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21 CFR § 520.1315 - Maropitant.

---
identifier: "/us/cfr/t21/s520.1315"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.1315 - Maropitant."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.1315"
section_name: "Maropitant."
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"
---

# 520.1315 Maropitant.

(a) *Specifications.* Each tablet contains 16, 24, 60, or 160 milligrams (mg) maropitant as maropitant citrate.

(b) *Sponsors.* See Nos. 054771, 086101, and 086117 in § 510.600(c) of this chapter.

(c) *Conditions of use in dogs*—(1) *Indications for use and amount.* (i) For prevention of acute vomiting in dogs 2 to 7 months of age, administer a minimum dose of 2.0 mg per kilogram (/kg) body weight once daily for up to 5 consecutive days.

(ii) For prevention of acute vomiting in dogs 7 months of age and older, administer a minimum dose of 2.0 mg/kg body weight once daily until resolution of acute vomiting.

(iii) For prevention of vomiting due to motion sickness in dogs 4 months of age and older, administer a minimum of 8.0 mg/kg body weight once daily for up to 2 consecutive days.

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

[72 FR 9243, Mar. 1, 2007, as amended at 78 FR 28823, May 20, 2014; 80 FR 53459, Sept. 4, 2015; 88 FR 27699, May 3, 2023; 89 FR 85426, Oct. 28, 2024]