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Xenleta lefamulin acetate 600 mg Tablet, Coated, 10-count — NDC 71288-0037-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Xenleta lefamulin acetate 600 mg Tablet, Coated, 10-count — NDC 71288-037-10 (Billing 71288-0037-10)

by Meitheal Pharmaceuticals Inc. · 10 TABLET, COATED in 1 BLISTER PACK

This is a package of 10 tablets of Xenleta lefamulin acetate 600 mg Tablet, Coated from Meitheal Pharmaceuticals Inc., marketed since Sep 2019 and currently FDA-listed. It is this product's only package size.

NDC 71288-0037-10
🏷️ FDA NDC (as labeled) 71288-037-10 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71288-037-10
Product NDC 71288-037
11-digit billing NDC 71288003710
RxCUI 2198948, 2198953, 2198961, 2198966, 2747671, 2747672
UNII HDN0B924X4, XF417D3PSL
Application # NDA211672
SPL Set ID eb972ea8-7502-422e-84bb-66cb8e93ca06
Established class (EPC) Calculi Dissolution Agent; Anti-coagulant
Mechanism of action Acidifying Activity; Calcium Chelating Activity
Physiologic effect Decreased Coagulation Factor Activity
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-09-09
Route ORAL
Dosage form TABLET, COATED
Substance LEFAMULIN ACETATE
Quick answers
  • RxCUI (RxNorm): 2198948
Why two NDCs? The FDA registers this code as 71288-037-10 — 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 → 71288-0037-10. 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 Pleuromutilin Antibacterial class.

Pharmacologic class Pleuromutilin Antibacterial
Drug family (ATC) Other antibacterials
How it works Cytochrome P450 3A4 Inhibitors, Cytochrome P450 3A 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

📖 What it is MedlinePlus · NLM

Lefamulin is used to treat community acquired pneumonia (a lung infection that developed in a person who was not in the hospital) caused by certain types of bacteria. Lefamulin is in a class of medications called pleuromutilin antibiotics. It works by slowing the growth or killing bacteria that cause infections. Antibiotics such as lefamulin will not work for colds, flu, or other viral infections. Taking antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Xenleta is an antibiotic specifically approved to treat community-acquired bacterial pneumonia — that's pneumonia you pick up in the community, not in a hospital. It works against...
  • Yes — this one is important. You should take Xenleta tablets at least 1 hour before eating or 2 hours after a meal. Eating a fatty meal before the tablet reduces how much medicine...
  • Do I need to take the tablet on an empty stomach?
  • The most common side effects with the tablet form are diarrhea, nausea, and vomiting — those are bothersome but usually manageable. You should call your doctor right away if you de...
📖 Read our full Lefamulin guide →
7
Nutrient depletion considerations

Lefamulin Acetate may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Lefamulin Acetate nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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
71288-0037-10 You're viewing this Main listing 10 TABLET, COATED in 1 BLISTER PACK 2019-09-09 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Xenleta 600 mgthis 71288-0037-10 Meitheal 10 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

🏛️
2019
First FDA approval
Aug 2019
📍
2026
Currently FDA-listed
7 years listed
🛡️
2033
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 Mar 2033. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Aug 19, 2019 RLD RS ⏳ ~6.5 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 8071643 — drug substance
US 8153689 — drug substance
US 9120727 — drug substance
Exclusivity NCE
Exclusivity GAIN
2019 2021 2023 2025 2027 2029 2031 2033
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 (3)
PatentTypeUse codeExpires
US 8071643 ↗ Drug substance — Mar 25, 2033
US 8153689 ↗ Drug substance — Mar 19, 2028
US 9120727 ↗ Drug substance — May 23, 2031
FDA exclusivity
CodeWhat it grantsExpires
NCENew Chemical Entity (5-year)Aug 19, 2024
GAINQualified Infectious Disease Product (+5-year)Aug 19, 2029
Common questions
Is there a generic version of this drug?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for this drug. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Mar 2033 — 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
ImprintLEF;600
Size2 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 029TFK992N
    Croscarmellose is a modified cellulose powder that helps tablets and capsules break apart quickly when swallowed. It works as a disintegrant, allowing the medicine to dissolve and be absorbed properly in your body.
  • 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 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • 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 U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • 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 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

LabelerMeitheal Pharmaceuticals Inc.
Application holderHONG KONG KING FRIEND INDUSTRIAL CO LTD
FDA applicationNDA211672 (NDA)
Labeler code71288
First marketedSep 2019
Product typeHuman Prescription Drug
Portfolio158 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 190 words ▾

1 INDICATIONS AND USAGE XENLETA is a pleuromutilin antibacterial indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by susceptible microorganisms. ( 1.1 ) To reduce the development of drug resistant bacteria and maintain the effectiveness of XENLETA and other antibacterial drugs, XENLETA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.2 )

1.1Community-Acquired Bacterial Pneumonia (CABP) XENLETA is indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae , Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae , Legionella pneumophila , Mycoplasma pneumoniae , and Chlamydophila pneumoniae .

1.2Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of XENLETA and other antibacterial drugs, XENLETA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION For treatment of adults with CABP, the recommended dosage of XENLETA is as follows: *With the option to switch to XENLETA Tablets 600 mg every 12 hours to complete the treatment course. Dosage Treatment Duration 150 mg every 12 hours by intravenous infusion over 60 minutes* ( 2.1 ) 5 to 7 days 600 mg orally every 12 hours. ( 2.1 ) 5 days Patients with Hepatic Impairment : Reduce the dosage of XENLETA Injection to 150 mg infused over 60 minutes every 24 hours in patients with severe hepatic impairment (Child-Pugh Class C).

XENLETA Tablets have not been studied in and are not recommended for patients with moderate (Child-Pugh Class B) or severe hepatic impairment ( 2.2 ). Administration Instruction for XENLETA Tablets : Take at least 1 hour before a meal or 2 hours after a meal. Swallow XENLETA Tablets whole with water (6 to 8 ounces).

( 2.3 ) Administration Instruction for XENLETA Injection : Infuse over 60 minutes. ( 2.3 ) See Full Prescribing Information for additional information on the administration and preparation of XENLETA Tablets and Injection. ( 2.4 )

2.1Recommended Dosage For treatment of adults with CABP, the recommended dosage of XENLETA is described in Table 1 below. For patients with severe hepatic impairment, dosage adjustment is required [see Dosage and Administration ( 2.2 )] . Table 1: Dosage of XENLETA in Adult CABP Patients *With the option to switch to XENLETA Tablets 600 mg every 12 hours to complete the treatment course.

