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Levothyroxine Sodium 0.1 mg

1 INDICATIONS AND USAGE Hypothyroidism: Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer . Limitations of Use: • Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.1) ]. • Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. Levothyroxine sodium tablets are a L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: • Hypothyroidism: As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. ( 1 ) • Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. ( 1 ) Limitations of Use: • not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients • Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis

Mylan Pharmaceuticals Inc.


7 years ago OVAL YELLOW M L 8 Levothyroxine Sodium 0.1 mg

OVAL YELLOW M L 8

7 years ago OVAL YELLOW M L 8 Levothyroxine Sodium 0.1 mg

M L 8 OVAL YELLOW

16 HOW SUPPLIED/STORAGE AND HANDLING

LEVOTHYROXINE SODIUM Tablets, USP are available containing 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg or 300 mcg of

LEVOTHYROXINE SODIUM, USP. They are available as follows: The 25 mcg tablets are orange, capsule-shaped, scored tablets debossed with L to the left of the score and 4 to the right of the score on one side of the tablet and M on the other side. NDC 0378-1800-77 bottles of 90 tablets NDC 0378-1800-10 bottles of 1000 tablets The 50 mcg tablets are white, capsule-shaped, scored tablets debossed with L to the left of the score and 5 to the right of the score on one side of the tablet and M on the other side. NDC 0378-1803-77 bottles of 90 tablets NDC 0378-1803-10 bottles of 1000 tablets The 75 mcg tablets are violet, capsule-shaped, scored tablets debossed with L to the left of the score and 6 to the right of the score on one side of the tablet and M on the other side. NDC 0378-1805-77 bottles of 90 tablets NDC 0378-1805-10 bottles of 1000 tablets The 88 mcg tablets are olive, capsule-shaped, scored tablets debossed with L to the left of the score and 7 to the right of the score on one side of the tablet and M on the other side. NDC 0378-1807-77 bottles of 90 tablets NDC 0378-1807-10 bottles of 1000 tablets The 100 mcg tablets are yellow, capsule-shaped, scored tablets debossed with L to the left of the score and 8 to the right of the score on one side of the tablet and M on the other side. NDC 0378-1809-77 bottles of 90 tablets NDC 0378-1809-10 bottles of 1000 tablets The 112 mcg tablets are rose, capsule-shaped, scored tablets debossed with L to the left of the score and 9 to the right of the score on one side of the tablet and M on the other side. NDC 0378-1811-77 bottles of 90 tablets NDC 0378-1811-10 bottles of 1000 tablets The 125 mcg tablets are gray, capsule-shaped, scored tablets debossed with L to the left of the score and 10 to the right of the score on one side of the tablet and M on the other side. NDC 0378-1813-77 bottles of 90 tablets NDC 0378-1813-10 bottles of 1000 tablets The 137 mcg tablets are turquoise, capsule-shaped, scored tablets debossed with L to the left of the score and 15 to the right of the score on one side of the tablet and M on the other side. NDC 0378-1823-77 bottles of 90 tablets NDC 0378-1823-10 bottles of 1000 tablets The 150 mcg tablets are blue, capsule-shaped, scored tablets debossed with L to the left of the score and 11 to the right of the score on one side of the tablet and M on the other side. NDC 0378-1815-77 bottles of 90 tablets NDC 0378-1815-10 bottles of 1000 tablets The 175 mcg tablets are lilac, capsule-shaped, scored tablets debossed with L to the left of the score and 12 to the right of the score on one side of the tablet and M on the other side. NDC 0378-1817-77 bottles of 90 tablets NDC 0378-1817-10 bottles of 1000 tablets The 200 mcg tablets are pink, capsule-shaped, scored tablets debossed with L to the left of the score and 13 to the right of the score on one side of the tablet and M on the other side. NDC 0378-1819-77 bottles of 90 tablets NDC 0378-1819-10 bottles of 1000 tablets The 300 mcg tablets are green, capsule-shaped, scored tablets debossed with L to the left of the score and 14 to the right of the score on one side of the tablet and M on the other side. NDC 0378-1821-77 bottles of 90 tablets Storage Conditions: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.


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