Home › NDC Lookup › Ingredients › Moxidectin › 71705-0050-01
Moxidectin 2 mg Tablet, 500-count — NDC 71705-0050-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Moxidectin 2 mg Tablet, 500-count — NDC 71705-050-01 (Billing 71705-0050-01)

by Medicines Development for Global Health · 500 TABLET in 1 BOTTLE, PLASTIC

This is a package of 500 tablets of Moxidectin 2 mg Tablet from Medicines Development for Global Health, marketed since Dec 2019 and currently FDA-listed. It is this product's only package size.

NDC 71705-0050-01
🏷️ FDA NDC (as labeled) 71705-050-01 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 Aug 13, 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 71705-050-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
71705 labeler · 050 product · 01 package
Package marketed since
Dec 2, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0371705050011
FDA record last changed
Aug 13, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71705-050-01
Product NDC 71705-050
11-digit billing NDC 71705005001
RxCUI 2049015
UNII NGU5H31YO9
UPC 0371705050011
Application # NDA210867
SPL Set ID 6eb02ae9-9065-176f-e053-2991aa0ac891
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-12-02
Route ORAL
Dosage form TABLET
Substance MOXIDECTIN
Quick answers
  • RxCUI (RxNorm): 2049015
Why two NDCs? The FDA registers this code as 71705-050-01 — 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 → 71705-0050-01. 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 Other antinematodals class.

Drug family (ATC) Other antinematodals
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

📗 Our plain-language guide HelloPharmacist
  • Moxidectin treats onchocerciasis — also called river blindness — which is a parasitic infection caused by a worm called Onchocerca volvulus. It works by targeting the immature worm...
  • What exactly does moxidectin treat, and how does it work?
  • It's a one-time, single dose — you don't take it daily or on a regular schedule. You'll take a certain number of tablets based on your body weight, all at once. Just take them as d...
  • Do I take this every day, or is it a one-time thing?
📖 Read our full Moxidectin guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer 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
71705-0050-01 You're viewing this Main listing 500 TABLET in 1 BOTTLE, PLASTIC 2019-12-02 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Moxidectin 2 mgthis 71705-0050-01 Medicines 500 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

🏛️
2018
First FDA approval
Jun 2018
📍
2026
Currently FDA-listed
8 years listed
🛡️
2032
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 Feb 2032. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jun 13, 2018 RLD RS ⏳ ~5.3 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
Exclusivity NPP
Exclusivity ODE-528
2018 2020 2022 2024 2026 2028 2030 2032
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.

FDA exclusivity
CodeWhat it grantsExpires
NPPNew Patient PopulationFeb 7, 2028
ODE-528Orphan Drug Exclusivity (7-year)Feb 7, 2032
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 Feb 2032 — 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 white
ShapeOval
ImprintAKKA
Size8 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.

🧪 Avoiding an ingredient? See Moxidectin inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • 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 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 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.

6 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

LabelerMedicines Development for Global Health
Application holderMEDICINES DEVELOPMENT FOR GLOBAL HEALTH
FDA applicationNDA210867 (NDA)
Labeler code71705
First marketedDec 2019
Product typeHuman Prescription Drug
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 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 155 words ▾

1 INDICATIONS AND USAGE Moxidectin Tablets are indicated for the treatment of onchocerciasis due to Onchocerca volvulus in adult and pediatric patients aged 4 years and older and weighing at least 13 kg [see Clinical Studies ( 14 )] . Limitations of Use: Moxidectin Tablets does not kill adult Onchocerca volvulus (O. volvulus) parasites . Follow-up evaluation is advised.

The safety and efficacy of repeat administration of Moxidectin Tablets in patients with O . volvulus has not been studied. Moxidectin is an anthelmintic indicated for the treatment of onchocerciasis due to Onchocerca volvulus in adults and pediatric patients aged 4 years and older and weighing at least 13 kg. ( 1 ) Limitations of Use: Moxidectin Tablets do not kill adult Onchocerca volvulus (O. volvulus) parasites.

Follow-up is advised. ( 1 ) The safety and efficacy of repeat administration of Moxidectin Tablets in patients with O . volvulus has not been studied. ( 1 )

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION Recommended Dosage in Adult Patients : Take 8 mg (four 2 mg tablets) as a single oral dose, with or without food. ( 2.1 ) Recommended Dosage in Pediatric P atients (4 Years of Age and Older and Weighing at Least 13 kg): See Table below. ( 2.2 ) Body Weight Dose Number of 2 mg Tablets 13 kg to less than 15 kg 4 mg 2 15 kg to less than 30 kg 6 mg 3 Greater than or equal to 30 kg 8 mg 4

2.1Recommended Dosage in Adult Patients The recommended dosage of Moxidectin Tablets in adult patients is a single dose of 8 mg (four 2 mg tablets) taken orally with or without food [see Clinical Pharmacology ( 12.3 )]. 2. 2 Recommended Dosage in Pediatric Patients (4 Years of Age and Older and Weighing at Least 13 kg) The recommended dosage of Moxidectin Tablets in pediatric patients aged 4 years and older and weighing at least 13 kg is described in Table 1 below.