Dosage Treatment Duration 150 mg every 12 hours by intravenous infusion over 60 minutes* 5 to 7 days 600 mg orally every 12 hours 5 days

2.2Dosage Adjustment for Patients with Hepatic Impairment Monitor patients with hepatic impairment for adverse reactions associated with XENLETA Injection and Tablets throughout the treatment period [see Use in Specific Populations ( 8.6 ) and Clinical Pharmacology ( 12.3 )]. XENLETA Injection Reduce the dosage of XENLETA Injection to 150 mg infused intravenously over 60 minutes every 24 hours for patients with severe hepatic impairment (Child-Pugh Class C). No dosage adjustment of XENLETA Injection is needed for patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment.

XENLETA Tablets XENLETA Tablets have not been studied in and are not recommended for patients with moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment. No dosage adjustment of XENLETA Tablets is needed for patients with mild hepatic impairment (Child-Pugh Class A).

2.3Important Administration Instructions XENLETA Injection Administer XENLETA Injection by intravenous infusion over 60 minutes. Must dilute in a 250 mL solution of 10 mM citrate buffered 0.9% sodium chloride for injection supplied with XENLETA Injection before use [see Dosage and Administration ( 2.4 )] . XENLETA Tablets Take XENLETA Tablets at least 1 hour before a meal or 2 hours after a meal.

Swallow XENLETA Tablets whole with water (6 to 8 ounces). Do not crush or divide XENLETA Tablets [see Clinical Pharmacology ( 12.3 )]. Missed Dose If a dose is missed, the patient should take the dose as soon as possible and anytime up to 8 hours prior to the next scheduled dose.

If less than 8 hours remain before the next scheduled dose, do not take the missed dose, and resume dosing at the next scheduled dose.

2.4Preparation of XENLETA Injection for Intravenous Infusion Dilute the entire 15 mL vial of XENLETA Injection into the diluent bag supplied with XENLETA injection that contains 250 mL of 10 mM citrate buffered 0.9% sodium chloride. Use aseptic technique when adding XENLETA Injection into the diluent bag. Mix thoroughly.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Use the diluent bag only if the solution is clear and the container is undamaged. Do not use the diluent bag in series connections.

Do not add other additives… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 99 words ▾

3 DOSAGE FORMS AND STRENGTHS XENLETA Injection Clear, colorless solution in a single-dose clear glass vial. Each vial contains 150 mg of lefamulin in 15 mL of 0.9% sodium chloride for further dilution [see Dosage and Administration ( 2.4 )] . XENLETA Tablets Blue, oval, film-coated tablet with ‘LEF 600’ printed in black on one side.

Each tablet contains 600 mg of lefamulin. Injection A single-dose clear glass vial containing 150 mg of lefamulin in 15 mL of 0.9% sodium chloride for further dilution prior to intravenous infusion. ( 3 ) Tablets 600 mg of lefamulin.

( 3 )

⛔ Contraindications 136 words ▾

4 CONTRAINDICATIONS XENLETA is contraindicated in patients with known hypersensitivity to lefamulin, pleuromutilin class drugs, or any of the components of XENLETA. ( 4.1 ) Concomitant use of XENLETA tablets with CYP3A substrates that prolong the QT interval is contraindicated. ( 4.2 )

4.1Hypersensitivity XENLETA is contraindicated in patients with known hypersensitivity to lefamulin, pleuromutilin class drugs, or any of the components of XENLETA.

4.2CYP3A4 Substrates That Prolong the QT Interval XENLETA Tablets are contraindicated with sensitive CYP3A4 substrates that prolong the QT interval (for example, pimozide). Concomitant administration of oral XENLETA with sensitive CYP3A4 substrates may result in increased plasma concentrations of these drugs, leading to QT prolongation and cases of torsades de pointes [see Warnings and Precautions ( 5.1 ), Drug Interactions ( 7.2 ), and Clinical Pharmacology ( 12.3 )] .

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS QT Prolongation : Avoid use in patients with known QT prolongation, ventricular arrhythmias including torsades de pointes, and patients receiving drugs that prolong the QT interval such as antiarrhythmic agents. ( 5.1 ) Embryo-Fetal Toxicity : May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception.

( 5.2 , 8.1 , 8.3 ) Clostridioides difficile -associated Diarrhea (CDAD) : Evaluate patients who develop diarrhea. ( 5.3 )

5.1QT Prolongation XENLETA has the potential to prolong the QT interval of the electrocardiogram (ECG) in some patients. Avoid XENLETA use in the following patients: Patients with known prolongation of the QT interval Patients with ventricular arrhythmias including torsades de pointes Patients receiving Class IA (for example, quinidine, procainamide) or Class III (for example, amiodarone, sotalol) antiarrhythmic agents Patients receiving other drugs that prolong the QT interval, such as antipsychotics, erythromycin, pimozide, moxifloxacin, and tricyclic antidepressants In patients with renal failure who require dialysis, metabolic disturbances associated with renal failure may lead to QT prolongation.

In patients with mild, moderate, or severe hepatic impairment, metabolic disturbances associated with hepatic impairment may lead to QT prolongation. If use with XENLETA cannot be avoided in specific populations predisposed to QT prolongation or those receiving another drug that prolongs the QT interval, ECG monitoring is recommended during treatment. The magnitude of QT prolongation may increase with increasing concentrations of XENLETA or increasing the rate of infusion of the intravenous formulation.

Therefore, the recommended dose and infusion rate should not be exceeded.

5.2Embryo-Fetal Toxicity Based on findings from animal studies, lefamulin may cause fetal harm when administered to pregnant women. Animal studies indicate that administration of lefamulin resulted in an increased incidence of post-implantation fetal loss and stillbirths in rats and rabbits treated during the period of organogenesis or in rats treated from the beginning of organogenesis through the time of weaning. Additional rat pup deaths were observed during early lactation that were likely related to maternal treatment with lefamulin.

Decreased fetal body weights and ossification in rats and rabbits, and apparent delay in sexual maturation in rats may indicate treatment-related developmental delay, while other findings such as malformations in rats at systemic exposures lower than the systemic exposure in CABP patients may indicate a risk for embryo-fetal toxicity. Verify pregnancy status in females of reproductive potential prior to initiating XENLETA. Advise females of reproductive potential to use effective contraception during treatment with XENLETA and for 2 days after the final dose.

Advise pregnant women and females of reproductive potential of the potential risk to a fetus [see Use in Specific Populations ( 8.1 , 8.3 )] .

5.3Clostridioides difficile -associated Diarrhea Clostridioides difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XENLETA, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD.

Hypertoxin-producing isolates of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibacterial drug… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: QT Prolongation [see Warnings and Precautions ( 5.1 )] . Clostridioides difficile -associated Diarrhea [see Warnings and Precautions ( 5.3 )] . Most common adverse reactions (incidence ≥2%) are: XENLETA Injection : administration site reactions, hepatic enzyme elevation, nausea, hypokalemia, insomnia, headache.

( 6.1 ) XENLETA Tablets : diarrhea, nausea, vomiting, hepatic enzyme elevation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Meitheal Pharmaceuticals Inc. at 1-888-808-5529 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. XENLETA was evaluated in two clinical trials in CABP patients (Trial 1 and Trial 2). Across the two trials, a total of 641 patients were treated with XENLETA.

