21 CFR § 520.1445 - Milbemycin oxime and praziquantel.

---
identifier: "/us/cfr/t21/s520.1445"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.1445 - Milbemycin oxime and praziquantel."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.1445"
section_name: "Milbemycin oxime and praziquantel."
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"
---


# 520.1445 Milbemycin oxime and praziquantel.

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

(1) 2.3 milligrams (mg) milbemycin oxime and 22.8 mg praziquantel;

(2) 5.75 mg milbemycin oxime and 57 mg praziquantel;

(3) 11.5 mg milbemycin oxime and 114 mg praziquantel; or

(4) 23 mg milbemycin oxime and 228 mg praziquantel.

(b) *Sponsor.* See No. 058198 in § 510.600(c) of this chapter.

(c) *Conditions of use*—(1) *Dogs*—(i) *Amount.* Administer orally, once a month, a minimum dosage of 0.23 mg per pound (mg/lb) of body weight (0.5 mg per kilogram (mg/kg)) milbemycin oxime and 2.28 mg/lb of body weight (5 mg/kg) praziquantel.

(ii) *Indications for use.* For the prevention of heartworm disease caused by *Dirofilaria immitis* and for the treatment and control of adult roundworm (*Toxocara canis, Toxascaris leonina*), adult hookworm (*Ancylostoma caninum*), adult whipworm (*Trichuris vulpis*), and adult tapeworm (*Taenia pisiformis, Echinococcus multilocularis, E. granulosus,* and *Dipylidium caninum*) infections in dogs and puppies 2 pounds of body weight or greater and 6 weeks of age and older.

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

(2) [Reserved]

[77 FR 47512, Aug. 9, 2012, as amended at 82 FR 58556, Dec. 13, 2017]