FDA label

What is levothyroxine used for?

The FDA-approved uses of levothyroxine, quoted from the Indications and Usage section of its DailyMed label.

Source: DailyMed SPL label file dated 2026-10-23. Publisher page

The FDA label says: “Hypothyroidism”

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Levothyroxine Sodium, tablet

Indications and Usage, quoted from the label by Accord Healthcare Inc. (ANDA212399). Cross-references to other label sections are left out.

Hypothyroidism
Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.
Pituitary Thyrotropin (Thyroid‑Stimulating Hormone, TSH) Suppression
Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
Limitations of Use
Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium may induce hyperthyroidism.
Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.

Source: DailyMed label, set id a6233381-3043-4e9a-aaa6-a6b105e5142b, version 11, effective October 17, 2025. NDC 16729-447, one of 315 listings for this product.

Levothyroxine Sodium Anhydrous, injection, powder, lyophilized, for solution

Indications and Usage, quoted from the label by MAIA Pharmaceuticals, Inc. (ANDA208749). Cross-references to other label sections are left out.

Levothyroxine Sodium for Injection is indicated for the treatment of myxedema coma. Important Limitations of Use: The relative bioavailability between

Source: DailyMed label, set id 4e9adc35-3aba-4a0d-9c4e-7e7ee2ffdabd, version 5, effective August 5, 2026. NDC 70511-111, one of 14 listings for this product.