Levothyroxine Sodium
Tablet · Oral, Intravenous
Uses
Levothyroxine Sodium for Injection is indicated for the treatment of myxedema coma. Important Limitations of Use: The relative bioavailability between Levothyroxine Sodium for Injection and oral levothyroxine products has not been established. Caution should be used when switching patients from oral levothyroxine products to Levothyroxine Sodium for Injection as accurate dosing conversion has not been studied. Levothyroxine Sodium is an L-thyroxine product. Levothyroxine (T 4 ) Sodium for Injection is indicated for the treatment of myxedema coma. ( 1 ) Important Limitations of Use: The relative bioavailability of this drug has not been established. Use caution when converting patients from oral to intravenous levothyroxine.
Dosage and administration
• An initial intravenous loading dose of Levothyroxine Sodium for Injection between 300 to 500 mcg followed by once daily intravenous maintenance doses between 50 and 100 mcg should be administered, as clinically indicated, until the patient can tolerate oral therapy. ( 2.1 )
• Reconstitute the lyophilized Levothyroxine Sodium for Injection by aseptically adding 5 mL of 0.9% Sodium Chloride Injection, USP. Shake vial to ensure complete mixing. Reconstituted drug product is preservative free. Use immediately after reconstitution. Discard any unused portion. ( 2.3 )
• Do not add to other IV fluids. ( 2.3 ) 2.1 Dosage An initial intravenous loading dose of Levothyroxine Sodium for Injection between 300 to 500 mcg, followed by once daily intravenous maintenance doses between 50 and 100 mcg, should be administered, as clinically indicated, until the patient can tolerate oral therapy. The age, general physical condition, cardiac risk factors, and clinical severity of myxedema and duration of myxedema symptoms should be considered when determining the starting and maintenance dosages of Levothyroxine Sodium for Injection. Levothyroxine Sodium for Injection produces a gradual increase in the circulating concentrations of the hormone with an approximate half-life of 9 to 10 days in hypothyroid patients. Daily administration of Levothyroxine Sodium for Injection should be maintained until the patient is capable of tolerating an oral dose and is clinically stable. For chronic treatment of hypothyroidism, an oral dosage form of levothyroxine should be used to maintain a euthyroid state. Relative bioavailability between Levothyroxine Sodium for Injection and oral levothyroxine products has not been established. Based on medical practice, the relative bioavailability between oral and intravenous administration of Levothyroxine Sodium for Injection is estimated to be from 48 to 74%. Due to differences in absorption characteristics of patients and the oral levothyroxine product formulations, TSH and thyroid hormone levels should be measured a few weeks after initiating oral levothyroxine and dose adjusted accordingly. 2.2 Dosing in the Elderly and in Patients with Cardiovascular Disease Intravenous levothyroxine may be associated with cardiac toxicity–including arrhythmias, tachycardia, myocardial ischemia and infarction, or worsening of congestive heart failure and death–in the elderly and in those with underlying cardiovascular disease. Therefore, cautious use, including doses in the lower end of the recommended range, may be warranted in these populations. 2.3 Reconstitution Directions Reconstitute the lyophilized Levothyroxine Sodium for Injection by aseptically adding 5 mL of 0.9% Sodium Chloride Injection, USP only. Shake vial to ensure complete mixing. The resultant solution will have a final concentration of approximately 20 mcg per mL, 40 mcg per mL and 100 mcg per mL for the 100 mcg, 200 mcg and 500 mcg vials, respectively. Reconstituted drug product is preservative free and is stable for 4 hours. Discard any unused portion. DO NOT ADD LEVOTHYROXINE SODIUM FOR INJECTION TO OTHER IV FLUIDS. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. 2.1 Dosage An initial intravenous loading dose of Levothyroxine Sodium for Injection between 300 to 500 mcg, followed by once daily intravenous maintenance doses between 50 and 100 mcg, should be administered, as clinically indicated, until the patient can tolerate oral therapy. The age, general physical condition, cardiac risk factors, and clinical severity of myxedema and duration of myxedema symptoms should be considered when determining the starting and maintenance dosages of Levothyroxine Sodium for Injection. Levothyroxine Sodium for Injection produces a gradual increase in the circulating concentrations of the hormone with an approximate half-life of 9 to 10 days in hypothyroid patients. Daily administration of Levothyroxine Sodium for Injection should be maintained until the patient is capable of tolerating an oral dose and is clinically stable. For chronic treatment of hypothyroidism, an oral dosage form of levothyroxine should be used to maintain a euthyroid state. Relative bioavailability between Levothyroxine Sodium for Injection and oral levothyroxine products has not been established. Based on medical practice, the relative bioavailability between oral and intravenous administration of Levothyroxine Sodium for Injection is estimated to be from 48 to 74%. Due to differences in absorption characteristics of patients and the oral levothyroxine product formulations, TSH and thyroid hormone levels should be measured a few weeks after initiating oral levothyroxine and dose adjusted accordingly. 2.2 Dosing in the Elderly and in Patients with Cardiovascular Disease Intravenous levothyroxine may be associated with cardiac toxicity–including arrhythmias, tachycardia, myocardial ischemia and infarction, or worsening of congestive heart failure and death–in the elderly and in those with underlying cardiovascular disease. Therefore, cautious use, including doses in the lower end of the recommended range, may be warranted in these populations. 2.3 Reconstitution Directions Reconstitute the lyophilized Levothyroxine Sodium for Injection by aseptically adding 5 mL of 0.9% Sodium Chloride Injection, USP only. Shake vial to ensure complete mixing. The resultant solution will have a final concentration of approximately 20 mcg per mL, 40 mcg per mL and 100 mcg per mL for the 100 mcg, 200 mcg and 500 mcg vials, respectively. Reconstituted drug product is preservative free and is stable for 4 hours. Discard any unused portion. DO NOT ADD LEVOTHYROXINE SODIUM FOR INJECTION TO OTHER IV FLUIDS. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Dosage forms and strengths
Levothyroxine Sodium for Injection is supplied as a lyophilized powder at three strengths in single dose amber-colored vials: 100 mcg, 200 mcg and 500 mcg. Lyophilized powder for injection in single dose vials: 100 mcg, 200 mcg and 500 mcg. ( 3 )
Contraindications
None. None.
