL - 200 mg Bottle Carton 56 Tablets

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 – Q4 2025 · 4 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
70
Units reimbursed last 4 qtrs
6.8K
Gross reimbursed last 4 qtrs
$1.56M
Avg / prescription
$22,274.79
Avg / unit
$228.13
Latest quarter Q4 2025
15Rx
Fee-for-service vs managed care ⓘ
100% FFS
Fee-for-service · 70 Rx Managed care · 0 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: 6,835 units · 34.9 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: no data reported 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: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
34.934.9
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 New York 34.9 /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.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
56 tablets this page64764-0800-56 70 Rx · $1,559,236
28 tablets64764-0800-28 66 Rx · $1,670,589
Drug total (last 4 qtrs): 136 Rx · 14,143 units · $3,229,825 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Livtencity — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Livtencity. 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
$23.45M
Claims incl. refills
934
Beneficiaries
474
Spend / beneficiary
$49,466.40
Spend / claim
$25,103.93
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Livtencity (this brand).

Top reported reactions

Death318
Dysgeusia265
Taste Disorder229
Hospitalisation223
Cytomegalovirus Infection186
Drug Resistance177
Fatigue176

Reporter sex

2,410 reports
Male · 57%
Female · 43%

Serious outcomes

Death526
Disabling4
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 562 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

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

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Takeda Pharmaceuticals America, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 28 tablets (64764-0800-28). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Takeda Pharmaceuticals America, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 64764-0750-07 · Takeda 64764-0805-10 · Takeda →
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.