levothyroxine sodium 125 mcg

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 (T 4 ) 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.

Amneal Pharmaceuticals LLC

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] fatigue` `[3] nausea` `[4] off label use` `[5] pain` `[6] headache` `[7] diarrhoea` `[8] dyspnoea` `[9] arthralgia` `[10] vomiting`

6 months ago

OVAL BROWN A N L 7

16 HOW SUPPLIED/STORAGE AND HANDLING

LEVOTHYROXINE SODIUM tablets, USP, 25 mcg, are supplied as orange, capsule shaped, flat faced beveled edge tablets, scored on both sides, debossed with “A” bisect “N” on one side and “L” bisect “1” on the other side. They are available as follows: Bottles of 100: NDC 69238-1163-1

LEVOTHYROXINE SODIUM tablets, USP, 50 mcg, are supplied as white to off-white, capsule shaped, flat faced beveled edge tablets, scored on both sides, debossed with “A” bisect “N” on one side and “L” bisect “2” on the other side. They are available as follows: Bottles of 100: NDC 69238-1164-1

LEVOTHYROXINE SODIUM tablets, USP, 75 mcg, are supplied as violet, capsule shaped, flat faced beveled edge tablets, scored on both sides, debossed with “A” bisect “N” on one side and “L” bisect “3” on the other side. They are available as follows: Bottles of 100: NDC 69238-1168-1

LEVOTHYROXINE SODIUM tablets, USP, 88 mcg, are supplied as olive, capsule shaped, flat faced beveled edge tablets, scored on both sides, debossed with “A” bisect “N” on one side and “L” bisect “4” on the other side. They are available as follows: Bottles of 100: NDC 69238-1169-1

LEVOTHYROXINE SODIUM tablets, USP, 100 mcg, are supplied as yellow, capsule shaped, flat faced beveled edge tablets, scored on both sides, debossed with “A” bisect “N” on one side and “L” bisect “5” on the other side. They are available as follows: Bottles of 100: NDC 69238-1177-1

LEVOTHYROXINE SODIUM tablets, USP, 112 mcg, are supplied as dark pink, capsule shaped, flat faced beveled edge tablets, scored on both sides, debossed with “A” bisect “N” on one side and “L” bisect “6” on the other side. They are available as follows: Bottles of 100: NDC 69238-1178-1

LEVOTHYROXINE SODIUM tablets, USP, 125 mcg, are supplied as brown, capsule shaped, flat faced beveled edge tablets, scored on both sides, debossed with “A” bisect “N” on one side and “L” bisect “7” on the other side. They are available as follows: Bottles of 100: NDC 69238-1183-1

LEVOTHYROXINE SODIUM tablets, USP, 137 mcg, are supplied as turquoise, capsule shaped, flat faced beveled edge tablets, scored on both sides, debossed with “A” bisect “N” on one side and “L” bisect “8” on the other side. They are available as follows: Bottles of 100: NDC 69238-1275-1

LEVOTHYROXINE SODIUM tablets, USP, 150 mcg, are supplied as blue, capsule shaped, flat faced beveled edge tablets, scored on both sides, debossed with “A” bisect “N” on one side and “L” bisect “9” on the other side. They are available as follows: Bottles of 100: NDC 69238-1276-1

LEVOTHYROXINE SODIUM tablets, USP, 175 mcg, are supplied as lilac, capsule shaped, flat faced beveled edge tablets, scored on both sides, debossed with “A” bisect “N” on one side and “L” bisect “10” on the other side. They are available as follows: Bottles of 100: NDC 69238-1277-1

LEVOTHYROXINE SODIUM tablets, USP, 200 mcg, are supplied as pink, capsule shaped, flat faced beveled edge tablets, scored on both sides, debossed with “A” bisect “N” on one side and “L” bisect “11” on the other side. They are available as follows: Bottles of 100: NDC 69238-1278-1

LEVOTHYROXINE SODIUM tablets, USP, 300 mcg, are supplied as green, capsule shaped, flat faced beveled edge tablets, scored on both sides, debossed with “A” bisect “N” on one side and “L” bisect “12” on the other side. They are available as follows: Bottles of 100: NDC 69238-1279-1 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

LEVOTHYROXINE SODIUM tablets, USP should be protected from light and moisture.

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