LEVOXYL Tablet Ref.[10582] Active ingredients: Levothyroxine

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

Product 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:

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

Dosage Forms and Strengths

LEVOXYL tablets are oval, color-coded and, potency marked available as follows:

Strength (mcg)	Color	Tablet Markings
25	Orange	25
50	White	50
75	Purple	75
88	Olive	88
100	Yellow	100
112	Rose	112
125	Light Brown	125
137	Dark Blue	137
150	Blue	150
175	Turquoise	175
200	Pink	200

How Supplied

LEVOXYL (levothyroxine sodium) tablets are oval, color-coded and, potency marked available as follows:

Strength (mcg)	Color	Tablet Markings	NDC - bottles of 100	NDC - bottles of 1000
25	Orange	25	60793-850-01	60793-850-10
50	White	50	60793-851-01	60793-851-10
75	Purple	75	60793-852-01	60793-852-10
88	Olive	88	60793-853-01	60793-853-10
100	Yellow	100	60793-854-01	60793-854-10
112	Rose	112	60793-855-01	60793-855-10
125	Light Brown	125	60793-856-01	60793-856-10
137	Dark Blue	137	60793-857-01	60793-857-10
150	Blue	150	60793-858-01	60793-858-10
175	Turquoise	175	60793-859-01	60793-859-10
200	Pink	200	60793-860-01	60793-860-10

Drugs

Drug	Countries
LEVOXYL	United States

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