21 CFR 520.1248

§ 520.1248 Levothyroxine.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 520.1248, § 520.1248 Levothyroxine, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87203
Permanent ID: ys:prov:87203@1
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Full text

(a) Specifications. 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. (b) Sponsors. See Nos. 059051 and 061690 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. 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. (2) Indications for use. For replacement therapy for diminished thyroid function in dogs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.