Administer Moxidectin Tablets as a single dose taken orally with or without food [see Clinical Pharmacology ( 12.3 ) ]. Table 1: Recommended Dosage of Moxidectin Tablets in Pediatric Patients 4 Years of Age and Older and Weighing at Least 13 kg Body Weight Dose Number of 2 mg Tablets 13 kg to less than 15 kg 4 mg 2 15 kg to less than 30 kg 6 mg 3 Greater than or equal to 30 kg 8 mg 4

💊 Dosage Forms and Strengths 31 words ▾

3 DOSAGE FORMS AND STRENGTHS Moxidectin Tablets: 2 mg of moxidectin, white to pale yellow, uncoated, oval-shaped, debossed on one side with “AKKA”. Tablets: 2 mg of moxidectin. ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Cutaneous, Ophthalmological and/or Systemic Adverse Reactions of Varying Severity (Mazzotti Reaction ) : This may occur in patients with onchocerciasis following treatment with Moxidectin Tablets. Monitor patients for symptoms, including symptomatic orthostatic hypotension. ( 5.1 ) Symptomatic Orthostatic Hypotension : Episodes of symptomatic orthostatic hypotension including inability to stand without support may occur in patients following treatment with Moxidectin Tablets.

( 5.2 ) Encephalopathy in Loa loa C o- I nfected P atients : Serious or even fatal encephalopathy following treatment with Moxidectin Tablets may occur in patients co-infected with Loa loa . Assess patients for loiasis in Loa loa endemic areas prior to treatment. ( 5.3 ) Edema and Worsening of Onchodermatitis : Patients with hyper-reactive onchodermatitis (sowda) may be more likely than others to experience severe edema and aggravation of onchodermatitis.

( 5.4 )

5.1Cutaneous, Ophthalmological and/or Systemic Adverse Reactions Treatment with Moxidectin Tablets may cause cutaneous, ophthalmological and/or systemic reactions of varying severity (Mazzotti reaction). These adverse reactions are due to allergic and inflammatory host responses to the death of microfilariae [see Adverse Reactions ( 6.1 )]. There is a trend toward an increased incidence of these adverse reactions in patients with higher microfilarial burden.

The clinical manifestations of Mazzotti reaction include pruritus, headache, pyrexia, rash, urticaria, hypotension (including symptomatic orthostatic hypotension and dizziness) [ see Warnings and Precautions ( 5.2 )] , tachycardia, edema, lymphadenopathy, arthralgia, myalgia, chills, paresthesia and asthenia. Ophthalmological manifestations include conjunctivitis, eye pain, eye pruritus, eyelid swelling, blurred vision, photophobia, changes in visual acuity, hyperemia, ocular discomfort and watery eyes. These adverse reactions generally occur and resolve in the first week post-treatment.

Laboratory changes include eosinophilia, eosinopenia, lymphocytopenia, neutropenia, and increases in alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transferase (GGT) and lactate dehydrogenase (LDH). Proteinuria has also been reported. Treatment of severe Mazzotti reactions has not been evaluated in controlled clinical trials.

Symptomatic treatments such as oral hydration, recumbency, intravenous normal saline, and/or parenteral corticosteroids have been used to treat orthostatic hypotension. Antihistamines and/or analgesics have been used for most mild to moderate cases.

5.2Symptomatic Orthostatic Hypotension An increased number of patients who received Moxidectin Tablets developed symptomatic orthostatic hypotension with inability to stand without support after lying down for 5 minutes (in an orthostatic hypotension provocation test); 47/978 (5%) compared with 8/494 (2%) who received ivermectin. The decreases in blood pressure were transient, managed by resumption of recumbency and most commonly occurred on Days 1 and 2 post-treatment. Advise patients that if they feel dizzy or light-headed after taking Moxidectin Tablets, they should lie down until the symptoms resolve.

5.3Encephalopathy in Loa loa Co - infected Patients Patients with onchocerciasis who are also infected with Loa loa may develop a serious or even fatal encephalopathy following treatment with Moxidectin Tablets. Moxidectin Tablets have not been studied in patients co-infected with Loa loa . Therefore, it is recommended that individuals who warrant treatment with Moxidectin Tablets and have had exposure to Loa loa -endemic areas undergo diagnostic screening for loiasis prior to treatment.

5.4Edema and Worsening of Onchodermatitis Patients with hyper-reactive onchodermatitis (sowda) may be more likely than others to experience severe edema and worsening of onchodermatitis following the use of Moxidectin Tablets. Symptomatic treat… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described in greater detail in other labeling sections: Cutaneous, Ophthalmological and/or Systemic Adverse Reactions [see Warnings and Precautio ns ( 5.1 )] Symptomatic Orthostatic Hypotension [see Warnings and Precautions ( 5.2 )] Encephalopathy in Loa loa Co-infected Patients [see Warnings and Precautions ( 5.3 )] Edema and Worsening of Onchodermatitis [see Warnings and Precautions ( 5.4 )] The most common adverse reactions (incidence > 10%) in adult and pediatric patients (12 to less than 18 years of age) in Trial 1 were eosinophilia, pruritus, musculoskeletal pain, headache, lymphocytopenia, tachycardia, rash, abdominal pain, hypotension, pyrexia, leukocytosis, influenza-like illness, neutropenia, cough, diarrhea/gastroenteritis/enteritis, lymph node pain, dizziness, hyponatremia and peripheral swelling.

