21 CFR § 520.812Chapter I

§ 520.812 Enrofloxacin.

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Verbatim text below is from the Electronic Code of Federal Regulations (eCFR), a public-domain U.S. government work. Always verify the current version with the eCFR before relying on it for any legal matter.

Full Text

Specifications.(a) (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.

Sponsors.(b) See sponsor numbers in § 510.600(c) of this chapter for use as in paragraph (c) of this section.

(1) No. 058198 for use of products described in paragraph (a) of this section.

(2) Nos. 017033, 086117, and 086194 for use of product described in paragraph (a)(1)(i) of this section.

(3) Nos. 055529 and 086101 for use of product described in paragraph (a)(2) of this section.

Conditions of use in dogs and catsAmount.(c) —(1) Administer orally as a single, daily dose or divided into two equal doses at 12-hour intervals.

Dogs.(i) 5 to 20 mg per kilogram (/kg) (2.27 to 9.07 mg per pound (/lb)) of body weight.

Cats.(ii) 5 mg/kg (2.27 mg/lb) of body weight.

Indications for use.(2) For the management of diseases associated with bacteria susceptible to enrofloxacin.

Limitations.(3) 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.

[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]

eCFR data current as of: June 10, 2026

This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.