SYNTHROID Tablet Ref.[10711] Active ingredients: Levothyroxine

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

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:

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 6 provides a listing of the color additives by tablet strength:

Table 6. SYNTHROID Tablets Color Additives:

Strength (mcg) Color additive(s)
25 FD&C Yellow No. 6 Aluminum Lakea
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 Lakea, D&C Yellow No. 10 Aluminum Lake
100 D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lakea
112 D&C Red No. 27 & 30 Aluminum Lake
125 FD&C Yellow No. 6 Aluminum Lakea, 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 Lakea, FD&C Blue No. 1 Aluminum Lake

a Note – FD&C Yellow No. 6 is orange in color

Dosage Forms and Strengths

SYNTHROID tablets are available as follows:

Tablet Strength Tablet Color/Shape Tablet Markings
25 mcg Orange/Round “SYNTHROID” and “25”
50 mcg White/Round “SYNTHROID” and “50”
75 mcg Violet/Round “SYNTHROID” and “75”
88 mcg Olive/Round “SYNTHROID” and “88”
100 mcg Yellow/Round “SYNTHROID” and “100”
112 mcg Rose/Round “SYNTHROID” and “112”
125 mcg Brown/Round “SYNTHROID” and “125”
137 mcg Turquoise/Round “SYNTHROID” and “137”
150 mcg Blue/Round “SYNTHROID” and “150”
175 mcg Lilac/Round “SYNTHROID” and “175”
200 mcg Pink/Round “SYNTHROID” and “200”
300 mcg Green/Round “SYNTHROID” and “300”
How Supplied

SYNTHROID (levothyroxine sodium, USP) tablets are supplied as follows:

Strength
(mcg) 		Color/Shape Tablet
Markings 		NDC# for
bottles of 90 		NDC # for
bottles of 1000 		NDC # for
unit dose
cartons of 100
25 Orange/Round "SYNTHROID"
and “25” 		0074-4341-90 0074-4341-19 --
50 White/Round "SYNTHROID"
and “50” 		0074-4552-90 0074-4552-19 0074-4552-11
75 Violet/Round "SYNTHROID"
and “75” 		0074-5182-90 0074-5182-19 0074-5182-11
88 Olive/Round "SYNTHROID"
and “88” 		0074-6594-90 0074-6594-19 --
100 Yellow/Round "SYNTHROID"
and “100” 		0074-6624-90 0074-6624-19 0074-6624-11
112 Rose/Round "SYNTHROID"
and “112” 		0074-9296-90 0074-9296-19 --
125 Brown/Round "SYNTHROID"
and “125” 		0074-7068-90 0074-7068-19 0074-7068-11
137 Turquoise/Round "SYNTHROID"
and “137” 		0074-3727-90 0074-3727-19 --
150 Blue/Round "SYNTHROID"
and “150” 		0074-7069-90 0074-7069-19 0074-7069-11
175 Lilac/Round "SYNTHROID"
and “175” 		0074-7070-90 0074-7070-19 --
200 Pink/Round "SYNTHROID"
and “200” 		0074-7148-90 0074-7148-19 0074-7148-11
300 Green/Round "SYNTHROID"
and “300” 		0074-7149-90 0074-7149-19 --

AbbVie Inc., North Chicago, IL 60064, U.S.A.

Drugs

Drug Countries
SYNTHROID Brazil, Canada, Ecuador, Israel, Mexico, New Zealand, United States, South Africa
 
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