Trial 1 (intravenous [IV] to oral dosing switch trial) enrolled 551 adult patients, 276 randomized to XENLETA (273 received at least one dose of XENLETA) and 275 randomized to moxifloxacin (273 received at least one dose of moxifloxacin). Trial 2 (oral dosing only trial) enrolled 738 adult patients, 370 randomized to XENLETA (368 received at least one dose of XENLETA) and 368 randomized to moxifloxacin (all 368 received at least one dose of moxifloxacin). Trial 1 enrolled patients with Pneumonia Outcomes Research Team (PORT) Risk Class III-V.

The mean duration of intravenous treatment was 6 days; the mean total duration of treatment was 7 days. Trial 2 enrolled patients with PORT Risk Class II-IV. The mean duration of treatment was 5 days for XENLETA and 7 days for moxifloxacin.

In Trial 1 and Trial 2 (pooled), the median age of patients treated with XENLETA was 61 (range 19-97) years; 42% of patients were 65 years or older and 18% were 75 years or older. Patients were predominantly male (58%) and white (79%) and had a median body mass index (BMI) of 26.0 (range 13.0-56.8) kg/m 2 . Approximately 52% of XENLETA-treated patients had creatinine clearance (CrCl) <90 mL/min.

Serious Adverse Reactions and Adverse Reactions Leading to Discontinuation In Trial 1 and Trial 2 (pooled), serious adverse reactions occurred in 36/641 (5.6%) patients treated with XENLETA and 31/641 (4.8%) patients treated with moxifloxacin. Treatment was discontinued due to an adverse reaction in 21/641 (3.3%) patients treated with XENLETA and 21/641 (3.3%) patients treated with moxifloxacin. Death within 28 days occurred in 8/641 (1.2%) patients treated with XENLETA and 7/641 (1.1%) patients treated with moxifloxacin.

Most Common Adverse Reactions Table 2 and Table 3 include adverse reactions occurring in ≥2% of patients receiving XENLETA in Trials 1 and 2. Table 2: Adverse Reactions Occurring in ≥2% of Patients Receiving XENLETA in Trial 1 *Administration site reactions include infusion site pain, infusion site phlebitis, and injection site reaction. **Hepatic enzyme elevation includes alanine aminotransferase increased, aspartate aminotransferase increased, and liver function test increased. Adverse Reaction Trial 1 IV ± Oral Dosing XENLETA N=273 Moxifloxacin N=273 Administration site reactions* 7% 3% Hepatic enzyme elevation** 3% 3% Nausea 3% 2% Hypokalemia 3% 2% Insomnia 3% 2% Headache 2% 2% Table 3: Adverse Reactions Occurring in ≥2% of Patients Receiving XENLETA in Trial 2 **Hepatic enzyme elevation includes alanine aminotransferase increased, aspartate aminotransferase increased, and liver function test increased.

Adverse Reaction Trial 2 Oral Dosing XENLETA N=368 Moxifloxacin N=368 Diarrhea 12% 1% Nausea 5% 2% Vomiting 3% 1% Hepatic enzyme elevation** 2% 2% Selected Adverse Reactions Occurring in Less Than 2% of Patients Receiving XENLETA in Trials 1 and… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS XENLETA Injection Strong or moderate CYP3A inducers or P-gp inducers Avoid XENLETA unless the benefit outweighs the risk. Monitor for reduced efficacy. ( 7.1 ) XENLETA Tablets Strong or moderate CYP3A inducers or P-gp inducers Avoid XENLETA unless the benefit outweighs the risk.

Monitor for reduced efficacy. ( 7.1 ) Strong CYP3A inhibitors or P-gp inhibitors Avoid XENLETA. ( 7.1 ) Moderate CYP3A inhibitors or P-gp inhibitors Monitor for adverse reactions.

( 7.1 ) CYP3A substrates that prolong the QT interval Concomitant use is contraindicated. ( 4.2 , 7.2 ) Midazolam and other sensitive CYP3A substrates Monitor for adverse reactions. ( 7.2 )

7.1Effect of Other Drugs on XENLETA Strong and Moderate CYP3A Inducers or P-gp Inducers Concomitant use of oral or intravenous XENLETA with strong CYP3A4 inducers or P-gp inducers decreases lefamulin AUC and C max [see Clinical Pharmacology ( 12.3 )] , which may reduce the efficacy of XENLETA. Avoid concomitant use of XENLETA Injection and XENLETA Tablets with strong and moderate CYP3A4 inducers or P-gp inducers unless the benefit outweighs the risks. Strong and Moderate CYP3A Inhibitors or P-gp Inhibitors Concomitant use of XENLETA Tablets with strong CYP3A inhibitors or P-gp inhibitors increases lefamulin AUC [see Clinical Pharmacology ( 12.3 )] , which may increase the risk of adverse reactions with XENLETA Tablets.

Avoid concomitant use of XENLETA Tablets with strong CYP3A inhibitors or P-gp inhibitors. Monitor for adverse effects of XENLETA Tablets when administered concomitantly with moderate CYP3A inhibitors or P-gp inhibitors.

7.2Effect of XENLETA on Other Drugs CYP3A4 Substrates Concomitant use of XENLETA Tablets with sensitive CYP3A4 substrates increases the AUC and C max of CYP3A4 substrates [see Clinical Pharmacology ( 12.3 )] , which may increase the risk of toxicities associated with cardiac conduction. Concomitant use with CYP3A substrates known to prolong the QT interval is contraindicated [see Contraindications ( 4.2 )] . Concomitant use of sensitive CYP3A substrates with XENLETA Tablets requires close monitoring for adverse effects of these drugs (for example, alprazolam, diltiazem, verapamil, simvastatin, vardenafil).

Concomitant use of XENLETA Injection with CYP3A4 substrates does not affect the exposure of CYP3A4 substrates.

7.3Drugs that Prolong QT The pharmacodynamic interaction potential to prolong the QT interval of the electrocardiogram between XENLETA and other drugs that effect cardiac conduction is unknown. Therefore, avoid concomitant use of XENLETA Injection and XENLETA Tablets with such drugs (for example, Class IA and III antiarrhythmics, antipsychotics, erythromycin, moxifloxacin, tricyclic antidepressants).

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation : A lactating woman should pump and discard human milk for the duration of treatment with XENLETA and for 2 days after the final dose. ( 8.2 )

8.1Pregnancy Risk Summary Based on findings from animal studies, lefamulin may cause fetal harm when administered to pregnant women. There are no available data on the use of XENLETA in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal studies indicate that intravenous administration of lefamulin during organogenesis resulted in an increased incidence of prenatal mortality at mean maternal exposures 0.9 times the mean exposure in clinical patients (based on AUC 0-24h ), decreased fetal body weights, apparent delay in sexual maturation that suggest treatment-related developmental delay, and malformations in rats at maternal exposures greater than 0.4 times the mean exposure in CABP patients for which the litter incidence was nonexistent in concurrent controls and rare (0 to approximately 0.3%) in historical controls.

