---
kind: "section"
citation: "21 C.F.R. § 520.1315"
title: "21"
number: "520.1315"
heading: "Maropitant."
url: "https://uscodex.org/cfr/21/520.1315"
---

# §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)](/cfr/21/510.600.md?p=c) of this chapter:
  - (1) **Nos.** 054771, 086101, and 086117 for use of the product described in [paragraph (a)(1)](#a-1) of this section as in [paragraph (c)](#c) of this section.
  - (2) **No.** 086101 for use of the product described in [paragraph (a)(2)](#a-2) of this section as in [paragraph (c)](#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.

## Notes

### Amendments

[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; 91 FR 41559, July 7, 2026]

### Authority

Authority: 21 U.S.C. 360b.

### Source

Source: 40 FR 13838, Mar. 27, 1975, unless otherwise noted.

### Amendments

[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; 91 FR 41559, July 7, 2026]