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LEVOXYL® (levothyroxine sodium) Description

11 DESCRIPTION

LEVOXYL contains the active ingredient, levothyroxine, asynthetic crystalline levothyroxine (T4) in sodium salt form. It is chemically designated as L-3,3',5,5'-tetraiodothyronine monosodium hydrate. Synthetic T4 is identical in chemical structure to the T4 produced in the human thyroid gland. Levothyroxine sodium has an empirical formula of C15H10I4N NaO4 ∙ H2O, molecular weight of 798.85 g/mol (anhydrous), and structural formula as shown:

Chemical Structure

LEVOXYL tablets for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, and 200 mcg.

Inactive Ingredients

Calcium sulfate dihydrate, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and sodium bicarbonate. The following are the coloring additives per tablet strength:

Strength
(mcg)
Color additive(s)
25 FD&C Yellow No. 6 Aluminum Lake
50 None
75 FD&C Blue No. 1 Aluminum Lake, D&C Red No. 30 Aluminum Lake
88 FD&C Yellow No. 6 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake
100 FD&C Yellow No. 6 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake
112 FD&C Yellow No. 6 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, D&C Red No. 30 Aluminum Lake
125 FD&C Red No. 40 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake
137 FD&C Blue No. 1 Aluminum Lake
150 FD&C Blue No. 1 Aluminum Lake, D&C Red No. 30 Aluminum Lake
175 FD&C Blue No. 1 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake
200 D&C Red No. 30 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake

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