---
kind: "section"
citation: "21 C.F.R. § 520.812"
title: "21"
number: "520.812"
heading: "Enrofloxacin."
url: "https://uscodex.org/cfr/21/520.812"
---

# §520.812. Enrofloxacin.

- (a) **Specifications.**
  - (1) **Each tablet contains—**
    - (i) 22.7, 68.0, or 136.0 milligrams (mg) enrofloxacin; or
    - (ii) 22.7, 68.0, 136.0, or 272 mg enrofloxacin.
  - (2) Each chewable tablet contains 22.7, 68.0, or 136.0 mg enrofloxacin.
  - (3) Each soft chewable tablet contains 22.7, 68.0, or 136.0 mg enrofloxacin.
- (b) **Sponsors.** See sponsor numbers in [§ 510.600(c)](/cfr/21/510.600.md?p=c) of this chapter for use as in [paragraph (c)](#c) of this section.
  - (1) **No.** 058198 for use of products described in [paragraph (a)](#a) of this section.
  - (2) **Nos.** 017033, 086117, and 086194 for use of product described in [paragraph (a)(1)(i)](#a-1-i) of this section.
  - (3) **Nos.** 055529 and 086101 for use of product described in [paragraph (a)(2)](#a-2) of this section.
- (c) **Conditions of use in dogs and cats—**
  - (1) **Amount.** Administer orally as a single, daily dose or divided into two equal doses at 12-hour intervals.
    - (i) **Dogs.** 5 to 20 mg per kilogram (/kg) (2.27 to 9.07 mg per pound (/lb)) of body weight.
    - (ii) **Cats.** 5 mg/kg (2.27 mg/lb) of body weight.
  - (2) **Indications for use.** For the management of diseases associated with bacteria susceptible to enrofloxacin.
  - (3) **Limitations.** Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals.

## Notes

### Amendments

[78 FR 30197, May 22, 2013, as amended at 78 FR 52853, Aug. 27, 2013; 84 FR 8972, Mar. 13, 2019; 84 FR 53310, Oct. 7, 2019; 86 FR 13184, Mar. 8, 2021; 87 FR 58961, Sept. 29, 2022; 88 FR 27698, May 3, 2023; 90 FR 40969, Aug. 22, 2025]

### Authority

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

### Source

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

### Amendments

[78 FR 30197, May 22, 2013, as amended at 78 FR 52853, Aug. 27, 2013; 84 FR 8972, Mar. 13, 2019; 84 FR 53310, Oct. 7, 2019; 86 FR 13184, Mar. 8, 2021; 87 FR 58961, Sept. 29, 2022; 88 FR 27698, May 3, 2023; 90 FR 40969, Aug. 22, 2025]