( 6.1 ) The most common adverse reactions (incidence > 5%) in pediatric patients (4 to less than 18 years of age) in Trial 3 were abdominal pain and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Medicines Development for Global Health at 1-800-MDGH-456 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under varying controlled conditions, adverse reaction rates observed in one clinical trial cannot be directly compared to rates observed in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Clinical Trials Experience in Adults and Pediatric Patients (12 Years to Less than 18 Years of Age) The safety of Moxidectin Tablets was evaluated in two randomized, double-blind, active-controlled studies in patients with confirmed onchocerciasis (Trial 1 and Trial 2) [see Clinical Studies ( 14 )] .

In Trial 1, 978 patients (including 53 pediatric patients aged 12 to less than 18 years) received Moxidectin Tablets as a single oral dose of 8 mg and 494 patients received ivermectin (including 24 pediatric patients aged 12 to less than 18 years) as a single oral dose of approximately 150 mcg/kg. In Trial 2, 127 patients aged 18 years or older received Moxidectin Tablets as a single oral dose ranging from 2 mg (this is not an approved dose) to 8 mg (38 received the recommended 8 mg dose) and 45 patients aged 18 years or older received ivermectin as a single oral dose of approximately 150 mcg/kg.

Most Common Adverse Reactions No patients withdrew from either trial due to adverse reactions. Adverse Reactions reported in Trial 1 in > 10% of patients are summarized in Table 2. Most were related to physical, vital signs and laboratory changes associated with Mazzotti reaction [see Warnings and Precautions ( 5.1 )] .

Table 2: Adverse Reactions Occurring in > 10% of Moxidectin-treated Patients with Onchocerciasis in Trial 1 Adverse Reaction Moxidectin N = 978 n (%) Ivermectin N = 494 n (%) Eosinophilia 721 (74) 390 (79) Pruritus 640 (65) 268 (54) Musculoskeletal pain a 623 (64) 257 (52) Headache 566 (58) 267 (54) Lymphocytopenia* 470 (48) 215 (44) Tachycardia b 382 (39) 148(30) Orthostatic tachycardia c 333 (34) 130 (26) Non-orthostatic tachycardia d 179 (18) 57 (12) Rash e 358 (37) 103 (21) Abdominal pain f 305 (31) 173 (35) Hypotension g 289 (30) 125 (25) Orthostatic hypotension h 212 (22) 81 (16) Pyrexia/Chills 268 (27) 88 (18) Leukocytosis 240 (25) 125 (25) Influenza like illness 226 (23) 102 (21) Neutropenia** 197 (20) 112 (23) Cough 168 (17) 88 (18) Lymph node pain 129 (13) 28 (6) Dizziness 121 (12) 44 (9) Diarrhea/Gastroenteritis/Enteritis 144 (15) 84 (17) Hyponatremia 112 (12) 65 (13) Peripheral swelling 107 (11) 30 (6) a Includes “myalgia”, “arthralgia”, “musculoskeletal pain”, “pain” and “back pain” b Includes “orthostatic heart rate increased”, “postural orthostatic tachycardia syndrome”, “heart rate increased” and “sinus tachycardia” c Includes “orthostatic heart rate increased” and “postural orthostatic tachycardia syndrome”… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 47 words ▾

7 DRUG INTERACTIONS

7.1Midazolam (CYP3A4 substrate) In healthy subjects, concomitant administration of a single 8 mg oral dose of Moxidectin Tablets did not have an effect on the pharmacokinetics of midazolam [ see Clinical Pharmacology ( 12.3 ) ]. Moxidectin can be co-administered with CYP3A4 substrates.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation : Breastfeeding is not recommended during treatment with Moxidectin Tablets and for 7 days after treatment. ( 8.2 )

8.1Pregnancy Risk Summary Available data from clinical trials on the use of Moxidectin Tablets in pregnant women are insufficient to establish whether there is a moxidectin-associated risk for major birth defects and miscarriage . Moxidectin administered orally to pregnant rats during the period of organogenesis was not associated with significant embryo-fetal developmental effects at doses of approximately 15 times the recommended human dose based on body surface area (BSA) comparison. When moxidectin was dosed orally to pregnant rabbits during the period of organogenesis, no embryo-fetal developmental effects were observed at oral doses of moxidectin up to 24 times the recommended human dose based on BSA comparison ( see Data ) .

Daily administration of moxidectin by oral gavage to maternal female rats during organogenesis and through lactation was associated with decreased survival, adverse clinical signs, and decreased body weights in first-generation offspring during the lactation period at a moxidectin dose less than 2-times the recommended human dose based on BSA comparison. Additional findings in first-generation offspring at the same dose included delays in pinna unfolding, eye opening, and vaginal opening. Other parameters, including reproduction and neurological development in first-generation offspring were not affected at any moxidectin dose ( 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.

Data Animal Data In a rat embryo-fetal development study, daily oral administration of moxidectin at 12 mg/kg/day (approximately 15 times the recommended human dose of 8 mg based on BSA comparison) during Gestation Days (GDs) 6 to 15 significantly increased the fetal incidence, but not the litter incidence of cleft palate and the fetal and litter incidence of a skeletal variation, wavy ribs, at a maternally toxic dose. Mean maternal food consumption, body weights, and body weight gain were significantly decreased at moxidectin doses of 10 and 12 mg/kg/day compared to control values.

The no observed adverse effect level (NOAEL) value for maternal and fetal toxicity was considered to be 5 and 10 mg/kg/day respectively (approximately 6 and 12 times, respectively, the recommended human dose based on BSA comparison). In the rabbit, daily oral administration of moxidectin at ≥ 5 mg/kg/day from GD 7 to GD 19 was not associated with fetal weight loss or malformations but resulted in significantly decreased maternal food consumption and body weight gains. The NOAEL values for maternal and fetal toxicity in the rabbit was 1 mg/kg/day and 10 mg/kg/day respectively (approximately 2 times and 24 times, respectively, the recommended human dose based on BSA comparison).

In a pre-postnatal study, moxidectin doses of 0.2 and 0.5 mg/kg/day were administered by oral gavage to maternal female rats from GD 6 throughout the lactation period until LD 21. A third dose group that received maternal doses of 1.5 mg/kg/day moxidectin (less than 2-times the recommended human dose based on BSA comparison) was divided into two cohorts with Cohort 1 receiving maternal doses from GD 6 until LD 10 and Cohort 2 receiving maternal doses from GD 6 until each individual animal littered, but not during the lactation period.

First-generation offspring in Cohort 1 had adverse clinical signs (small body size, thin, weak, subdued/sluggish, pale, cold to touch, respiratory distress, blue coloration and/or no visible milk in stomach) and decreased survival and body weights during t… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Available data from clinical trials on the use of Moxidectin Tablets in pregnant women are insufficient to establish whether there is a moxidectin-associated risk for major birth defects and miscarriage . Moxidectin administered orally to pregnant rats during the period of organogenesis was not associated with significant embryo-fetal developmental effects at doses of approximately 15 times the recommended human dose based on body surface area (BSA) comparison. When moxidectin was dosed orally to pregnant rabbits during the period of organogenesis, no embryo-fetal developmental effects were observed at oral doses of moxidectin up to 24 times the recommended human dose based on BSA comparison ( see Data ) .

Daily administration of moxidectin by oral gavage to maternal female rats during organogenesis and through lactation was associated with decreased survival, adverse clinical signs, and decreased body weights in first-generation offspring during the lactation period at a moxidectin dose less than 2-times the recommended human dose based on BSA comparison. Additional findings in first-generation offspring at the same dose included delays in pinna unfolding, eye opening, and vaginal opening. Other parameters, including reproduction and neurological development in first-generation offspring were not affected at any moxidectin dose ( 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.

Data Animal Data In a rat embryo-fetal development study, daily oral administration of moxidectin at 12 mg/kg/day (approximately 15 times the recommended human dose of 8 mg based on BSA comparison) during Gestation Days (GDs) 6 to 15 significantly increased the fetal incidence, but not the litter incidence of cleft palate and the fetal and litter incidence of a skeletal variation, wavy ribs, at a maternally toxic dose. Mean maternal food consumption, body weights, and body weight gain were significantly decreased at moxidectin doses of 10 and 12 mg/kg/day compared to control values.

The no observed adverse effect level (NOAEL) value for maternal and fetal toxicity was considered to be 5 and 10 mg/kg/day respectively (approximately 6 and 12 times, respectively, the recommended human dose based on BSA comparison). In the rabbit, daily oral administration of moxidectin at ≥ 5 mg/kg/day from GD 7 to GD 19 was not associated with fetal weight loss or malformations but resulted in significantly decreased maternal food consumption and body weight gains. The NOAEL values for maternal and fetal toxicity in the rabbit was 1 mg/kg/day and 10 mg/kg/day respectively (approximately 2 times and 24 times, respectively, the recommended human dose based on BSA comparison).

In a pre-postnatal study, moxidectin doses of 0.2 and 0.5 mg/kg/day were administered by oral gavage to maternal female rats from GD 6 throughout the lactation period until LD 21. A third dose group that received maternal doses of 1.5 mg/kg/day moxidectin (less than 2-times the recommended human dose based on BSA comparison) was divided into two cohorts with Cohort 1 receiving maternal doses from GD 6 until LD 10 and Cohort 2 receiving maternal doses from GD 6 until each individual animal littered, but not during the lactation period.

First-generation offspring in Cohort 1 had adverse clinical signs (small body size, thin, weak, subdued/sluggish, pale, cold to touch, respiratory distress, blue coloration and/or no visible milk in stomach) and decreased survival and body weights during the lactation period. However, first-generation offspring in Cohort 2 did not experience adverse clinical signs, body weight loss, or reduced survival sugges… [Excerpted — this section continues on DailyMed.]

🧒 Pediatric Use 122 words ▾

8.4Pediatric Use The safety and effectiveness of Moxidectin Tablets for the treatment of onchocerciasis due to O. volvulus have been established in pediatric patients aged 4 years and older and weighing at least 13 kg. Use of Moxidectin Tablets for this indication is supported by evidence from adequate and well controlled studies in adult and pediatric patients aged 12 years and older with additional pharmacokinetics (PK) and safety data in pediatric patients aged 4 years and older [see Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ), and Clinical Studies ( 14 )] .

The safety and effectiveness of Moxidectin Tablets in pediatric patients younger than 4 years of age or weighing less than 13 kg has not been established.

🧓 Geriatric Use 81 words ▾

8.5Geriatric Use Of the total number of patients included in Trial 1 that were treated with Moxidectin Tablets, 83 were aged 65 and over. No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out [see Clinical Studies ( 14 ) and Clinical Pharmacology ( 12.3 )] .

🆘 Overdosage 78 words ▾

10 OVERDOSAGE No specific antidote is available for overdose with Moxidectin Tablets. If overdose occurs, the patient should be monitored for evidence of toxicity. Treatment of overdose with Moxidectin Tablets consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.

Supportive therapy, if indicated, should include parenteral fluids and electrolytes, respiratory support (oxygen and mechanical ventilation if necessary) and pressor agents if clinically significant hypotension is present.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Moxidectin, a macrocyclic lactone, is an anthelmintic drug [see Microbiology ( 12.4 )] .

12.2Pharmacodynamics Cardiac Electrophysiology At a dose 4.5 times the approved recommended dose, moxidectin does not prolong the QT interval to any clinically relevant extent.

12.3Pharmacokinetics The pharmacokinetic parameters of moxidectin following a single 8 mg oral dose of Moxidectin Tablets to healthy subjects and patients with onchocerciasis under fasted conditions are shown in Table 5. Mean moxidectin C max and AUC increased approximately proportionally to dose over a dose range of 2 to 36 mg (0.25 to 4.5 times the approved recommended dose) in healthy subjects under fasted conditions. Table 5: Mean (± SD) Pharmacokinetic Parameters of Moxidectin Following a Single 8 mg Oral Dose of Moxidectin Tablets to Healthy Subjects and Patients with Onchocerciasis Under Fasted Conditions PK Parameter Healthy Subjects (N = 27 ) Patients with Onchocerciasis (N = 3 1 ) C max (ng/mL) 58.9 ± 12.5 63.1 ±

20.0T max * (hours) 4 (2, 8) 4 (1, 4) AUC inf (ng•h/mL) 3387 ± 1328 2738 ± 1606 Half-life (hours) 784 ± 347 559 ± 525 C max = maximum plasma concentration; T max = time to reach C max ; AUC inf = area under the plasma concentration-time curve from time 0 to infinity; * Median (range) Absorption Effect of Food Moxidectin mean C max and AUC increased on average by 34% and 39%, respectively, when administered with a standard high fat meal (900 calories, with a nutritional distribution of approximately 55% fat, 31% carbohydrates and 14% protein), compared to fasted conditions [see Dosage and Administration ( 2.1 )] .

Distribution The apparent mean ± SD volume of distribution of moxidectin is 2421 ± 1658 L in patients with onchocerciasis. The plasma protein binding in humans is 99.92%. Elimination The mean terminal half-life of moxidectin in patients with onchocerciasis is 23.3 days (559 hours) following a single 8 mg dose of Moxidectin Tablets.

The apparent mean ± SD total clearance of moxidectin is approximately 3.50 ±

1.23L/hour in patients with onchocerciasis. Metabolism The hepatic metabolism of moxidectin is minimal. Excretion Following administration of a single 8 mg oral dose of Moxidectin Tablets to healthy subjects, 2% of the dose is eliminated unchanged in the feces within the first 72 hours.

Renal elimination of intact drug is negligible. Specific Populations In clinical studies, no clinically significant differences in the pharmacokinetics of moxidectin were observed based on age (18 to 60 years), sex, weight (42.7 to 107.2 kg), or renal impairment (creatinine clearance (CrCL) 47 to 89 mL/min, estimated by Cockcroft-Gault). The pharmacokinetics of moxidectin in patients with CrCL less than 47 mL/min is unknown.

The pharmacokinetics of moxidectin in patients with hepatic impairment is unknown. Patients with Renal Impairment Based on a population pharmacokinetic analysis and negligible renal elimination of moxidectin, mild (creatinine clearance (CrCL), estimated by Cockcroft-Gault of 60 to 89 mL/min) and moderate (CrCL 30 to 59 mL/min) renal impairment is not likely to have an impact on the exposure of moxidectin. The effect of severe renal impairment (CrCL 15 to 29 mL/min) or of end-stage renal disease on the pharmacokinetics of moxidectin is unknown.

Pediatric Patients A pharmacokinetic study was conducted in 36 pediatric patients aged 4 to 17 years with unknown O. volvulus infection status who were administered a single dose of moxidectin (4, 6, or 8 mg). Body weight was identified as a key covariate in the population pharmacokinetic analysis. The simulated mean pharmacokinetic parameters of moxidectin following a single 4, 6, and 8 mg oral dose of Moxidectin Tablets in a U.S. pediatric population weighing 13 kg to less than 15 kg, 15 kg to less than 30 kg, and 30 kg and greater, respectively, are shown in Table 6.

Table 6: Mean (CV%) Pharmacokinetic Parameters for Moxidectin Following… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 18 words ▾

12.1Mechanism of Action Moxidectin, a macrocyclic lactone, is an anthelmintic drug [see Microbiology ( 12.4 )] .

📦 How Supplied / Storage and Handling 67 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Moxidectin Tablets containing 2 mg moxidectin are white to pale yellow uncoated oval-shaped tablets, debossed on one side with “AKKA”. Each high-density polyethylene bottle contains 500 tablets (NDC 71705-050-01), a silica gel desiccant and rayon coil. Store below 30°C (86°F). Protect from light. Once open, the full contents of the container should be used within 24 hours and discard any unused content.

📋 Description 146 words ▾

11 DESCRIPTION Moxidectin Tablets contain moxidectin, an anthelmintic drug and a macrocyclic lactone of the milbemycin class derived from the actinomycete Streptomyces cyanogriseus. The chemical name of moxidectin is (2aE,4E,5'R,6R,6'S,8E,11R,13S,15S,17aR,20R,20aR,20bS)-6'-[(E)-1,3-dimethyl-1-butenyl]-5',6,6',7,10,11,14,15,17a,20,20a,20b-dodecahydro-20,20b-dihydroxy-5',6,8,19-tetramethylspiro[11,15-methano-2H,13H,17H-furo[4,3,2-pq][2,6]benzodioxacyclooctadecin-13,2'-[2H]pyran]-4',17(3'H)-dione 4'-(E)-(O-methyloxime).

The structural formula is: Figure 1 : Moxidectin Structure Moxidectin is a white or pale-yellow, amorphous powder. The empirical formula is C 37 H 53 NO 8 and the molecular weight is 639.82 Dalton. Moxidectin is readily soluble in organic solvents such as methylene chloride, diethyl ether, ethanol, acetonitrile, and ethyl acetate.

It is only slightly soluble in water (0.51 mg/L) and the melting point range for moxidectin powder is 145°C to 154°C. Moxidectin Tablets are for oral administration. Each tablet contains 2 mg of moxidectin.

The tablets are uncoated and include the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. Figure 1: Moxidectin Structure

💬 Information for Patients 211 words ▾

17 PATIENT COUNSELING INFORMATION Signs and Symptoms Associated with Microfilarial Death Advise patients that they are likely to have flu like symptoms including malaise, myalgia, headache, tachycardia, hypotension and pruritus, most commonly during the first week after treatment. [see Warnings and Precautions ( 5.1 )] . Symptomatic Orthostatic Hypotension Advise patients that if they feel dizzy, faint or light-headed after taking Moxidectin Tablets, they should lie down until the symptoms resolve. [see Warnings and Precautions ( 5.2 )] .

Absence of Macrofilarial Activity Advise patients that treatment with Moxidectin Tablets does not kill adult O . volvulus and that follow up evaluation is usually required. Edema and Worsening of Onchodermatitis Advise patients with hyper-reactive onchodermatitis that they may be more likely to experience severe adverse reactions. [see Warnings and Precautions ( 5.4 )] . Encephalopathy in Loa loa Co-infected Patients Advise patients to report any symptoms of encephalopathy to their healthcare provider. [see Warnings and Precautions ( 5.3 )] .

Lactation Advise women that breastfeeding is not recommended at the time of treatment with Moxidectin Tablets and for 7 days after treatment. [see Use in Specific Populations ( 8.2 )] . Manufactured for: Medicines Development for Global Health, Melbourne, Victoria, Australia © 2025 Medicines Development for Global Health. All rights reserved.

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics The pharmacokinetic parameters of moxidectin following a single 8 mg oral dose of Moxidectin Tablets to healthy subjects and patients with onchocerciasis under fasted conditions are shown in Table 5. Mean moxidectin C max and AUC increased approximately proportionally to dose over a dose range of 2 to 36 mg (0.25 to 4.5 times the approved recommended dose) in healthy subjects under fasted conditions. Table 5: Mean (± SD) Pharmacokinetic Parameters of Moxidectin Following a Single 8 mg Oral Dose of Moxidectin Tablets to Healthy Subjects and Patients with Onchocerciasis Under Fasted Conditions PK Parameter Healthy Subjects (N = 27 ) Patients with Onchocerciasis (N = 3 1 ) C max (ng/mL) 58.9 ± 12.5 63.1 ±

20.0T max * (hours) 4 (2, 8) 4 (1, 4) AUC inf (ng•h/mL) 3387 ± 1328 2738 ± 1606 Half-life (hours) 784 ± 347 559 ± 525 C max = maximum plasma concentration; T max = time to reach C max ; AUC inf = area under the plasma concentration-time curve from time 0 to infinity; * Median (range) Absorption Effect of Food Moxidectin mean C max and AUC increased on average by 34% and 39%, respectively, when administered with a standard high fat meal (900 calories, with a nutritional distribution of approximately 55% fat, 31% carbohydrates and 14% protein), compared to fasted conditions [see Dosage and Administration ( 2.1 )] .

Distribution The apparent mean ± SD volume of distribution of moxidectin is 2421 ± 1658 L in patients with onchocerciasis. The plasma protein binding in humans is 99.92%. Elimination The mean terminal half-life of moxidectin in patients with onchocerciasis is 23.3 days (559 hours) following a single 8 mg dose of Moxidectin Tablets.

