FDA label
What is Unithroid used for?
Unithroid 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”
Run it in Rivvi
Which 2027 plans near you dropped or restricted Unithroid?
Tier changes and new prior auth, step therapy or quantity limits, plan by plan.
Free to start. Opens Rivvi, the AI workspace for healthcare teams.
Unithroid, tablet
Indications and Usage, quoted from the label by Amneal Pharmaceuticals LLC (NDA021210). Cross-references to other label sections are left out.
Hypothyroidism
UNITHROID 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
UNITHROID is indicated in pediatric and adult patients as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
Limitations of Use:
- UNITHROID 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 UNITHROID may induce hyperthyroidism.
- UNITHROID is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.
Source: DailyMed label, set id 07562e72-7eaa-4ce6-94f0-e08814787e50, version 13, effective June 19, 2019. NDC 60846-801, one of 12 listings for this product.
Questions
What is Unithroid used for?
The FDA label says: “Hypothyroidism”
What drug class is Unithroid?
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.
More on Unithroid
- Is Unithroid a controlled substance?Federal schedule
- Generic for UnithroidFDA Orange Book
- What is Levothyroxine used for?FDA label uses
- Is Levothyroxine a controlled substance?Federal schedule
- Generic for TirosintFDA Orange Book
- Generic for ThyquidityFDA Orange Book
- Generic for Tirosint-solFDA Orange Book
- Generic for Levo-tFDA Orange Book
- Generic for LevoletFDA Orange Book
- Generic for LevoxylFDA Orange Book
- Generic for SynthroidFDA Orange Book
- Generic for Thyro-tabsFDA Orange Book
- L-Thyroxines listFDA drug class
- Unithroid Medicare Part D coverageBy plan and state
- NDC 60846-801Unithroid NDC record
- NDC 60846-802Unithroid NDC record