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 Lake^a
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^a, D&C Yellow No. 10 Aluminum Lake
100		D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake^a
112		D&C Red No. 27 & 30 Aluminum Lake
125		FD&C Yellow No. 6 Aluminum Lake^a, 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^a, 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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