21 CFR § 520.1150 - Imepitoin.

---
identifier: "/us/cfr/t21/s520.1150"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.1150 - Imepitoin."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.1150"
section_name: "Imepitoin."
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"
---


# 520.1150 Imepitoin.

(a) *Specifications.* Each tablet contains 100 or 400 milligrams (mg) imepitoin.

(b) *Sponsor.* See No. 000010 in § 510.600(c) of this chapter.

(c) *Conditions of use*—(1) *Amount.* Administer orally twice daily, approximately 12 hours apart, at a dose of 13.6 mg per pound (30 mg/kg) of body weight. Initiate therapy starting 2 days prior to the day of the expected noise event and continuing through the noise event.

(2) *Indications for use.* For the treatment of noise aversion in dogs.

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

[84 FR 12494, Apr. 2, 2019]