levothyroxine sodium
levothyroxine sodium is listed in the FDA National Drug Code directory with 50 NDC codes, marketed under brand names including Tirosint, LEVOTHYROXINE SODIUM, ERMEZA. Available dosage forms: capsule, tablet, solution, injection, powder, lyophilized, for solution.
Drug Details
- Generic Name
- levothyroxine sodium
- Brand Names
- Tirosint, LEVOTHYROXINE SODIUM, ERMEZA, levothyroxine sodium, Levothyroxine Sodium, LEVOXYL, EUTHYROX
- Application Number
- NDA021924
- Sponsor
- IBSA Pharma Inc.
- NDC Codes
- 50
- Dosage Forms
- CAPSULE, TABLET, SOLUTION, INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Routes
- ORAL, INTRAVENOUS
- Active Ingredients
- LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS
Indications and Usage
1 INDICATION AND USAGE TIROSINT is L-thyroxine (T4) indicated for adults and pediatric patients 6 years and older with: 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 ( 1 ) Not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis ( 1 ) Hypothyroidism TIROSINT is indicated as a replacement therapy in adults and pediatric patients 6 years and older with primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression TIROSINT is indicated as an adjunct to surgery and radioiodine therapy in the management of adults and pediatric patients 6 years and older with thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: TIROSINT is 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 TIROSINT may induce hyperthyroidism [see Warnings and Precautions (5.4) ]. TIROSINT is not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis.