21 CFR 520.1200
§ 520.1200 Ivermectin, fenbendazole, and praziquantel tablets.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 520.1200, § 520.1200 Ivermectin, fenbendazole, and praziquantel tablets, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87193
- Permanent ID
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.