21 CFR § 520.314 - Cefadroxil.

---
identifier: "/us/cfr/t21/s520.314"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.314 - Cefadroxil."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.314"
section_name: "Cefadroxil."
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: "520"
part_name: "ORAL 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 13838, Mar. 27, 1975, unless otherwise noted."
cfr_part: "520"
---


# 520.314 Cefadroxil.

(a) *Specifications.* (1) Each tablet contains 50, 100, or 200 milligrams (mg) or 1 gram of cefadroxil.

(2) Each milliliter of suspension constituted from powder contains 50 mg of cefadroxil.

(b) *Sponsor.* See No. 042791 in § 510.600(c) of this chapter.

(c) *Conditions of use in dogs and cats*—(1) *Amount*—(i) *Dogs.* Administer 10 mg per pound (/lb) body weight twice daily orally.

(ii) *Cats.* Administer 10 mg/lb body weight once daily orally.

(2) *Indications for use*—(i) *Dogs.* For the treatment of skin and soft tissue infections including cellulitis, pyoderma, dermatitis, wound infections, and abscesses due to susceptible strains of *Staphylococcus aureus.* For the treatment of genitourinary tract infections (cystitis) due to susceptible strains of *Escherichia coli*, *Proteus mirabilis*, and *S. aureus.*

(ii) *Cats.* For the treatment of skin and soft tissue infections including abscesses, wound infections, cellulitis, and dermatitis caused by susceptible strains of *Pasteurella multocida*, *S. aureus*, *Staphylococcus epidermidis*, and *Streptococcus* spp.

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

[75 FR 10165, Mar. 5, 2010, as amended at 87 FR 76421, Dec. 14, 2022]