Warnings and precautions
• Excessive bolus doses of Levothyroxine Sodium for Injection (> 500 mcg) are associated with cardiac complications, particularly in the elderly and in patients with an underlying cardiac condition. Initiate therapy with doses at the lower end of the recommended range. ( 5.1 )
• Close observation of the patient following the administration of Levothyroxine Sodium for Injection is advised. ( 5.1 )
• Levothyroxine Sodium for Injection therapy for patients with previously undiagnosed endocrine disorders, including adrenal insufficiency, hypopituitarism, and diabetes insipidus, may worsen symptoms of these endocrinopathies. ( 5.2 ) 5.1 Risk of Cardiac Complications in Elderly and in Patients with Cardiovascular Disease Excessive bolus dosing of Levothyroxine Sodium for Injection (greater than 500 mcg) are associated with cardiac complications, particularly in the elderly and in patients with an underlying cardiac condition. Adverse events that can potentially be related to the administration of large doses of Levothyroxine Sodium for Injection include arrhythmias, tachycardia, myocardial ischemia and infarction, or worsening of congestive heart failure and death. Cautious use, including doses in the lower end of the recommended range, may be warranted in these populations. Close observation of the patient following the administration of Levothyroxine Sodium for Injection is advised. 5.2 Need for Concomitant Glucocorticoids and Monitoring for Other Diseases in Patients with Endocrine Disorders Occasionally, chronic autoimmune thyroiditis, which can lead to myxedema coma, may occur in association with other autoimmune disorders such as adrenal insufficiency, pernicious anemia, and insulin‑dependent diabetes mellitus. Patients should be treated with replacement glucocorticoids prior to initiation of treatment with Levothyroxine Sodium for Injection, until adrenal function has been adequately assessed. Failure to do so may precipitate an acute adrenal crisis when thyroid hormone therapy is initiated, due to increased metabolic clearance of glucocorticoids by thyroid hormone. With initiation of Levothyroxine Sodium for Injection, patients with myxedema coma should also be monitored for previously undiagnosed diabetes insipidus. 5.3 Not Indicated for Treatment of Obesity Thyroid hormones, including Levothyroxine Sodium for Injection, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss. In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Larger doses may produce serious or even life threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects [see Adverse Reactions ( 6 ) and Overdosage ( 10 )]. 5.1 Risk of Cardiac Complications in Elderly and in Patients with Cardiovascular Disease Excessive bolus dosing of Levothyroxine Sodium for Injection (greater than 500 mcg) are associated with cardiac complications, particularly in the elderly and in patients with an underlying cardiac condition. Adverse events that can potentially be related to the administration of large doses of Levothyroxine Sodium for Injection include arrhythmias, tachycardia, myocardial ischemia and infarction, or worsening of congestive heart failure and death. Cautious use, including doses in the lower end of the recommended range, may be warranted in these populations. Close observation of the patient following the administration of Levothyroxine Sodium for Injection is advised. 5.2 Need for Concomitant Glucocorticoids and Monitoring for Other Diseases in Patients with Endocrine Disorders Occasionally, chronic autoimmune thyroiditis, which can lead to myxedema coma, may occur in association with other autoimmune disorders such as adrenal insufficiency, pernicious anemia, and insulin‑dependent diabetes mellitus. Patients should be treated with replacement glucocorticoids prior to initiation of treatment with Levothyroxine Sodium for Injection, until adrenal function has been adequately assessed. Failure to do so may precipitate an acute adrenal crisis when thyroid hormone therapy is initiated, due to increased metabolic clearance of glucocorticoids by thyroid hormone. With initiation of Levothyroxine Sodium for Injection, patients with myxedema coma should also be monitored for previously undiagnosed diabetes insipidus. 5.3 Not Indicated for Treatment of Obesity Thyroid hormones, including Levothyroxine Sodium for Injection, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss. In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Larger doses may produce serious or even life threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects [see Adverse Reactions ( 6 ) and Overdosage ( 10 )].
Side effects
ExcessI doses of levothyroxine can predispose to signs and symptoms compatible with hyperthyroidism. The signs and symptoms of thyrotoxicosis include, but are not limited to: exophthalmic goiter, weight loss, increased appetite, palpitations, nervousness, diarrhea, abdominal cramps, sweating, tachycardia, increased pulse and blood pressure, cardiac arrhythmias, angina pectoris, tremors, insomnia, heat intolerance, fever, and menstrual irregularities. Excessive doses of L-thyroxine can predispose to signs and symptoms compatible with hyperthyroidism. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug interactions
Many drugs affect thyroid hormone pharmacokinetics and metabolism (e.g., synthesis, secretion, catabolism, protein binding, and target tissue response) and may alter the therapeutic response to Levothyroxine Sodium for Injection. In addition, thyroid hormones and thyroid status have varied effects on the pharmacokinetics and actions of other drugs (see Section 12.3 ). Many drugs affect thyroid hormone pharmacokinetics and metabolism (e.g., absorption, synthesis, secretion, catabolism, protein binding, and target tissue response) and may alter the therapeutic response to Levothyroxine Sodium for Injection. ( 7 , 12.3 ) 7.1 Antidiabetic Therapy Addition of levothyroxine to antidiabetic or insulin therapy may result in increased antidiabetic agent or insulin requirements. Careful monitoring of diabetic control is recommended, especially when thyroid therapy is started, changed, or discontinued. 7.2 Oral Anticoagulants Levothyroxine increases the response to oral anticoagulant therapy. Therefore, a decrease in the dose of anticoagulant may be warranted with correction of the hypothyroid state or when the Levothyroxine Sodium for Injection dose is increased. Prothrombin time should be closely monitored to permit appropriate and timely dosage adjustments. 7.3 Digitalis Glycosides The therapeutic effects of digitalis glycosides may be reduced by levothyroxine. Serum digitalis glycoside levels may be decreased when a hypothyroid patient becomes euthyroid, necessitating an increase in the dose of digitalis glycosides. 7.4 Antidepressant Therapy Concurrent use of tricyclic (e.g., amitriptyline) or tetracyclic (e.g., maprotiline) antidepressants and levothyroxine may increase the therapeutic and toxic effects of both drugs, possibly due to increased receptor sensitivity to catecholamines. Toxic effects may include increased risk of cardiac arrhythmias and CNS stimulation; onset of action of tricyclics may be accelerated. Administration of sertraline in patients stabilized on levothyroxine may result in increased levothyroxine requirements. 7.5 Ketamine Concurrent use may produce marked hypertension and tachycardia; cautious administration to patients receiving thyroid hormone therapy is recommended. 7.6 Sympathomimetics Concurrent use may increase the effects of sympathomimetics or thyroid hormone. Thyroid hormones may increase the risk of coronary insufficiency when sympathomimetic agents are administered to patients with coronary artery disease. 7.7 Drug-Laboratory Test Interactions Changes in thyroxine binding globulin (TBG) concentration must be considered when interpreting levothyroxine and triiodothyronine values, which necessitates measurement and evaluation of unbound (free) hormone and/or determination of the free levothyroxine index. Pregnancy, infectious hepatitis, estrogens, estrogen containing oral contraceptives, and acute intermittent porphyria increase TBG concentrations. Decreases in TBG concentrations are observed in nephrosis, severe hypoproteinemia, severe liver disease, acromegaly, and after androgen or corticosteroid therapy. Familial hyper or hypo thyroxine binding globulinemias have been described, with the incidence of TBG deficiency approximating 1 in 9000. 7.1 Antidiabetic Therapy Addition of levothyroxine to antidiabetic or insulin therapy may result in increased antidiabetic agent or insulin requirements. Careful monitoring of diabetic control is recommended, especially when thyroid therapy is started, changed, or discontinued. 7.2 Oral Anticoagulants Levothyroxine increases the response to oral anticoagulant therapy. Therefore, a decrease in the dose of anticoagulant may be warranted with correction of the hypothyroid state or when the Levothyroxine Sodium for Injection dose is increased. Prothrombin time should be closely monitored to permit appropriate and timely dosage adjustments. 7.3 Digitalis Glycosides The therapeutic effects of digitalis glycosides may be reduced by levothyroxine. Serum digitalis glycoside levels may be decreased when a hypothyroid patient becomes euthyroid, necessitating an increase in the dose of digitalis glycosides. 7.4 Antidepressant Therapy Concurrent use of tricyclic (e.g., amitriptyline) or tetracyclic (e.g., maprotiline) antidepressants and levothyroxine may increase the therapeutic and toxic effects of both drugs, possibly due to increased receptor sensitivity to catecholamines. Toxic effects may include increased risk of cardiac arrhythmias and CNS stimulation; onset of action of tricyclics may be accelerated. Administration of sertraline in patients stabilized on levothyroxine may result in increased levothyroxine requirements. 7.5 Ketamine Concurrent use may produce marked hypertension and tachycardia; cautious administration to patients receiving thyroid hormone therapy is recommended. 7.6 Sympathomimetics Concurrent use may increase the effects of sympathomimetics or thyroid hormone. Thyroid hormones may increase the risk of coronary insufficiency when sympathomimetic agents are administered to patients with coronary artery disease. 7.7 Drug-Laboratory Test Interactions Changes in thyroxine binding globulin (TBG) concentration must be considered when interpreting levothyroxine and triiodothyronine values, which necessitates measurement and evaluation of unbound (free) hormone and/or determination of the free levothyroxine index. Pregnancy, infectious hepatitis, estrogens, estrogen containing oral contraceptives, and acute intermittent porphyria increase TBG concentrations. Decreases in TBG concentrations are observed in nephrosis, severe hypoproteinemia, severe liver disease, acromegaly, and after androgen or corticosteroid therapy. Familial hyper or hypo thyroxine binding globulinemias have been described, with the incidence of TBG deficiency approximating 1 in 9000.
Use in specific populations
Elderly and those with underlying cardiovascular disease should receive doses at the lower end of the recommended range. ( 8.5 ) 8.1 Pregnancy Pregnancy Category A – There are no reported cases of Levothyroxine Sodium for Injection used to treat myxedema coma in patients who were pregnant or lactating. Studies in pregnant women treated with oral levothyroxine to maintain a euthyroid state have not shown an increased risk of fetal abnormalities. Therefore, pregnant patients who develop myxedema should be treated with Levothyroxine Sodium for Injection as the risk of nontreatment is associated with a high probability of significant morbidity or mortality to the maternal patient and the fetus. 8.2 Labor and Delivery Patients in labor who develop myxedema have not been reported in the literature. However, patients should be treated with Levothyroxine Sodium for Injection as the risk of nontreatment is associated with a high probability of significant morbidity or mortality to the maternal patient and the fetus. 8.3 Nursing Mothers Adequate replacement doses of thyroid hormones are required to maintain normal lactation. There are no reported cases of Levothyroxine Sodium for Injection used to treat myxedema coma in patients who are lactating. However, such patients should be treated with Levothyroxine Sodium for Injection as the risk of nontreatment is associated with a high probability of significant morbidity or mortality to the nursing patient. 8.4 Pediatric Use Myxedema coma is a disease of the elderly. An approved, oral dosage form of levothyroxine should be used in the pediatric patient population for maintaining a euthyroid state in non-complicated hypothyroidism. 8.5 Geriatric Use and Patients with Underlying Cardiovascular Disease See Section 2, Dosage and Administration , for full prescribing information in the geriatric patient population. Because of the increased prevalence of cardiovascular disease in the elderly, cautious use of Levothyroxine Sodium for Injection in the elderly and in patients with known cardiac risk factors is advised. Atrial fibrillation is a common side effect associated with levothyroxine treatment in the elderly [see Dosage and Administration ( 2 ) and Warnings and Precautions ( 5 )] . 8.5 Geriatric Use and Patients with Underlying Cardiovascular Disease See Section 2, Dosage and Administration , for full prescribing information in the geriatric patient population. Because of the increased prevalence of cardiovascular disease in the elderly, cautious use of Levothyroxine Sodium for Injection in the elderly and in patients with known cardiac risk factors is advised. Atrial fibrillation is a common side effect associated with levothyroxine treatment in the elderly [see Dosage and Administration ( 2 ) and Warnings and Precautions ( 5 )] .
Pregnancy
8.1 Pregnancy Pregnancy Category A – There are no reported cases of Levothyroxine Sodium for Injection used to treat myxedema coma in patients who were pregnant or lactating. Studies in pregnant women treated with oral levothyroxine to maintain a euthyroid state have not shown an increased risk of fetal abnormalities. Therefore, pregnant patients who develop myxedema should be treated with Levothyroxine Sodium for Injection as the risk of nontreatment is associated with a high probability of significant morbidity or mortality to the maternal patient and the fetus.
Pediatric use
8.4 Pediatric Use Myxedema coma is a disease of the elderly. An approved, oral dosage form of levothyroxine should be used in the pediatric patient population for maintaining a euthyroid state in non-complicated hypothyroidism.
Overdosage
In general, the signs and symptoms of overdosage with levothyroxine are those of hyperthyroidism [see Warnings and Precautions ( 5 ) and Adverse Reactions ( 6 )]. In addition, confusion and disorientation may occur. Cerebral embolism, shock, coma, and death have been reported. Excessive doses of Levothyroxine Sodium for Injection (greater than 500 mcg) are associated with cardiac complications in patients with underlying cardiac disease. Treatment of Overdosage Levothyroxine Sodium for Injection should be reduced in dose or temporarily discontinued if signs or symptoms of overdosage occur. To obtain up-to-date information about the treatment of overdose, a good resource is the certified Regional Poison Control Center. In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in the patient. In the event of an overdose, appropriate supportive treatment should be initiated as dictated by the patient’s medical status.
Description
Levothyroxine Sodium for Injection contains synthetic crystalline levothyroxine (L-thyroxine) sodium salt. Levothyroxine sodium has an empirical formula of C 15 H 10 I 4 NNaO 4 , a molecular weight of 798.85 g/mol (anhydrous), and the following structural formula: Levothyroxine Sodium for Injection is a sterile, preservative-free lyophilized powder consisting of the active ingredient, levothyroxine sodium, and the excipients dibasic sodium phosphate heptahydrate, USP; mannitol, USP; and sodium hydroxide, NF in single dose amber glass vials. Levothyroxine Sodium for Injection is available at three dosage strengths: 100 mcg per vial, 200 mcg per vial and 500 mcg per vial. levot-struc-01.jpg
Mechanism of action
12.1 Mechanism of Action Thyroid hormones exert their physiologic actions through control of DNA transcription and protein synthesis. Triiodothyronine (T 3 ) and levothyroxine (T 4 ) diffuse into the cell nucleus and bind to thyroid receptor proteins attached to DNA. This hormone nuclear receptor complex activates gene transcription and synthesis of messenger RNA and cytoplasmic proteins. The physiological actions of thyroid hormones are produced predominantly by T 3 , the majority of which (approximately 80%) is derived from T 4 by deiodination in peripheral tissues.
How supplied
16.1 How Supplied Levothyroxine Sodium for Injection is available in three dosage strengths. Product Code Unit of Sale Strength Reconstituted Concentration Each PA506107 NDC 42023-201-01 Individually Packaged 100 mcg per vial 20 mcg per mL NDC 42023-201-01 Vial PA506247 NDC 42023-202-01 Individually Packaged 200 mcg per vial 40 mcg per mL NDC 42023-202-01 Vial PA506248 NDC 42023-203-01 Individually Packaged 500 mcg per vial 100 mcg per mL NDC 42023-203-01 Vial 16.2 Storage and Handling Protect from light and store dry product at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Reconstituted drug product is preservative free. Discard any unused portion. The container closure is not made with natural rubber latex. Manufactured for: Endo USA Malvern, PA 19355 451495A OS201J-01-23-02 levot-img-01.jpg 16.1 How Supplied Levothyroxine Sodium for Injection is available in three dosage strengths. Product Code Unit of Sale Strength Reconstituted Concentration Each PA506107 NDC 42023-201-01 Individually Packaged 100 mcg per vial 20 mcg per mL NDC 42023-201-01 Vial PA506247 NDC 42023-202-01 Individually Packaged 200 mcg per vial 40 mcg per mL NDC 42023-202-01 Vial PA506248 NDC 42023-203-01 Individually Packaged 500 mcg per vial 100 mcg per mL NDC 42023-203-01 Vial 16.2 Storage and Handling Protect from light and store dry product at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Reconstituted drug product is preservative free. Discard any unused portion. The container closure is not made with natural rubber latex. Manufactured for: Endo USA Malvern, PA 19355 451495A OS201J-01-23-02 levot-img-01.jpg
Label text from the FDA structured product label by ENDO USA, Inc. (revised Apr 28, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Levothyroxine Sodium in 502 products
- Levothyroxine Sodium Anhydrous in 22 products
Levothyroxine Sodium NDC products (524)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-8062 | Levothyroxine Sodium 100 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7608 | Levothyroxine Sodium 88 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7566 | Levothyroxine Sodium .175 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7565 | Levothyroxine Sodium .175 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7563 | Levothyroxine Sodium 50 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7562 | Levothyroxine Sodium 50 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7527 | Levothyroxine Sodium 112 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7526 | Levothyroxine Sodium 112 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-8059 | Levothyroxine Sodium 200 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-8060 | Levothyroxine Sodium 50 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7609 | Levothyroxine Sodium 88 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-8065 | Levothyroxine Sodium 112 