Prescription medicine
Moxidectin
Moxidectin is a prescription medicine with an FDA approval on record since 2018. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the moxidectin FDA label on DailyMed (effective July 30, 2026, Medicines Development for Global Health); the NDA 210867 record on Drugs@FDA; every moxidectin label on DailyMed.
Highlights of the record
FDA label of July 30, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageMoxidectin 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 )].
Forms and strengths
- 2 mg
Tablet.
On the market
- Earliest approval on file
- June 13, 2018 Moxidectin, Mdgh; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 3 through July 30, 2026
What is moxidectin used for?
From the label: indications and usageMoxidectin 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. […]
Source: FDA drug label (Moxidectin), NDA210867 (Mdgh), as published by Medicines Development for Global Health, effective July 30, 2026 (SPL set 6eb02ae9-9065-176f-e053-2991aa0ac891), via openFDA; the full label on DailyMed
Is there a generic for moxidectin?
No generic moxidectin is approved (Drugs@FDA, October 8, 2026).
- 2018 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the moxidectin label say about other medicines?
The moxidectin label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Ivermectin | warnings and precautions | 47/978 (5%) compared with 8/494 (2%) who received ivermectin. |
| Midazolam | drug interactions | DRUG INTERACTIONS 7.1 Midazolam (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 ) ]. |
Source: FDA drug label (Moxidectin), NDA210867 (Mdgh), as published by Medicines Development for Global Health, effective July 30, 2026 (SPL set 6eb02ae9-9065-176f-e053-2991aa0ac891), via openFDA; the full label on DailyMed
What do FAERS reports show for moxidectin?
The FDA Adverse Event Reporting System holds 3 reports that list moxidectin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 1 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Moxidectin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other