21 CFR § 520.1248Chapter I

§ 520.1248 Levothyroxine.

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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.

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Specifications.(a) Each tablet contains 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, or 1.0 milligrams (mg) levothyroxine sodium.

Sponsors.(b) See Nos. 059051 and 061690 in § 510.600(c) of this chapter.

Conditions of useAmount.(c) —(1) Administer by mouth as follows:

(i) No. 061690: 0.1 mg/10 pounds (lb) body weight (0.022 mg/kilogram (kg)) as a single dose every 24 hours or as a divided dose every 12 hours.

(ii) No. 059051: 0.1 mg/10 lb (0.01 mg/lb, 0.022 mg/kg) body weight twice daily.

Indications for use.(2) For replacement therapy for diminished thyroid function in dogs.

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

[81 FR 22523, Apr. 18, 2016, as amended at 86 FR 57996, Oct. 20, 2021]

eCFR data current as of: June 10, 2026

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