Drug Information for Levothyroxine Sodium (Mylan Pharmaceuticals Inc.): DESCRIPTION

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  • Levothyroxine sodium tablets, USP contain synthetic crystalline L-3,3’,5,5’-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has a molecular formula of C15H10I4N NaO4* H2O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:

  • Inactive Ingredients

  • Levothyroxine sodium tablets, USP, for oral administration, are available containing 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg or 300 mcg of levothyroxine sodium, USP. In addition, each tablet contains the following inactive ingredients: butylated hydroxyanisole, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, povidone, sodium lauryl sulfate and sucrose. The following are the coloring additives by tablet strength:

    Strength (mcg)Color additive(s)
    25FD&C Yellow No. 6 Aluminum Lake
    50None
    75FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake
    88D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake
    100D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake
    112D&C Red No. 27 Aluminum Lake, D&C Red No. 30 Aluminum Lake
    125FD&C Blue No. 1 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake
    137FD&C Blue No. 2 Aluminum Lake
    150FD&C Blue No. 2 Aluminum Lake
    175D&C Red No. 27 Aluminum Lake, D&C Red No. 30 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake
    200FD&C Red No. 40 Aluminum Lake
    300D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake
  • Drug Information Provided by National Library of Medicine (NLM).
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