The apparent mean ± SD total clearance of moxidectin is approximately 3.50 ±

1.23L/hour in patients with onchocerciasis. Metabolism The hepatic metabolism of moxidectin is minimal. Excretion Following administration of a single 8 mg oral dose of Moxidectin Tablets to healthy subjects, 2% of the dose is eliminated unchanged in the feces within the first 72 hours.

Renal elimination of intact drug is negligible. Specific Populations In clinical studies, no clinically significant differences in the pharmacokinetics of moxidectin were observed based on age (18 to 60 years), sex, weight (42.7 to 107.2 kg), or renal impairment (creatinine clearance (CrCL) 47 to 89 mL/min, estimated by Cockcroft-Gault). The pharmacokinetics of moxidectin in patients with CrCL less than 47 mL/min is unknown.

The pharmacokinetics of moxidectin in patients with hepatic impairment is unknown. Patients with Renal Impairment Based on a population pharmacokinetic analysis and negligible renal elimination of moxidectin, mild (creatinine clearance (CrCL), estimated by Cockcroft-Gault of 60 to 89 mL/min) and moderate (CrCL 30 to 59 mL/min) renal impairment is not likely to have an impact on the exposure of moxidectin. The effect of severe renal impairment (CrCL 15 to 29 mL/min) or of end-stage renal disease on the pharmacokinetics of moxidectin is unknown.

Pediatric Patients A pharmacokinetic study was conducted in 36 pediatric patients aged 4 to 17 years with unknown O. volvulus infection status who were administered a single dose of moxidectin (4, 6, or 8 mg). Body weight was identified as a key covariate in the population pharmacokinetic analysis. The simulated mean pharmacokinetic parameters of moxidectin following a single 4, 6, and 8 mg oral dose of Moxidectin Tablets in a U.S. pediatric population weighing 13 kg to less than 15 kg, 15 kg to less than 30 kg, and 30 kg and greater, respectively, are shown in Table 6.

Table 6: Mean (CV%) Pharmacokinetic Parameters for Moxidectin Following a Single Oral Weight Based Dose of Moxidectin Tablets in Pediatric Patients PK Parameter Following 4 mg single dose in pediatric patients weighing 13 kg to less than 15 kg Following 6 mg single dose in pediatric patients weighing 15 kg to less than 30 kg Following 8 mg single dose in pediatric patients weighing 30… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 25 words ▾

12.2Pharmacodynamics Cardiac Electrophysiology At a dose 4.5 times the approved recommended dose, moxidectin does not prolong the QT interval to any clinically relevant extent.

🔬 Clinical Studies ~3 min read ▾

6.1Clinical Trials Experience Because clinical trials are conducted under varying controlled conditions, adverse reaction rates observed in one clinical trial cannot be directly compared to rates observed in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Clinical Trials Experience in Adults and Pediatric Patients (12 Years to Less than 18 Years of Age) The safety of Moxidectin Tablets was evaluated in two randomized, double-blind, active-controlled studies in patients with confirmed onchocerciasis (Trial 1 and Trial 2) [see Clinical Studies ( 14 )] .

In Trial 1, 978 patients (including 53 pediatric patients aged 12 to less than 18 years) received Moxidectin Tablets as a single oral dose of 8 mg and 494 patients received ivermectin (including 24 pediatric patients aged 12 to less than 18 years) as a single oral dose of approximately 150 mcg/kg. In Trial 2, 127 patients aged 18 years or older received Moxidectin Tablets as a single oral dose ranging from 2 mg (this is not an approved dose) to 8 mg (38 received the recommended 8 mg dose) and 45 patients aged 18 years or older received ivermectin as a single oral dose of approximately 150 mcg/kg.

Most Common Adverse Reactions No patients withdrew from either trial due to adverse reactions. Adverse Reactions reported in Trial 1 in > 10% of patients are summarized in Table 2. Most were related to physical, vital signs and laboratory changes associated with Mazzotti reaction [see Warnings and Precautions ( 5.1 )] .

Table 2: Adverse Reactions Occurring in > 10% of Moxidectin-treated Patients with Onchocerciasis in Trial 1 Adverse Reaction Moxidectin N = 978 n (%) Ivermectin N = 494 n (%) Eosinophilia 721 (74) 390 (79) Pruritus 640 (65) 268 (54) Musculoskeletal pain a 623 (64) 257 (52) Headache 566 (58) 267 (54) Lymphocytopenia* 470 (48) 215 (44) Tachycardia b 382 (39) 148(30) Orthostatic tachycardia c 333 (34) 130 (26) Non-orthostatic tachycardia d 179 (18) 57 (12) Rash e 358 (37) 103 (21) Abdominal pain f 305 (31) 173 (35) Hypotension g 289 (30) 125 (25) Orthostatic hypotension h 212 (22) 81 (16) Pyrexia/Chills 268 (27) 88 (18) Leukocytosis 240 (25) 125 (25) Influenza like illness 226 (23) 102 (21) Neutropenia** 197 (20) 112 (23) Cough 168 (17) 88 (18) Lymph node pain 129 (13) 28 (6) Dizziness 121 (12) 44 (9) Diarrhea/Gastroenteritis/Enteritis 144 (15) 84 (17) Hyponatremia 112 (12) 65 (13) Peripheral swelling 107 (11) 30 (6) a Includes “myalgia”, “arthralgia”, “musculoskeletal pain”, “pain” and “back pain” b Includes “orthostatic heart rate increased”, “postural orthostatic tachycardia syndrome”, “heart rate increased” and “sinus tachycardia” c Includes “orthostatic heart rate increased” and “postural orthostatic tachycardia syndrome” d Includes “heart rate increased”, “tachycardia”, and “sinus tachycardia” e Includes “rash,” “papular rash” and “urticaria” f Includes “abdominal pain”, “abdominal pain upper” and “abdominal pain lower” g Includes “orthostatic hypotension”, “blood pressure orthostatic decreased”, “blood pressure decreased”, “mean arterial pressure decreased”, “hypotension” h Includes “orthostatic hypotension”, and “blood pressure orthostatic decreased” *Lymphocytopenia is defined as absolute lymphocyte count less than 1 x 10 9 /L **Neutropenia is defined as absolute neutrophil count less than 1 x 10 9 /L The most common adverse reactions in patients (N = 38) treated with 8 mg moxidectin in Trial 2 were similar to the adverse reactions noted in Trial 1 described in Table 2above.