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-8066 | Levothyroxine Sodium 25 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-8068 | Levothyroxine Sodium 175 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-8070 | Levothyroxine Sodium 75 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-8072 | Levothyroxine Sodium 137 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7337 | Levothyroxine Sodium .1 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7336 | Levothyroxine Sodium .1 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7071 | Levothyroxine Sodium .025 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7902 | Levothyroxine Sodium 88 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7767 | Levothyroxine Sodium .137 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7801 | Levothyroxine Sodium 137 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7802 | Levothyroxine Sodium 137 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7860 | Levothyroxine Sodium 25 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7871 | Levothyroxine Sodium 88 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7885 | Levothyroxine Sodium 125 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7886 | Levothyroxine Sodium 125 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7901 | Levothyroxine Sodium 88 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6984 | Levothyroxine Sodium .088 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7909 | Levothyroxine Sodium 25 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7910 | Levothyroxine Sodium 25 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7937 | Levothyroxine Sodium 200 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-8056 | Levothyroxine Sodium 125 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7649 | Levothyroxine Sodium 100 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7648 | Levothyroxine Sodium 100 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7637 | Levothyroxine Sodium 150 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7636 | Levothyroxine Sodium 150 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6572 | Levothyroxine Sodium .05 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6100 | Levothyroxine Sodium 125 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6101 | Levothyroxine Sodium 100 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6103 | Levothyroxine Sodium 112 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6104 | Levothyroxine Sodium 150 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6105 | Levothyroxine Sodium 200 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6115 | Levothyroxine Sodium 175 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6116 | Levothyroxine Sodium 25 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6118 | Levothyroxine Sodium 75 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6119 | Levothyroxine Sodium 75 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6569 | Levothyroxine Sodium .05 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6983 | Levothyroxine Sodium .125 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6880 | Levothyroxine Sodium .112 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6579 | Levothyroxine Sodium 100 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6879 | Levothyroxine Sodium .112 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6602 | Levothyroxine Sodium 112 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6610 | Levothyroxine Sodium 150 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6634 | Levothyroxine Sodium 175 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6660 | Levothyroxine Sodium 50 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6824 | Levothyroxine Sodium .075 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6825 | Levothyroxine Sodium .075 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6982 | Levothyroxine Sodium .125 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6981 | Levothyroxine Sodium 125 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-4947 | Levothyroxine Sodium .025 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-4951 | Levothyroxine Sodium .088 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6919 | Levothyroxine Sodium 137 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6885 | Levothyroxine Sodium .15 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6884 | Levothyroxine Sodium .15 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-5792 | Levothyroxine Sodium .137 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6087 | Levothyroxine Sodium 88 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6089 | Levothyroxine Sodium 137 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6090 | Levothyroxine Sodium 50 ug/1 Tablet | A-S Medication Solutions | ANDA |
| 16729-455 | Levothyroxine Sodium 150 ug/1 Tablet | Accord Healthcare Inc. | ANDA |
| 16729-447 | Levothyroxine Sodium 25 ug/1 Tablet | Accord Healthcare Inc. | ANDA |
| 16729-448 | Levothyroxine Sodium 50 ug/1 Tablet | Accord Healthcare Inc. | ANDA |
| 16729-449 | Levothyroxine Sodium 75 ug/1 Tablet | Accord Healthcare Inc. | ANDA |
| 16729-450 | Levothyroxine Sodium 88 ug/1 Tablet | Accord Healthcare Inc. | ANDA |
| 16729-451 | Levothyroxine Sodium 100 ug/1 Tablet | Accord Healthcare Inc. | ANDA |
| 16729-452 | Levothyroxine Sodium 112 ug/1 Tablet | Accord Healthcare Inc. | ANDA |
| 16729-453 | Levothyroxine Sodium 125 ug/1 Tablet | Accord Healthcare Inc. | ANDA |
| 16729-458 | Levothyroxine Sodium 300 ug/1 Tablet | Accord Healthcare Inc. | ANDA |
| 16729-457 | Levothyroxine Sodium 200 ug/1 Tablet | Accord Healthcare Inc. | ANDA |
| 16729-456 | Levothyroxine Sodium 175 ug/1 Tablet | Accord Healthcare Inc. | ANDA |
| 16729-454 | Levothyroxine Sodium 137 ug/1 Tablet | Accord Healthcare Inc. | ANDA |
| 60687-475 | Levothyroxine Sodium .075 mg/1 Tablet | American Health Packaging | ANDA |
| 60687-530 | Levothyroxine Sodium .15 mg/1 Tablet | American Health Packaging | ANDA |
| 60687-486 | Levothyroxine Sodium .088 mg/1 Tablet | American Health Packaging | ANDA |
| 60687-497 | Levothyroxine Sodium .1 mg/1 Tablet | American Health Packaging | ANDA |
| 60687-464 | Levothyroxine Sodium .05 mg/1 Tablet | American Health Packaging | ANDA |
| 60687-453 | Levothyroxine Sodium .025 mg/1 Tablet | American Health Packaging | ANDA |
| 60687-508 | Levothyroxine Sodium .112 mg/1 Tablet | American Health Packaging | ANDA |
| 60687-563 | Levothyroxine Sodium .137 mg/1 Tablet | American Health Packaging | ANDA |
| 60687-552 | Levothyroxine Sodium .2 mg/1 Tablet | American Health Packaging | ANDA |
| 60687-541 | Levothyroxine Sodium .175 mg/1 Tablet | American Health Packaging | ANDA |
| 60687-519 | Levothyroxine Sodium .125 mg/1 Tablet | American Health Packaging | ANDA |
| 87063-094 | Levothyroxine Sodium 300 ug/1 Tablet | ASCLEMED USA INC. | ANDA |
| 87063-093 | Levothyroxine Sodium 200 ug/1 Tablet | ASCLEMED USA INC. | ANDA |
| 87063-092 | Levothyroxine Sodium 175 ug/1 Tablet | ASCLEMED USA INC. | ANDA |
| 87063-091 | Levothyroxine Sodium 150 ug/1 Tablet | ASCLEMED USA INC. | ANDA |
| 87063-090 | Levothyroxine Sodium 137 ug/1 Tablet | ASCLEMED USA INC. | ANDA |
| 87063-089 | Levothyroxine Sodium 125 ug/1 Tablet | ASCLEMED USA INC. | ANDA |
| 87063-088 | Levothyroxine Sodium 112 ug/1 Tablet | ASCLEMED USA INC. | ANDA |
| 87063-087 | Levothyroxine Sodium 100 ug/1 Tablet | ASCLEMED USA INC. | ANDA |
| 87063-086 | Levothyroxine Sodium 88 ug/1 Tablet | ASCLEMED USA INC. | ANDA |
| 87063-085 | Levothyroxine Sodium 75 ug/1 Tablet | ASCLEMED USA INC. | ANDA |
| 87063-084 | Levothyroxine Sodium 50 ug/1 Tablet | ASCLEMED USA INC. | ANDA |
| 87063-083 | Levothyroxine Sodium 25 ug/1 Tablet | ASCLEMED USA INC. | ANDA |
| 59651-554 | Levothyroxine Sodium 137 ug/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 59651-555 | Levothyroxine Sodium 150 ug/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 59651-556 | Levothyroxine Sodium 175 ug/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 59651-558 | Levothyroxine Sodium 300 ug/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 59651-557 | Levothyroxine Sodium 200 ug/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 71335-2007 | Levothyroxine Sodium 112 ug/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-1966 | Levothyroxine Sodium 88 ug/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-1947 | Levothyroxine Sodium 150 ug/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-1945 | Levothyroxine Sodium 125 ug/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-1881 | Levothyroxine Sodium 25 ug/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-1861 | Levothyroxine Sodium 137 ug/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-1828 | Levothyroxine Sodium 175 ug/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-1827 | Levothyroxine Sodium 75 ug/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-2090 | Levothyroxine Sodium 200 ug/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-2138 | Levothyroxine Sodium 100 ug/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-2538 | Levothyroxine Sodium 88 ug/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-2549 | Levothyroxine Sodium .025 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-2562 | Levothyroxine Sodium 137 ug/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-3116 | Levothyroxine Sodium .15 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-9617 | Levothyroxine Sodium 50 ug/1 Tablet | Bryant Ranch Prepack | ANDA |
| 31722-294 | Levothyroxine Sodium .2 mg/1 Tablet | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-295 | Levothyroxine Sodium .3 mg/1 Tablet | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-293 | Levothyroxine Sodium .175 mg/1 Tablet | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-292 | Levothyroxine Sodium .15 mg/1 Tablet | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-291 | Levothyroxine Sodium .137 mg/1 Tablet | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-290 | Levothyroxine Sodium .125 mg/1 Tablet | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-289 | Levothyroxine Sodium .112 mg/1 Tablet | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-288 | Levothyroxine Sodium .1 mg/1 Tablet | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-287 | Levothyroxine Sodium .088 mg/1 Tablet | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-286 | Levothyroxine Sodium .075 mg/1 Tablet | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-285 | Levothyroxine Sodium .05 mg/1 Tablet | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-284 | Levothyroxine Sodium .025 mg/1 Tablet | Camber Pharmaceuticals, Inc. | ANDA |
| 55154-3558 | Levothyroxine Sodium .025 mg/1 Tablet | Cardinal Health 107, LLC | ANDA |
| 55154-4309 | Levothyroxine Sodium .088 mg/1 Tablet | Cardinal Health 107, LLC | ANDA |
| 55154-3559 | Levothyroxine Sodium .05 mg/1 Tablet | Cardinal Health 107, LLC | ANDA |
| 55154-3560 | Levothyroxine Sodium .075 mg/1 Tablet | Cardinal Health 107, LLC | ANDA |
| 55154-3561 | Levothyroxine Sodium .1 mg/1 Tablet | Cardinal Health 107, LLC | ANDA |
| 55154-3562 | Levothyroxine Sodium .125 mg/1 Tablet | Cardinal Health 107, LLC | ANDA |
| 55154-3563 | Levothyroxine Sodium .15 mg/1 Tablet | Cardinal Health 107, LLC | ANDA |
| 55154-5395 | Levothyroxine Sodium 75 ug/1 Tablet | Cardinal Health 107, LLC | ANDA |
| 55154-5381 | Levothyroxine Sodium 100 ug/1 Tablet | Cardinal Health 107, LLC | ANDA |
| 55154-5380 | Levothyroxine Sodium 50 ug/1 Tablet | Cardinal Health 107, LLC | ANDA |
| 55154-5362 | Levothyroxine Sodium 25 ug/1 Tablet | Cardinal Health 107, LLC | ANDA |
| 55154-4377 | Levothyroxine Sodium 150 ug/1 Tablet | Cardinal Health 107, LLC | ANDA |
| 55154-4376 | Levothyroxine Sodium 125 ug/1 Tablet | Cardinal Health 107, LLC | ANDA |
