21 CFR § 520.1615 - Omeprazole.

---
identifier: "/us/cfr/t21/s520.1615"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.1615 - Omeprazole."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.1615"
section_name: "Omeprazole."
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"
---


# 520.1615 Omeprazole.

(a) *Specifications.* Each gram of paste contains 0.37 gram omeprazole.

(b) *Sponsor.* See No. 000010 in § 510.600(c) of this chapter.

(c) *Special considerations.* When labeled for use as in paragraph (d)(2)(i) of this section, product labeling shall bear: “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”

(d) *Conditions of use in horses*—(1) *Amount.* (i) For treatment of gastric ulcers, 1.8 milligrams per pound (mg/lb) of body weight (4 milligrams per kilogram (mg/kg)) once daily for 4 weeks. For prevention of recurrence of gastric ulcers, 0.9 mg/lb of body weight (2 mg/kg) once daily for at least an additional 4 weeks.

(ii) For prevention of gastric ulcers using the premarked syringe, one dose per day for 8 or 28 days. Each dose delivers at least 1 mg/kg of body weight. Horses over 1,200 lb body weight should receive two doses per day.

(2) *Indications for use.* (i) For treatment and prevention of recurrence of gastric ulcers in horses and foals 4 weeks of age and older.

(ii) For prevention of gastric ulcers in horses.

(3) *Limitations.* Do not use in horses intended for human consumption.

[69 FR 13220, Mar. 22, 2004, as amended at 71 FR 59374, Oct. 10, 2006; 84 FR 39183, Aug. 9, 2019]