Decreased ossification was seen in fetuses at all doses in a dose-related manner, suggestive of developmental delay (see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. There is a pregnancy pharmacovigilance program for XENLETA. If XENLETA is inadvertently administered during pregnancy or if a patient becomes pregnant while receiving XENLETA, healthcare providers should report XENLETA exposure by calling 1-888-808-5529 to enroll.

Data Animal Data In a prenatal and postnatal development study in rats treated from the beginning of organogenesis through lactation (Gestation Day [GD] 6 through lactation day 21), the percent of live births was reduced (87.4% compared with the concurrent control of 98.7%) in the high dose group of 100 mg/kg/day (0.9 times the mean exposure in CABP patients treated IV). Equivocal findings in that study were indicative of early post-natal mortality and apparent developmental delay that may be related to pre-natal effects.

In the rat embryo-fetal development study of IV lefamulin during organogenesis (GD 6-17), findings included late resorptions in the high-dose group and malformations (cleft palate/jaw/vertebral malformations at the mid and high doses and enlarged ventricular heart chamber with a thin ventricular wall at the high dose) for which the litter incidence was nonexistent in concurrent controls and rare in historical controls (0 to approximately 0.3%). Decreased or no ossification in a number of skeletal elements in all treated groups may indicate treatment-related developmental delay at all doses.

The mean exposure at the lowest dose was approximately 0.4 times the mean exposure in CABP patients treated IV. The main human metabolite, 2 R -hydroxy lefamulin, was evaluated in an embryo-fetal development study in rats after IV administration and was also associated with the same cardiac malformation seen in the above study, enlarged ventricular heart chamber with or without a thin ventricular wall (which could be associated with undetected valve or great vessel anomalies). In the rabbit embryo-fetal development study of IV lefamulin during organogenesis (GD 6-18), low numbers of live fetuses in utero in treated groups limited evaluation of the study.

Additional findings at the high dose included decreased fetal weight and decreased or no ossification of skeletal elements, which may be indicative of developmental delay. A NOAEL was not determined. The lowest dose (not fully evaluated due to fetal mortality) would correspond to a mean exposure approximately 0.1 times the mean exposure in… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Based on findings from animal studies, lefamulin may cause fetal harm when administered to pregnant women. There are no available data on the use of XENLETA in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal studies indicate that intravenous administration of lefamulin during organogenesis resulted in an increased incidence of prenatal mortality at mean maternal exposures 0.9 times the mean exposure in clinical patients (based on AUC 0-24h ), decreased fetal body weights, apparent delay in sexual maturation that suggest treatment-related developmental delay, and malformations in rats at maternal exposures greater than 0.4 times the mean exposure in CABP patients for which the litter incidence was nonexistent in concurrent controls and rare (0 to approximately 0.3%) in historical controls.

Decreased ossification was seen in fetuses at all doses in a dose-related manner, suggestive of developmental delay (see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. There is a pregnancy pharmacovigilance program for XENLETA. If XENLETA is inadvertently administered during pregnancy or if a patient becomes pregnant while receiving XENLETA, healthcare providers should report XENLETA exposure by calling 1-888-808-5529 to enroll.

Data Animal Data In a prenatal and postnatal development study in rats treated from the beginning of organogenesis through lactation (Gestation Day [GD] 6 through lactation day 21), the percent of live births was reduced (87.4% compared with the concurrent control of 98.7%) in the high dose group of 100 mg/kg/day (0.9 times the mean exposure in CABP patients treated IV). Equivocal findings in that study were indicative of early post-natal mortality and apparent developmental delay that may be related to pre-natal effects.

In the rat embryo-fetal development study of IV lefamulin during organogenesis (GD 6-17), findings included late resorptions in the high-dose group and malformations (cleft palate/jaw/vertebral malformations at the mid and high doses and enlarged ventricular heart chamber with a thin ventricular wall at the high dose) for which the litter incidence was nonexistent in concurrent controls and rare in historical controls (0 to approximately 0.3%). Decreased or no ossification in a number of skeletal elements in all treated groups may indicate treatment-related developmental delay at all doses.

The mean exposure at the lowest dose was approximately 0.4 times the mean exposure in CABP patients treated IV. The main human metabolite, 2 R -hydroxy lefamulin, was evaluated in an embryo-fetal development study in rats after IV administration and was also associated with the same cardiac malformation seen in the above study, enlarged ventricular heart chamber with or without a thin ventricular wall (which could be associated with undetected valve or great vessel anomalies). In the rabbit embryo-fetal development study of IV lefamulin during organogenesis (GD 6-18), low numbers of live fetuses in utero in treated groups limited evaluation of the study.

Additional findings at the high dose included decreased fetal weight and decreased or no ossification of skeletal elements, which may be indicative of developmental delay. A NOAEL was not determined. The lowest dose (not fully evaluated due to fetal mortality) would correspond to a mean exposure approximately 0.1 times the mean exposure in CABP patients.

Results of animal studies indicate that lefamulin crosses the placenta and is found in fetal tissues. Following a single intravenous administration of 30 mg/kg radio-la… [Excerpted — this section continues on DailyMed.]

🧒 Pediatric Use 22 words ▾

8.4Pediatric Use The safety and effectiveness of XENLETA in patients less than 18 years of age has not yet been established.

🧓 Geriatric Use 96 words ▾

8.5Geriatric Use Of the 646 patients randomized to XENLETA in Trials 1 and 2, 268 (41.5%) were ≥65 years of age. Early clinical response (ECR) rates in the subgroup of patients ≥65 were similar to ECR rates in subjects <65 years of age and comparable across treatment groups (XENLETA versus moxifloxacin). The adverse reaction profiles in patients ≥65 years and in patients <65 years of age were similar.

The percentage of patients in the XENLETA group who had at least one adverse reaction was 30% in patients ≥65 years and 38% in patients <65 years.

🆘 Overdosage 23 words ▾

10 OVERDOSAGE Treatment of overdose with XENLETA should consist of observation and general support measures. Lefamulin and its primary metabolite are not dialyzable.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action XENLETA is an antibacterial drug [see Microbiology ( 12.4 )] .

12.2Pharmacodynamics The 24 h free-drug AUC to minimal inhibitory concentration (MIC) ratio has been shown to be the best Pharmacokinetic-Pharmacodynamic (PK-PD) index for the antibacterial activity of lefamulin in animal infection models of Streptococcus pneumoniae and Staphylococcus aureus pneumonia. Cardiac Electrophysiology The QTcF interval prolongation risk of XENLETA was evaluated using 2 randomized, double-blind, double-dummy, active controlled (moxifloxacin 400 mg once daily), parallel group, trials (Trials 1 and 2) in adult patients with CABP.