Other Adverse Reactions Reported in Clinical Trials (Trial 1 and Trial 2) The following adverse reactions occurred in less than 10% of subjects receiving Moxidectin Tablets in Trial 1: Ocular Adverse Reactions : In Trial 1, the most common ocular adverse reactions (occurring in ≥ 0.5% of patients) is shown in Table 3. Table 3: Ocular Adverse Reactions Occurring in ≥ 0.5% Moxidectin-treated Patients Adverse Reaction Moxidectin N = 978 n ( % ) Iver… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Two-year carcinogenicity studies in mice and rats were conducted with moxidectin. Mice were administered a mean dietary dose of 8.7 mg/kg/day moxidectin which is approximately equivalent to 5 times the recommended human dose based on body surface area comparison. Rats were administered a mean dietary dose of 6.1 mg/kg/day moxidectin which is approximately equivalent to 7 times the recommended human dose based on body surface area comparison.

There was no evidence of tumorigenicity in either study. Mutagenesis Moxidectin was shown to be negative for genotoxicity in a battery of in vitro assays including a bacterial mutagenicity assay, mouse lymphoma cell mutagenicity assay, unscheduled DNA synthesis assay, and a chromosome aberration assay, as well as in vivo in a micronucleus assay in mice and a chromosome aberration assay in rats. Impairment of Fertility In fertility evaluations, male and female mating and fertility indices were not inhibited by oral-dietary moxidectin doses of approximately 0.86 mg/kg/day which is approximately equivalent to the recommended human dose based on body surface area comparison.

13.2Animal Toxicology and/or Pharmacology Moxidectin was associated with transient CNS-related clinical signs. In rats, a single oral dose of 20 mg/kg (equivalent to approximately 24 times the recommended human dose based on body surface area comparison) moxidectin was associated with piloerection, reduced arousal and body tone, abnormal gait, slowed breathing, and impaired righting reflex. In adult dogs, repeated oral doses of 1.6 mg/kg/day moxidectin (equivalent to approximately 7 times the recommended human dose based on body surface area comparison) was associated with lacrimation, languid appearance, tremors, slight salivation, and slight ataxia.

Similar clinical signs that were largely resolved after 24 and 48 hours in juvenile (11-week-old) and adult (10-monthold) dogs, respectively, were observed after a single oral dose of 3 mg/kg moxidectin (respectively, approximately 34 and 50 times the maximum recommended human dose in patients with onchocerciasis based on plasma AUC comparison).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 175 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Two-year carcinogenicity studies in mice and rats were conducted with moxidectin. Mice were administered a mean dietary dose of 8.7 mg/kg/day moxidectin which is approximately equivalent to 5 times the recommended human dose based on body surface area comparison. Rats were administered a mean dietary dose of 6.1 mg/kg/day moxidectin which is approximately equivalent to 7 times the recommended human dose based on body surface area comparison.

There was no evidence of tumorigenicity in either study. Mutagenesis Moxidectin was shown to be negative for genotoxicity in a battery of in vitro assays including a bacterial mutagenicity assay, mouse lymphoma cell mutagenicity assay, unscheduled DNA synthesis assay, and a chromosome aberration assay, as well as in vivo in a micronucleus assay in mice and a chromosome aberration assay in rats. Impairment of Fertility In fertility evaluations, male and female mating and fertility indices were not inhibited by oral-dietary moxidectin doses of approximately 0.86 mg/kg/day which is approximately equivalent to the recommended human dose based on body surface area comparison.

📄 Recent Major Changes 16 words ▾

Indications and Usage ( 1 ) 2/2025 Dosage and Administration ( 2.1 , 2.2 ) 2/2025

📄 Package Label / Principal Display Panel 15 words ▾

PRINCIPAL DISPLAY PANEL NDC 71705-050-01 moxidectin tablets 2 mg 500 tablets Rx Only Moxidectin label

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

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) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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 Medicines Development for Global Health. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Medicines Development for Global Health 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.
← 71699-0204-14 · SK 71707-0011-01 · TULSA →
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.