---
kind: "section"
citation: "21 C.F.R. § 529.443"
title: "21"
number: "529.443"
heading: "Ciclesonide."
url: "https://uscodex.org/cfr/21/529.443"
---

# §529.443. Ciclesonide.

- (a) **Specifications.** A non-pressurized metered dose inhaler and drug cartridge combination containing a solution of 30 milligrams/milliliter of the prodrug ciclesonide. Each actuation releases 343 micrograms (mcg) of ciclesonide.
- (b) **Sponsor.** See No. 000010 in [§ 510.600(c)](/cfr/21/510.600.md?p=c) of this chapter.
- (c) **Conditions of use—**
  - (1) **Amount.** Administer an initial dose of 8 actuations (2,744 mcg ciclesonide) twice daily for 5 days, followed by 12 actuations (4,116 mcg ciclesonide) once daily for 5 days.
  - (2) **Indications for use.** For the management of clinical signs associated with severe equine asthma.
  - (3) **Limitations.** Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

## Notes

### Amendments

[86 FR 13188, Mar. 8, 2021]

### Authority

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

### Source

Source: 40 FR 13881, Mar. 27, 1975, unless otherwise noted.

### Amendments

[86 FR 13188, Mar. 8, 2021]