A concentration dependent QTc prolongation effect of XENLETA was observed. The mean change from baseline QTcF (90% two-sided upper confidence interval) values around T max on day 3 or 4 were 13.6 ms (15.5 ms) for 150 mg injection administered twice daily as infusion and 9.3 ms (10.9 ms) for 600 mg tablet administered twice daily. The mean change from baseline QTcF (90% two-sided upper confidence interval) values around T max for the moxifloxacin randomized comparison arm on day 3 or 4 were 16.4 ms (18.3 ms) for 400 mg injection administered once daily as infusion and 11.6 ms (13.2 ms) for 400 mg tablet administered once daily.

12.3Pharmacokinetics Following single-dose intravenous administration, the AUC of lefamulin increased approximately dose-proportionally while the C max of lefamulin increased less than dose-proportionally over a dose range of 25 mg (0.17 times the approved dose) to 400 mg (2.67 times the approved dose). Following single-dose oral administration, the AUC of lefamulin increased more than dose proportionally over a dose range of 500 mg (0.8 times the approved dose) to 750 mg (1.25 times the approved dose). Pharmacokinetic (PK) parameters of lefamulin following administration of XENLETA Injection or Tablets to patients with CABP are listed in Table 4 .

The mean lefamulin AUC 0-24h and C max in patients with CABP were 73% and 30% higher, respectively, compared with healthy subjects. Table 4: Pharmacokinetic (PK) Parameters of Lefamulin Following Single or Multiple Dose (Every 12 Hours) XENLETA Administered as 150 mg (Infused Over 60 Minutes) Intravenously (IV) or 600 mg Orally in Patients with CABP a a Based on population PK modeling (Trial 1 for IV administration and Trial 2 for oral administration) b C max =maximum plasma concentration; C min =trough plasma concentration; AUC 0–24h =area under the plasma concentration-time curve from time zero to 24 hours c Dose administered under fasting conditions (1 hour before or 2 hours after a meal) PK Parameters b Administration Route Arithmetic Mean (% CV) Day 1 Steady State C max (mcg/mL) IV 3.50 (11.7) 3.60 (14.6) Oral c 2.24 (36.4) 2.24 (37.1) C min (mcg/mL) IV 0.398 (68.1) 0.573 (89.4) Oral c 0.593 (67.3) 0.765 (75.7) AUC 0-24h (mcg·h/mL) IV 27.0 (31.8) 28.6 (46.9) Oral c 30.7 (45.0) 32.7 (49.2) Absorption The mean oral bioavailability of XENLETA Tablets is approximately 25% and peak lefamulin plasma concentration occurred 0.88 to 2 hours after administration to healthy subjects.

Effect of Food The concomitant administration of a single oral dose of 600 mg XENLETA Tablets with a high fat (approximately 50% of total calories from fat), high calorie breakfast (approximately 800-1000 calories) slightly reduced bioavailability. The mean relative reduction for oral XENLETA (fasted vs. fed) was on average 22.9% [90% CI: 12.2; 32.3] for the C max and 18.43% [90% CI: 11.7; 24.7] for the AUC 0-inf . Distribution Mean plasma protein binding of lefamulin ranges from 94.8% at 2.35 mcg/mL to 97.1% at 0.25 mcg/mL in healthy adults.

The mean (min to max) steady state volume of distribution of lefamulin is

86.1L (34.2 to 153 L) in patients with CABP after administration of XENLETA Injection. Following a single IV administration of lefamulin 150 mg to healthy subjects, the highest lefamulin epithelial lining fluid (… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 15 words ▾

12.1Mechanism of Action XENLETA is an antibacterial drug [see Microbiology ( 12.4 )] .

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING XENLETA is supplied in the following strengths and package configurations: XENLETA Injection How Supplied XENLETA Injection is a clear, colorless, sterile, nonpyrogenic solution for intravenous administration containing 150 mg of lefamulin in 15 mL 0.9% sodium chloride in a single-dose vial intended for dilution in 250 mL of 10 mM citrate buffered (pH 5) 0.9% sodium chloride. The drug product is provided in a clear type I glass 15 mL vial with a gray rubber stopper, aluminum seal and flip off cap.

The diluent is provided in infusion bags containing 250 mL of sterile, nonpyrogenic 10 mM citrate buffered (pH 5) 0.9% sodium chloride solution. The vial stopper and infusion bag are not made with natural rubber latex. They are supplied as follows: NDC Xenleta (lefamulin) injection (10 mg per mL) Package Factor 71288- 039 -16 150 mg per 15 mL Single-Dose Vial 6 vials per carton NDC 0.9% sodium chloride solution Package Factor 71288- 040 -65 250 mL Bags 6 bags per carton Storage and Handling XENLETA Injection should be stored at 2°C to 8°C (36°F to 46°F).

Store in a refrigerator. Do not freeze. The diluent bags should be stored in barrier overwrap at 2°C to 25°C (36°F to 77°F) until ready to use. [see Dosage and Administration ( 2.5 )] .

XENLETA Tablets How Supplied XENLETA Tablets are available as blue, oval, film-coated tablets containing 600 mg lefamulin. The tablets are printed with 'LEF 600' in black on one side. They are supplied as follows: NDC Xenleta (lefamulin) tablets Package Factor 71288- 037 -10 600 mg tablets 10 tablets per blister card Storage and Handling XENLETA Tablets should be stored at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

📋 Description ~1 min read ▾

11 DESCRIPTION XENLETA is a semi-synthetic antibacterial agent for oral and intravenous administration. XENLETA, a pleuromutilin derivative, is available as 14- O -{[(1 R ,2 R ,4 R )-4-amino-2-hydroxy-cyclohexylsulfanyl]-acetyl}-mutilin in the form of an acetic acid salt (acetate). It is a chemical substance with a molecular weight of 567.79 grams per mole.

Its empirical formula is C 30 H 49 NO 7 S and its chemical structure is: XENLETA Tablets for oral administration are available as blue, oval, film-coated tablets containing 671 mg lefamulin acetate equivalent to 600 mg lefamulin. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, FD&C Blue No 2 aluminum lake, ferrosoferric oxide, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol (partially hydrolyzed), povidone K30, shellac glaze, talc, and titanium dioxide.

XENLETA Injection supplied as a sterile injection for intravenous use is available as a clear colorless solution in a glass vial containing 168 mg of lefamulin acetate equivalent to 150 mg of lefamulin in 15 mL of 0.9% sodium chloride. This is equivalent to 10 mg/mL lefamulin. The inactive ingredients are sodium chloride and water for injection.

XENLETA Injection must be diluted with the diluent supplied with XENLETA Injection, before administration by intravenous infusion. Each supplied diluent infusion bag contains 250 mL of 10 mM citrate buffered (pH 5) 0.9% sodium chloride. The diluent is a clear, colorless solution.

