---
kind: "section"
citation: "21 C.F.R. § 524.1001"
title: "21"
number: "524.1001"
heading: "Fluralaner and moxidectin."
url: "https://uscodex.org/cfr/21/524.1001"
---

# §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)](/cfr/21/510.600.md?p=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), Haemaphysalis longicornis (Asian longhorned tick), and Amblyomma maculatum (Gulf Coast 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.

## Notes

### Amendments

[85 FR 18120, Apr. 1, 2020, as amended at 87 FR 58963, Sept. 29, 2022; 88 FR 14901, Mar. 10, 2023; 91 FR 41560, July 7, 2026]

### Authority

Authority: 21 U.S.C. 360b.

### Source

Source: 40 FR 13873, Mar. 27, 1975, unless otherwise noted.

### Amendments

[85 FR 18120, Apr. 1, 2020, as amended at 87 FR 58963, Sept. 29, 2022; 88 FR 14901, Mar. 10, 2023; 91 FR 41560, July 7, 2026]