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Prescription medicine

Moxidectin

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

Quick answers

What is Moxidectin used for?
The FDA-approved label (Moxidectin, Medicines Development for Global Health, July 30, 2026) says: “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 […]. 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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Moxidectin have a boxed warning?
No. None of the 1 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Moxidectin?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Moxidectin been recalled?
No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
Who makes Moxidectin?
1 company lists prescription products of Moxidectin in the FDA NDC Directory, including Medicines Development for Global Health.

What Moxidectin is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

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 […]. 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. …

— FDA label: Moxidectin, Medicines Development for Global Health, effective July 30, 2026. Read the full label on DailyMed →

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

Forms and how it is given

Dosage formsTablet
RouteOral
Prescription products1 in the FDA NDC Directory

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA210867
MOXIDECTIN
MdghJune 13, 2018 3, latest February 7, 2025
2025: Efficacy · 2021: Labeling · 2019: Labeling

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

RxCUI (RxNorm)2049015
SPL set ID of the quoted label6eb02ae9-9065-176f-e053-2991aa0ac891
FDA labels (SPL)1
FDA applicationsNDA210867
Active ingredients (FDA)MOXIDECTIN

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Moxidectin, Medicines Development for Global Health, effective July 30, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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