21 CFR § 520.1200 - Ivermectin, fenbendazole, and praziquantel tablets.

---
identifier: "/us/cfr/t21/s520.1200"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.1200 - Ivermectin, fenbendazole, and praziquantel tablets."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.1200"
section_name: "Ivermectin, fenbendazole, and praziquantel tablets."
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: "520"
part_name: "ORAL 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 13838, Mar. 27, 1975, unless otherwise noted."
cfr_part: "520"
---


# 520.1200 Ivermectin, fenbendazole, and praziquantel tablets.

(a) *Specifications.* Each chewable tablet contains either:

(1) 68 micrograms (µg) ivermectin, 1.134 grams fenbendazole, and 57 milligrams (mg) praziquantel; or

(2) 27 µg ivermectin, 454 mg fenbendazole, and 23 mg praziquantel.

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

(c) *Conditions of use in dogs*—(1) *Amount.* Administer tablets to provide 6 µg per kilogram (/kg) ivermectin, 100 mg/kg fenbendazole, and 5 mg/kg praziquantel.

(2) *Indications for use.* For the treatment and control of adult *Toxocara canis* (roundworm), *Ancylostoma caninum* (hookworm), *Trichuris vulpis* (whipworm), and *Dipylidium caninum* (tapeworm), and for the prevention of heartworm disease caused by *Dirofilaria immitis* in adult dogs.

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

[73 FR 33692, June 13, 2008, as amended at 74 FR 61516, Nov. 25, 2009]