| 67046-0387 | Levothyroxine Sodium .2 mg/1 Tablet | Coupler LLC | ANDA |
| 67046-0515 | Levothyroxine Sodium .15 mg/1 Tablet | Coupler LLC | ANDA |
| 67046-0517 | Levothyroxine Sodium .175 mg/1 Tablet | Coupler LLC | ANDA |
| 67046-0569 | Levothyroxine Sodium .1 mg/1 Tablet | Coupler LLC | ANDA |
| 67046-0801 | Levothyroxine Sodium .075 mg/1 Tablet | Coupler LLC | ANDA |
| 67046-0819 | Levothyroxine Sodium .05 mg/1 Tablet | Coupler LLC | ANDA |
| 67046-0828 | Levothyroxine Sodium .025 mg/1 Tablet | Coupler LLC | ANDA |
| 67046-0951 | Levothyroxine Sodium .125 mg/1 Tablet | Coupler LLC | ANDA |
| 67046-0972 | Levothyroxine Sodium .137 mg/1 Tablet | Coupler LLC | ANDA |
| 67046-0290 | Levothyroxine Sodium .112 mg/1 Tablet | Coupler LLC | ANDA |
| 67046-1679 | Levothyroxine Sodium 100 ug/1 Tablet | Coupler LLC | ANDA |
| 72189-346 | Levothyroxine Sodium 200 ug/1 Tablet | Direct Rx | ANDA |
| 72189-107 | Levothyroxine Sodium .075 mg/1 Tablet | DIRECT RX | ANDA |
| 72189-604 | Levothyroxine Sodium 88 ug/1 Tablet | Direct_rx | ANDA |
| 72189-605 | Levothyroxine Sodium 112 ug/1 Tablet | Direct_Rx | ANDA |
| 72266-261 | Levothyroxine Sodium Anhydrous 100 ug/5mL Injection, Powder, Lyophilized, For Solution | Fosun Pharma USA Inc. | ANDA |
| 68180-969 | Levothyroxine Sodium .1 mg/1 Tablet | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-976 | Levothyroxine Sodium .3 mg/1 Tablet | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-975 | Levothyroxine Sodium .2 mg/1 Tablet | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-974 | Levothyroxine Sodium .175 mg/1 Tablet | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-973 | Levothyroxine Sodium .15 mg/1 Tablet | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-972 | Levothyroxine Sodium .137 mg/1 Tablet | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-971 | Levothyroxine Sodium .125 mg/1 Tablet | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-970 | Levothyroxine Sodium .112 mg/1 Tablet | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-968 | Levothyroxine Sodium .088 mg/1 Tablet | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-967 | Levothyroxine Sodium .075 mg/1 Tablet | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-965 | Levothyroxine Sodium .025 mg/1 Tablet | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-966 | Levothyroxine Sodium .05 mg/1 Tablet | Lupin Pharmaceuticals, Inc. | ANDA |
| 33342-394 | Levothyroxine Sodium 50 ug/1 Tablet | Macleods Pharmaceuticals Limited | ANDA |
| 33342-393 | Levothyroxine Sodium 25 ug/1 Tablet | Macleods Pharmaceuticals Limited | ANDA |
| 33342-396 | Levothyroxine Sodium 88 ug/1 Tablet | Macleods Pharmaceuticals Limited | ANDA |
| 33342-397 | Levothyroxine Sodium 100 ug/1 Tablet | Macleods Pharmaceuticals Limited | ANDA |
| 33342-398 | Levothyroxine Sodium 112 ug/1 Tablet | Macleods Pharmaceuticals Limited | ANDA |
| 33342-399 | Levothyroxine Sodium 125 ug/1 Tablet | Macleods Pharmaceuticals Limited | ANDA |
| 33342-395 | Levothyroxine Sodium 75 ug/1 Tablet | Macleods Pharmaceuticals Limited | ANDA |
| 33342-400 | Levothyroxine Sodium 137 ug/1 Tablet | Macleods Pharmaceuticals Limited | ANDA |
| 33342-401 | Levothyroxine Sodium 150 ug/1 Tablet | Macleods Pharmaceuticals Limited | ANDA |
| 33342-404 | Levothyroxine Sodium 300 ug/1 Tablet | Macleods Pharmaceuticals Limited | ANDA |
| 33342-403 | Levothyroxine Sodium 200 ug/1 Tablet | Macleods Pharmaceuticals Limited | ANDA |
| 33342-402 | Levothyroxine Sodium 175 ug/1 Tablet | Macleods Pharmaceuticals Limited | ANDA |
| 70511-111 | Levothyroxine Sodium Anhydrous 100 ug/5mL Injection, Powder, Lyophilized, For Solution | MAIA Pharmaceuticals, Inc. | ANDA |
| 70511-112 | Levothyroxine Sodium Anhydrous 200 ug/5mL Injection, Powder, Lyophilized, For Solution | MAIA Pharmaceuticals, Inc. | ANDA |
| 70511-113 | Levothyroxine Sodium Anhydrous 500 ug/5mL Injection, Powder, Lyophilized, For Solution | MAIA Pharmaceuticals, Inc. | ANDA |
| 0904-6952 | Levothyroxine Sodium .088 mg/1 Tablet | Major Pharmaceuticals | ANDA |
| 0904-6949 | Levothyroxine Sodium .025 mg/1 Tablet | Major Pharmaceuticals | ANDA |
| 0904-6950 | Levothyroxine Sodium .05 mg/1 Tablet | Major Pharmaceuticals | ANDA |
| 0904-6953 | Levothyroxine Sodium .1 mg/1 Tablet | Major Pharmaceuticals | ANDA |
| 0904-6957 | Levothyroxine Sodium .175 mg/1 Tablet | Major Pharmaceuticals | ANDA |
| 0904-6956 | Levothyroxine Sodium .15 mg/1 Tablet | Major Pharmaceuticals | ANDA |
| 0904-6955 | Levothyroxine Sodium .125 mg/1 Tablet | Major Pharmaceuticals | ANDA |
| 0904-6954 | Levothyroxine Sodium .112 mg/1 Tablet | Major Pharmaceuticals | ANDA |
| 0904-6951 | Levothyroxine Sodium .075 mg/1 Tablet | Major Pharmaceuticals | ANDA |
| 51079-442 | Levothyroxine Sodium 100 ug/1 Tablet | Mylan Institutional Inc. | ANDA |
| 51079-441 | Levothyroxine Sodium 75 ug/1 Tablet | Mylan Institutional Inc. | ANDA |
| 51079-440 | Levothyroxine Sodium 50 ug/1 Tablet | Mylan Institutional Inc. | ANDA |
| 51079-443 | Levothyroxine Sodium 125 ug/1 Tablet | Mylan Institutional Inc. | ANDA |
| 51079-444 | Levothyroxine Sodium 25 ug/1 Tablet | Mylan Institutional Inc. | ANDA |
| 51079-445 | Levothyroxine Sodium 150 ug/1 Tablet | Mylan Institutional Inc. | ANDA |
| 42292-038 | Levothyroxine Sodium 88 ug/1 Tablet | Mylan Institutional Inc. | ANDA |
| 42292-039 | Levothyroxine Sodium 112 ug/1 Tablet | Mylan Institutional Inc. | ANDA |
| 42292-040 | Levothyroxine Sodium 175 ug/1 Tablet | Mylan Institutional Inc. | ANDA |
| 42292-041 | Levothyroxine Sodium 137 ug/1 Tablet | Mylan Institutional Inc. | ANDA |
| 0378-1803 | Levothyroxine Sodium 50 ug/1 Tablet | Mylan Pharmaceuticals Inc. | ANDA |
| 0378-1800 | Levothyroxine Sodium 25 ug/1 Tablet | Mylan Pharmaceuticals Inc. | ANDA |
| 0378-1805 | Levothyroxine Sodium 75 ug/1 Tablet | Mylan Pharmaceuticals Inc. | ANDA |
| 0378-1807 | Levothyroxine Sodium 88 ug/1 Tablet | Mylan Pharmaceuticals Inc. | ANDA |
