21 CFR § 522.147 - Atipamezole.

---
identifier: "/us/cfr/t21/s522.147"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 522.147 - Atipamezole."
title_number: 21
title_name: "Food and Drugs"
section_number: "522.147"
section_name: "Atipamezole."
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: "522"
part_name: "IMPLANTATION OR INJECTABLE 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 13858, Mar. 27, 1975, unless otherwise noted."
cfr_part: "522"
---


# 522.147 Atipamezole.

(a) *Specifications.* Each milliliter of solution contains 5.0 milligrams atipamezole hydrochloride.

(b) *Sponsors.* See Nos. 015914, 052483, 068504, and 069043 in § 510.600(c) of this chapter.

(c) *Conditions of use in dogs*—(1) *Amount.* Administer 3,750 mcg/m
<sup>2</sup> intramuscularly for the reversal of intravenous dexmedetomidine hydrochloride or medetomidine hydrochloride and 5,000 mcg/m
<sup>2</sup> intramuscularly for the reversal of intramuscular dexmedetomidine hydrochloride or medetomidine hydrochloride.

(2) *Indications for use.* For the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride and medetomidine hydrochloride.

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

[61 FR 48830, Sept. 17, 1996, as amended at 64 FR 71640, Dec. 22, 1999; 72 FR 264, Jan. 4, 2007; 84 FR 8973, Mar. 13, 2019; 88 FR 84700, Dec. 6, 2023; 89 FR 42357, May 15, 2024]