21 CFR § 520.2138 - Spironolactone and benazepril.

---
identifier: "/us/cfr/t21/s520.2138"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.2138 - Spironolactone and benazepril."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.2138"
section_name: "Spironolactone and benazepril."
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"
---


# 520.2138 Spironolactone and benazepril.

(a) *Specifications.* Each chewable tablet contains 20 milligrams (mg) spironolactone and 2.5 mg benazepril hydrochloride, 40 mg spironolactone and 5 mg benazepril hydrochloride, or 80 mg spironolactone and 10 mg benazepril hydrochloride.

(b) *Sponsor.* See No. 013744 in § 510.600(c) of this chapter.

(c) *Conditions of use in dogs*—(1) *Amount.* Administer orally once daily, with food, at a dose of 0.9 mg per pound (lb) (2 mg per kilogram (kg)) spironolactone and 0.11 mg/lb (0.25 mg/kg) benazepril hydrochloride, according to dog body weight using a suitable combination of whole and/or half tablets.

(2) *Indications for use.* With concurrent therapy (*e.g.,* furosemide, etc.) for the management of clinical signs of mild, moderate, or severe congestive heart failure in dogs due to atrioventricular valvular insufficiency (AVVI).

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

[86 FR 14819, Mar. 19, 2021]