FDA label
What is Levoxyl used for?
Levoxyl contains levothyroxine. The FDA-approved uses below are 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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Levoxyl, tablet
Indications and Usage, quoted from the label by Pfizer Laboratories Div Pfizer Inc (NDA021301). Cross-references to other label sections are left out.
Hypothyroidism
LEVOXYL is indicated in pediatric and adult patients as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.
Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression
LEVOXYL is indicated in pediatric and adult patients as an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer.
Limitations of Use:
- LEVOXYL is 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 LEVOXYL may induce hyperthyroidism.
- LEVOXYL is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.
Source: DailyMed label, set id 758588c3-c63e-491b-0aa2-4f50d80cb174, version 12, effective December 15, 2020. NDC 60793-850, one of 11 listings for this product.
Questions
What is Levoxyl used for?
The FDA label says: “Hypothyroidism”
What drug class is Levoxyl?
FDA lists levothyroxine in the l-Thyroxine established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
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