Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 520.1315: Maropitant.

(a) Specifications. (1) Each tablet contains 16, 24, 60, or 160 milligrams (mg) maropitant as maropitant citrate.
(2) Each chewable tablet contains 16, 24, 60, or 160 mg maropitant as maropitant citrate.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter:
(1) Nos. 054771, 086101, and 086117 for use of the product described in paragraph (a)(1) of this section as in paragraph (c) of this section.
(2) No. 086101 for use of the product described in paragraph (a)(2) of this section as in paragraph (c) of this section.
(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.

Where this section sits in the code

Title 21—Food and Drugs
CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

(a) Specifications. (1) Each tablet contains 16, 24, 60, or 160 milligrams (mg) maropitant as maropitant citrate.

(2) Each chewable tablet contains 16, 24, 60, or 160 mg maropitant as maropitant citrate.

(b) Sponsors. See sponsors in § 510.600(c) of this chapter:

(1) Nos. 054771, 086101, and 086117 for use of the product described in paragraph (a)(1) of this section as in paragraph (c) of this section.

(2) No. 086101 for use of the product described in paragraph (a)(2) of this section as in paragraph (c) of this section.

(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.

Collected 2026-08-27T02:24:47Z. Source file · JSON

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