The inactive ingredients are citric acid anhydrous, sodium chloride, trisodium citrate dihydrate, and water for injection. Each 100 mL contains: sodium chloride 900 mg, trisodium citrate dihydrate 200 mg, and citric acid anhydrous 61.5 mg in water for injection. Electrolytes per 1000 mL: sodium 174 mEq; chloride 154 mEq.

The osmolality is 280-340 mOsm/kg and the pH is 4.5-5.5. Chemical Structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Diarrhea Advise patients that diarrhea is a common problem caused by antibacterial drugs, including XENLETA, which usually ends when the antibacterial drug is discontinued. Sometimes after starting treatment with an antibacterial drug, patients can develop watery stools (with or without stomach cramps and fever) which may be a sign of a more serious intestinal infection, even as late as 2 or more months after having taken the last dose of the antibacterial drug. If this occurs, instruct patients to contact their healthcare provider as soon as possible [see Warnings and Precautions ( 5.3 ), and Adverse Reactions ( 6.1 )] .

Nausea and Vomiting Advise patients that nausea and vomiting are common adverse reactions to XENLETA [see Adverse Reactions ( 6.1 )] . Drug Interactions Advise patients of the potential interaction other medications can have with XENLETA or the effect XENLETA may have on other medications, as these interactions may result in decreased effectiveness or increased toxicities of either XENLETA or the other medications. Patients should alert their physician if they are currently taking any medication(s) (including herbal or nutritional supplements) or are prescribed new medication(s) during treatment with XENLETA [see Drug Interactions ( 7 )] .

Allergic Reactions Advise patients that allergic reactions, including serious allergic reactions, could occur with XENLETA and that serious allergic reactions require immediate treatment. Ask the patient about any previous hypersensitivity reactions to XENLETA, or other pleuromutilin class antibacterial drugs [see Contraindications ( 4 )] . Administration with Food Advise patients that XENLETA should be taken at least 1 hour before a meal or 2 hours after a meal and should be swallowed whole with water (6 to 8 ounces).

XENLETA should not be crushed or divided [see Dosage and Administration ( 2.3 ) and Clinical Pharmacology ( 12.3 )] . Embryo-Fetal Toxicity Advise pregnant women and females of reproductive potential of the potential risk to a fetus, and to inform their healthcare provider of a known or suspected pregnancy. Advise patients to avoid becoming pregnant while receiving this drug [see Warnings and Precautions ( 5.2 ) and Use in Specific Populations ( 8.1 )] .

Advise females of reproductive potential to use effective contraception during treatment with XENLETA and for 2 days after the final dose [see Warnings and Precautions ( 5.2 ) and Use in Specific Populations ( 8.3 )] . Inform patients that Meitheal Pharmaceuticals has a surveillance program for pregnant women who have inadvertently taken XENLETA during pregnancy. Advise patients to call 1-888-808-5529 to enroll [see Use in Specific Populations ( 8.1 )] .

Lactation Advise lactating women to pump and discard human milk for the duration of treatment with XENLETA and for 2 days after the final dose [see Use in Specific Populations ( 8.2 )] . Antibacterial Resistance Patients should be counseled that antibacterial drugs including XENLETA should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold).

When XENLETA is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of treatment, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by XENLETA or other antibacterial drugs in the future [see Warnings and Precautions ( 5.4 )] . meitheal ® Mfd. for Meitheal Pharmaceuticals Chicago, IL 60631 (USA) ©2026 Meitheal Pharmaceuticals Inc.

Mfd. by Hong Kong King-Friend Industrial Company Limited Hong Kong, China 999077 Product of Ireland XENLETA is a trademark of Emerge Bioscience Pte. Ltd. For patent information: https://www.meithealpharma.com/our-products… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Following single-dose intravenous administration, the AUC of lefamulin increased approximately dose-proportionally while the C max of lefamulin increased less than dose-proportionally over a dose range of 25 mg (0.17 times the approved dose) to 400 mg (2.67 times the approved dose). Following single-dose oral administration, the AUC of lefamulin increased more than dose proportionally over a dose range of 500 mg (0.8 times the approved dose) to 750 mg (1.25 times the approved dose). Pharmacokinetic (PK) parameters of lefamulin following administration of XENLETA Injection or Tablets to patients with CABP are listed in Table 4 .

The mean lefamulin AUC 0-24h and C max in patients with CABP were 73% and 30% higher, respectively, compared with healthy subjects. Table 4: Pharmacokinetic (PK) Parameters of Lefamulin Following Single or Multiple Dose (Every 12 Hours) XENLETA Administered as 150 mg (Infused Over 60 Minutes) Intravenously (IV) or 600 mg Orally in Patients with CABP a a Based on population PK modeling (Trial 1 for IV administration and Trial 2 for oral administration) b C max =maximum plasma concentration; C min =trough plasma concentration; AUC 0–24h =area under the plasma concentration-time curve from time zero to 24 hours c Dose administered under fasting conditions (1 hour before or 2 hours after a meal) PK Parameters b Administration Route Arithmetic Mean (% CV) Day 1 Steady State C max (mcg/mL) IV 3.50 (11.7) 3.60 (14.6) Oral c 2.24 (36.4) 2.24 (37.1) C min (mcg/mL) IV 0.398 (68.1) 0.573 (89.4) Oral c 0.593 (67.3) 0.765 (75.7) AUC 0-24h (mcg·h/mL) IV 27.0 (31.8) 28.6 (46.9) Oral c 30.7 (45.0) 32.7 (49.2) Absorption The mean oral bioavailability of XENLETA Tablets is approximately 25% and peak lefamulin plasma concentration occurred 0.88 to 2 hours after administration to healthy subjects.

Effect of Food The concomitant administration of a single oral dose of 600 mg XENLETA Tablets with a high fat (approximately 50% of total calories from fat), high calorie breakfast (approximately 800-1000 calories) slightly reduced bioavailability. The mean relative reduction for oral XENLETA (fasted vs. fed) was on average 22.9% [90% CI: 12.2; 32.3] for the C max and 18.43% [90% CI: 11.7; 24.7] for the AUC 0-inf . Distribution Mean plasma protein binding of lefamulin ranges from 94.8% at 2.35 mcg/mL to 97.1% at 0.25 mcg/mL in healthy adults.

The mean (min to max) steady state volume of distribution of lefamulin is

86.1L (34.2 to 153 L) in patients with CABP after administration of XENLETA Injection. Following a single IV administration of lefamulin 150 mg to healthy subjects, the highest lefamulin epithelial lining fluid (ELF) concentrations were observed at the end of infusion. The mean ELF and plasma AUC 0-8 was 3.87 mcg·h/mL and 5.27 mcg·h/mL, respectively.

The estimated ratio of ELF AUC to unbound plasma AUC is approximately 15. Elimination The mean (min to max) total body clearance of lefamulin is

11.9L/h (2.94 to

30.0L/h) in patients with CABP after XENLETA Injection administration. The mean (min to max) elimination half-life of lefamulin is approximately 8 hours (3 to 20 h) in patients with CABP. Metabolism Lefamulin is primarily metabolized by CYP3A4.

Excretion In healthy adult subjects, the mean % of total radioactivity excreted in feces was 77.3% (4.2% to 9.1% unchanged) and 88.5% (7.8% to 24.8% unchanged), and in urine was 15.5% (9.6% to 14.1% unchanged) and 5.3% (unchanged not determined) following 150 mg IV or 600 mg oral XENLETA, respectively. Specific Populations No clinically significant differences in the pharmacokinetics of XENLETA were observed based on age, sex, race, weight, or renal impairment including patients receiving hemodialysis. Patients with Hepatic Impairment The disposition of lefamulin was evaluated in non-infected subjects with normal hepatic function and with moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment following administration of XENL… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 183 words ▾

12.2Pharmacodynamics The 24 h free-drug AUC to minimal inhibitory concentration (MIC) ratio has been shown to be the best Pharmacokinetic-Pharmacodynamic (PK-PD) index for the antibacterial activity of lefamulin in animal infection models of Streptococcus pneumoniae and Staphylococcus aureus pneumonia. Cardiac Electrophysiology The QTcF interval prolongation risk of XENLETA was evaluated using 2 randomized, double-blind, double-dummy, active controlled (moxifloxacin 400 mg once daily), parallel group, trials (Trials 1 and 2) in adult patients with CABP.

A concentration dependent QTc prolongation effect of XENLETA was observed. The mean change from baseline QTcF (90% two-sided upper confidence interval) values around T max on day 3 or 4 were 13.6 ms (15.5 ms) for 150 mg injection administered twice daily as infusion and 9.3 ms (10.9 ms) for 600 mg tablet administered twice daily. The mean change from baseline QTcF (90% two-sided upper confidence interval) values around T max for the moxifloxacin randomized comparison arm on day 3 or 4 were 16.4 ms (18.3 ms) for 400 mg injection administered once daily as infusion and 11.6 ms (13.2 ms) for 400 mg tablet administered once daily.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Community-Acquired Bacterial Pneumonia A total of 1289 adults with CABP were randomized in two multicenter, multinational, double‑blind, double‑dummy, non-inferiority trials (Trial 1 NCT #02559310 and Trial 2 NCT #02813694). Trial 1 compared 5 to 10 days of XENLETA to 7 to 10 days of moxifloxacin ± linezolid. Trial 2 compared 5 days of XENLETA to 7 days of moxifloxacin.

In Trial 1, 276 patients were randomized to XENLETA (150 mg by intravenous [IV] infusion over 60 minutes every 12 hours, with the option to switch to 600 mg orally every 12 hours after at least 3 days of IV treatment) and 275 patients were randomized to moxifloxacin (400 mg IV every 24 hours, with the option to switch to 400 mg orally every 24 hours after at least 3 days of IV treatment). If methicillin-resistant Staphylococcus aureus (MRSA) was suspected at screening, patients randomized to moxifloxacin were to receive adjunctive linezolid (600 mg IV every 12 hours, with the option to switch to 600 mg orally every 12 hours after at least 3 days of IV treatment), and patients randomized to XENLETA were to receive linezolid placebo.

Patients were predominantly male (60%) and white (87%). Approximately 72% of patients were PORT Risk Class III and 28% were PORT Risk Class IV or V. Median age was 62 (range 19-91) years, approximately 18% of patients were 75 years or older, and median body mass index (BMI) was 25.8 (range 11-58.4) kg/m 2 .

Approximately 53% of patients had creatinine clearance (CrCl) <90 mL/min. Common comorbid conditions included hypertension (41%), asthma/chronic obstructive pulmonary disease (COPD) (17%), and diabetes mellitus (13%). In Trial 2, 370 patients were randomized to XENLETA (600 mg orally every 12 hours for 5 days) and 368 patients were randomized to moxifloxacin (400 mg orally every 24 hours for 7 days).

Patients were predominantly male (52%) and white (74%). Approximately 50% of patients were PORT Risk Class II and 49% were PORT Risk Class III or IV. Median age was 59 (range 19-97) years, approximately 16% of patients were 75 years or older, and median BMI was 26.0 (range 13-63.9) kg/m 2 .

Approximately 50% of patients had CrCl <90 mL/min. Common comorbid conditions included hypertension (36%), asthma/COPD (16%), and diabetes mellitus (13%). In both trials, efficacy was determined by Early Clinical Response (ECR) at 72 to 120 hours after the first dose in the Intent-to-treat (ITT) Analysis Set, which comprised all randomized patients.

Patients entered the trials with at least three of four symptoms consistent with CABP (cough, sputum production, chest pain, and/or dyspnea). Response was defined as survival with improvement of at least two symptoms, no worsening of any symptom, and no receipt of non-study antibacterial treatment for CABP. Table 5 summarizes ECR rates in the two trials.

Table 5: Early Clinical Response Rates in Trial 1 and Trial 2 (ITT Analysis Set) *Trial 1 compared XENLETA to moxifloxacin ± linezolid. **95% confidence interval for the treatment difference. Study XENLETA n/N (%) Moxifloxacin n/N (%)* Treatment Difference (95% CI)** Trial 1 241/276 (87.3) 248/275 (90.2) -2.9 (-8.5, 2.8) Trial 2 336/370 (90.8) 334/368 (90.8) 0.1 (-4.4, 4.5) Clinical response was also assessed by the Investigator at the Test of Cure (TOC) Visit 5 to 10 days after the last dose of study drug. Response was defined as survival with improvement of signs and symptoms based on the Investigator’s assessment and no receipt of non-study antibacterial treatment for CABP.

Table 6 summarizes Investigator-assessed Clinical Response (IACR) rates at TOC in the ITT Analysis Set, which comprised all randomized patients. Table 6: Investigator-assessed Clinical Response Rates at TOC in Trial 1 and Trial 2 (ITT Analysis Set) *Trial 1 compared XENLETA to moxifloxacin ± linezolid. **95% confidence interval for the treatment difference. Study XENLETA n/N (%) Moxifloxacin n/N (%)* Treatment Difference (95% CI)** Trial 1 223/276 (80.8) 2… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenicity studies have not been conducted with lefamulin. Lefamulin did not elicit genotoxic potential in an in vivo rat bone marrow micronucleus assay for clastogenicity or in the in vitro Mouse Lymphoma Ly5178Y TK+/- mutation assay. The main human metabolite of lefamulin (2 R -hydroxy lefamulin) also did not elicit genotoxic potential in the in vitro Mouse Lymphoma Ly5178Y TK+/- mutation assay.

In rats, there were no effects on male fertility that were considered to be related to lefamulin. Reproductive indices including mating behavior and fertility were not changed in any group in either gender at the highest dose tested (75 mg/kg/day, approximately 0.7 times the mean exposure of CABP patients treated IV, based on AUC 0-24h ); that dose was the NOAEL for fertility in male rats. In females, abnormal estrous cycling and increased post-implantation loss were observed at the high dose, making the NOAEL for fertility and early embryonic development in female rats the next highest dose, 50 mg/kg/day (approximately 0.5 times the mean exposure of CABP patients treated IV).

13.2Animal Toxicology and/or Pharmacology Following IV administration of lefamulin to rats for 4 or 13 weeks, anemia (all doses), increased coagulation times, and lower organ weights and histopathological changes in spleen (decreased peri-arteriolar lymphoid sheath, decreased size of the marginal zone) and thymus (cortical atrophy) were seen in rats at exposures greater than approximately 0.7 times exposure in CABP patients after IV administration in the 4-week study and greater than approximately 0.3 times exposure in CABP patients in the 13-week study.

In cynomolgus monkeys administered IV lefamulin, anemia and pancreatic microvesicular vacuolization of acinar cells were noted at exposures greater than approximately 1.6 times exposure in CABP patients in a 4-week study. In a 13-week study, pancreatic microvesicular vacuolization of acinar cells and minimal alveolar macrophage infiltrates in the lung were observed at all doses, and anemia was noted at exposures greater than approximately 1.0 times clinical exposure. Lefamulin was evaluated in 4-week oral toxicology studies in rats and cynomolgus monkeys.

Findings included partially reversible degenerative changes in the stomach and evidence of lymphoid depletion and hematopoietic cell depletion in rats at exposures greater than approximately 0.6 times exposure following oral administration to CABP patients. Findings in cynomolgus monkeys included myocardial vacuolation and fibrosis at exposures equal to or greater than 0.3 times that in CABP patients. Evidence of dose-dependent regenerative anemia in both species may indicate that XENLETA was potentially hemolytic at a concentration that is approximately ten times higher than the concentration of the infusion solution which will be used clinically.

This effect was not apparent from an in vitro evaluation of blood compatibility using human blood at a concentration of 0.6 mg/mL.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 179 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenicity studies have not been conducted with lefamulin. Lefamulin did not elicit genotoxic potential in an in vivo rat bone marrow micronucleus assay for clastogenicity or in the in vitro Mouse Lymphoma Ly5178Y TK+/- mutation assay. The main human metabolite of lefamulin (2 R -hydroxy lefamulin) also did not elicit genotoxic potential in the in vitro Mouse Lymphoma Ly5178Y TK+/- mutation assay.

In rats, there were no effects on male fertility that were considered to be related to lefamulin. Reproductive indices including mating behavior and fertility were not changed in any group in either gender at the highest dose tested (75 mg/kg/day, approximately 0.7 times the mean exposure of CABP patients treated IV, based on AUC 0-24h ); that dose was the NOAEL for fertility in male rats. In females, abnormal estrous cycling and increased post-implantation loss were observed at the high dose, making the NOAEL for fertility and early embryonic development in female rats the next highest dose, 50 mg/kg/day (approximately 0.5 times the mean exposure of CABP patients treated IV).

📄 Package Label / Principal Display Panel ~2 min read ▾

PACKAGE LABEL PRINCIPAL DISPLAY PANEL - XENLETA ® (lefamulin) injection Vial Label NDC 71288-039-15 Rx only XENLETA ® (lefamulin) injection 150 mg/15 mL Equivalent to 10 mg/mL lefamulin Each vial contains 168 mg lefamulin acetate equivalent to 150 mg lefamulin Single-dose Vial • Sterile, non-pyrogenic FOR INTRAVENOUS INFUSION ONLY WARNING! Concentrated solution. Must dilute before use.

Dilute 15 mL concentrate in 250 mL of 10 mM citrate buffered 0.9% sodium chloride for injection provided by Meitheal. PACKAGE LABEL PRINCIPAL DISPLAY PANEL - XENLETA (lefamulin) injection Vial Label

PACKAGE LABEL PRINCIPAL DISPLAY PANEL - XENLETA ® (lefamulin) injection Carton NDC 71288-039-16 6 Single-Dose Vials Rx only XENLETA ® (lefamulin) injection 150 mg/15 mL Equivalent to 10 mg/mL lefamulin Each vial contains 168 mg lefamulin acetate equivalent to 150 mg lefamulin Sterile, non-pyrogenic FOR INTRAVENOUS INFUSION ONLY WARNING! Concentrated solution. Must dilute before use.

Dilute 15 mL concentrate in 250 mL of 10 mM citrate buffered 0.9% sodium chloride for injection provided by Meitheal. PACKAGE LABEL PRINCIPAL DISPLAY PANEL - XENLETA (lefamulin) injection Carton

PACKAGE LABEL PRINCIPAL DISPLAY PANEL - XENLETA ® (lefamulin) injection Diluent Bag Label 250 mL Rx only NDC 71288-040-64 DILUENT FOR XENLETA ® (LEFAMULIN) INJECTION 10 mM CITRATE BUFFERED 0.9% SODIUM CHLORIDE INJECTION ONLY AFTER ADDING XENLETA - INFUSE OVER 60 MINUTES PACKAGE LABEL PRINCIPAL DISPLAY PANEL - XENLETA (lefamulin) injection Diluent Bag Label

PACKAGE LABEL PRINCIPAL DISPLAY PANEL - XENLETA ® (lefamulin) injection Diluent Bag Carton NDC 71288-040-65 6 Single-dose IV Bags x 250 mL Rx only DILUENT FOR XENLETA ® (LEFAMULIN) INJECTION 10 mM Citrate Buffered 0.9% Sodium Chloride Injection Sterile, non-pyrogenic FOR INTRAVENOUS INFUSION ONLY WARNING! For dilution of XENLETA (LEFAMULIN) INJECTION only. Infuse over 60 minutes.

PACKAGE LABEL PRINCIPAL DISPLAY PANEL - XENLETA (lefamulin) injection Diluent Bag Carton

PACKAGE LABEL PRINCIPAL DISPLAY PANEL - XENLETA ® (lefamulin) tablets, 10-Pack Blister Package NDC 71288-037-10 10 Tablets Rx only XENLETA ® (lefamulin) tablets 600 mg Each tablet contains 671 mg lefamulin acetate equivalent to 600 mg lefamulin 10-Count Oral Pack PACKAGE LABEL PRINCIPAL DISPLAY PANEL - XENLETA® (lefamulin) tablets, 10-Pack Blister Package

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

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 Xenleta (this brand).

Top reported reactions

Diarrhoea7
Vomiting4
Nausea3
Abdominal Discomfort2
Palpitations2
Pneumonia2
Abdominal Pain Upper1

Age at onset

Adult1
Elderly1

Reporter sex

17 reports
Male · 60%
Female · 40%

Serious outcomes

Hospitalization1
Death1
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 8 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
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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
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Orange Book / therapeutic-equivalence data ✓ Available
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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.
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Where does this data come from?
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← 71288-0035-52 · Meitheal 71288-0039-16 · Meitheal →
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