21 CFR § 524.1001 - Fluralaner and moxidectin.

---
identifier: "/us/cfr/t21/s524.1001"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 524.1001 - Fluralaner and moxidectin."
title_number: 21
title_name: "Food and Drugs"
section_number: "524.1001"
section_name: "Fluralaner and moxidectin."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "524"
part_name: "OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13873, Mar. 27, 1975, unless otherwise noted."
cfr_part: "524"
---


# 524.1001 Fluralaner and moxidectin.

(a) *Specifications.* Each milliliter of solution contains 280 milligram (mg) fluralaner and 14 mg moxidectin. Each individually packaged tube contains either 112.5 mg fluralaner and 5.6 mg moxidectin; 250 mg fluralaner and 12.5 mg moxidectin; or 500 mg fluralaner and 25 mg moxidectin.

(b) *Sponsor.* See No. 000061 in § 510.600(c) of this chapter.

(c) *Conditions of use*—(1) *Amount.* Administer topically as a single dose every 2 months to provide a minimum dose of 18.2 mg/lb (40 mg/kg) fluralaner and 0.9 mg/lb (2 mg/kg) moxidectin.

(2) *Indications for use.* For the prevention of heartworm disease caused by *Dirofilaria immitis* and for the treatment of infections with intestinal roundworm (*Toxocara cati,* fourth-stage larvae, immature adults, and adults) and hookworm (*Ancylostoma tubaeforme,* fourth-stage larvae, immature adults, and adults); kills adult fleas and is indicated for the treatment and prevention of flea infestations (*Ctenocephalides felis*) and the treatment and control of tick infestations (*Ixodes scapularis* (black-legged tick), *Dermacentor variabilis* (American dog tick), and *Haemaphysalis longicornis* (Asian longhorned tick)) for 2 months in cats and kittens 6 months of age and older and weighing 2.6 lb or greater.

(3) *Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[85 FR 18120, Apr. 1, 2020, as amended at 87 FR 58963, Sept. 29, 2022; 88 FR 14901, Mar. 10, 2023]