SPL Set ID: 1e11ad30-1041-4520-10b0-8f9d30d30fcc
1 drug(s) with this SPL Set ID
SYNTHROID (levothyroxine sodium tablets, USP) is L-thyroxine (T4) and contains synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15 H 10 I 4 N NaO 4 • H 2 O, molecular weight of 798.86 (anhydrous), and structural formula as shown: SYNTHROID 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, 200 mcg, and 300 mcg. Each SYNTHROID tablet contains the inactive ingredients acacia, confectioner's sugar (contains corn starch), lactose monohydrate, magnesium stearate, povidone, and talc. SYNTHROID tablets contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Each tablet strength meets USP Dissolution Test 3. Table 9 provides a listing of the color additives by tablet strength: Table 9: SYNTHROID Tablet Color Additives Strength (mcg) Color additive(s) 25 FD&C Yellow No. 6 Aluminum Lake* 50 None 75 FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake 88 FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake*, D&C Yellow No. 10 Aluminum Lake 100 D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake* 112 D&C Red No. 27 & 30 Aluminum Lake 125 FD&C Yellow No. 6 Aluminum Lake*, FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake 137 FD&C Blue No. 1 Aluminum Lake 150 FD&C Blue No. 2 Aluminum Lake 175 FD&C Blue No. 1 Aluminum Lake, D&C Red No. 27 & 30 Aluminum Lake 200 FD&C Red No. 40 Aluminum Lake 300 D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake*, FD&C Blue No. 1 Aluminum Lake * Note – FD&C Yellow No. 6 is orange in color. SYNTHROID (levothyroxine sodium tablets, USP) contain synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4N NaO4• H2O, molecular weight of 798.86 (anhydrous), and structural formula as shown: