Application Nr Approved Date Route Status External Links
NDA021210 2008-02-08 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Levothyroxine Sodium Is Used For The Following Indications: Hypothyroidism - As Replacement Or Supplemental Therapy In Congenital Or Acquired Hypothyroidism Of Any Etiology, Except Transient Hypothyroidism During The Recovery Phase Of Subacute Thyroiditis. Specific Indications Include: Primary (thyroidal), Secondary (pituitary), And Tertiary (hypothalamic) Hypothyroidism And Subclinical Hypothyroidism. Primary Hypothyroidism May Result From Functional Deficiency, Primary Atrophy, Partial Or Total Congenital Absence Of The Thyroid Gland, Or From The Effects Of Surgery, Radiation, Or Drugs, With Or Without The Presence Of Goiter. Pituitary Tsh Suppression - In The Treatment Or Prevention Of Various Types Of Euthyroid Goiters (see Warnings And Precautions ), Including Thyroid Nodules (see Warnings And Precautions ), Subacute Or Chronic Iymphocytic Thyroiditis (hashimoto's Thyroiditis), Multinodular Goiter (see Warnings And Precautions ), And, As An Adjunct To Surgery And Radioiodine Therapy In The Management Of Thyrotropin-Dependent Well-Differentiated Thyroid Cancer.

All Formulated Excipients (5 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Lactose, Unspecified Form LACTOSE, UNSPECIFIED FORM Molecular
3. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
4. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
5. Starch, Corn STARCH, CORN Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Levothyroxine Sodium LEVOTHYROXINE SODIUM ZINC3830993