| 0378-1809 | Levothyroxine Sodium 100 ug/1 Tablet | Mylan Pharmaceuticals Inc. | ANDA |
| 0378-1811 | Levothyroxine Sodium 112 ug/1 Tablet | Mylan Pharmaceuticals Inc. | ANDA |
| 0378-1823 | Levothyroxine Sodium 137 ug/1 Tablet | Mylan Pharmaceuticals Inc. | ANDA |
| 0378-1821 | Levothyroxine Sodium 300 ug/1 Tablet | Mylan Pharmaceuticals Inc. | ANDA |
| 0378-1813 | Levothyroxine Sodium 125 ug/1 Tablet | Mylan Pharmaceuticals Inc. | ANDA |
| 0378-1819 | Levothyroxine Sodium 200 ug/1 Tablet | Mylan Pharmaceuticals Inc. | ANDA |
| 0378-1817 | Levothyroxine Sodium 175 ug/1 Tablet | Mylan Pharmaceuticals Inc. | ANDA |
| 0378-1815 | Levothyroxine Sodium 150 ug/1 Tablet | Mylan Pharmaceuticals Inc. | ANDA |
| 72603-701 | Levothyroxine Sodium 200 ug/1 Tablet | NorthStar RxLLC | ANDA |
| 72603-661 | Levothyroxine Sodium 50 ug/1 Tablet | NorthStar RxLLC | ANDA |
| 72603-669 | Levothyroxine Sodium 175 ug/1 Tablet | NorthStar RxLLC | ANDA |
| 72603-668 | Levothyroxine Sodium 150 ug/1 Tablet | NorthStar RxLLC | ANDA |
| 72603-667 | Levothyroxine Sodium 137 ug/1 Tablet | NorthStar RxLLC | ANDA |
| 72603-666 | Levothyroxine Sodium 125 ug/1 Tablet | NorthStar RxLLC | ANDA |
| 72603-665 | Levothyroxine Sodium 112 ug/1 Tablet | NorthStar RxLLC | ANDA |
| 72603-664 | Levothyroxine Sodium 100 ug/1 Tablet | NorthStar RxLLC | ANDA |
| 72603-663 | Levothyroxine Sodium 88 ug/1 Tablet | NorthStar RxLLC | ANDA |
| 72603-662 | Levothyroxine Sodium 75 ug/1 Tablet | NorthStar RxLLC | ANDA |
| 72603-660 | Levothyroxine Sodium 25 ug/1 Tablet | NorthStar RxLLC | ANDA |
| 51655-742 | Levothyroxine Sodium 100 ug/1 Tablet | Northwind Health Company, LLC | ANDA |
| 51655-739 | Levothyroxine Sodium 50 ug/1 Tablet | Northwind Health Company, LLC | ANDA |
| 51655-604 | Levothyroxine Sodium 112 ug/1 Tablet | Northwind Health Company, LLC | ANDA |
| 51655-997 | Levothyroxine Sodium .112 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 51655-989 | Levothyroxine Sodium .075 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 51655-985 | Levothyroxine Sodium .025 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 51655-924 | Levothyroxine Sodium .05 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 51655-479 | Levothyroxine Sodium .15 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 51655-483 | Levothyroxine Sodium .088 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 51655-484 | Levothyroxine Sodium .125 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 51655-485 | Levothyroxine Sodium .137 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 51655-923 | Levothyroxine Sodium .1 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 51655-528 | Levothyroxine Sodium .175 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 51655-529 | Levothyroxine Sodium 88 ug/1 Tablet | Northwind Health Company, LLC | ANDA |
| 51655-783 | Levothyroxine Sodium 150 ug/1 Tablet | Northwind Health Company, LLC | ANDA |
| 82868-001 | Levothyroxine Sodium .2 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 68071-3787 | Levothyroxine Sodium .2 mg/1 Tablet | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-5316 | Levothyroxine Sodium .075 mg/1 Tablet | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-3956 | Levothyroxine Sodium .025 mg/1 Tablet | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-3887 | Levothyroxine Sodium 75 ug/1 Tablet | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-3814 | Levothyroxine Sodium .088 mg/1 Tablet | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-3730 | Levothyroxine Sodium .15 mg/1 Tablet | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-3717 | Levothyroxine Sodium .1 mg/1 Tablet | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-3996 | Levothyroxine Sodium 50 ug/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-3750 | Levothyroxine Sodium .05 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-3619 | Levothyroxine Sodium 200 ug/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2531 | Levothyroxine Sodium 125 ug/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-3692 | Levothyroxine Sodium .125 mg/1 Tablet | NuCarePharmaceuticals, Inc. | ANDA |
| 83270-006 | Levothyroxine Sodium Anhydrous 100 ug/5mL Injection, Powder, Lyophilized, For Solution | ONESOURCE SPECIALTY PHARMA LIMITED | ANDA |
| 83270-008 | Levothyroxine Sodium Anhydrous 500 ug/5mL Injection, Powder, Lyophilized, For Solution | ONESOURCE SPECIALTY PHARMA LIMITED | ANDA |
| 83270-007 | Levothyroxine Sodium Anhydrous 200 ug/5mL Injection, Powder, Lyophilized, For Solution | ONESOURCE SPECIALTY PHARMA LIMITED | ANDA |
| 72789-272 | Levothyroxine Sodium 50 ug/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-297 | Levothyroxine Sodium 100 ug/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 66794-200 | Levothyroxine Sodium Anhydrous 100 ug/5mL Injection | Piramal Critical Care, Inc. | ANDA |
| 66794-201 | Levothyroxine Sodium Anhydrous 500 ug/5mL Injection | Piramal Critical Care, Inc. | ANDA |
| 68788-8811 | Levothyroxine Sodium 175 ug/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-7954 | Levothyroxine Sodium 75 ug/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-4005 | Levothyroxine Sodium 50 ug/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-4102 | Levothyroxine Sodium 175 ug/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-7911 | Levothyroxine Sodium 50 ug/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-7929 | Levothyroxine Sodium 100 ug/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-7942 | Levothyroxine Sodium 112 ug/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-7943 | Levothyroxine Sodium 88 ug/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-7944 | Levothyroxine Sodium 137 ug/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-7945 | Levothyroxine Sodium 125 ug/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-7953 | Levothyroxine Sodium 150 ug/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8807 | Levothyroxine Sodium 100 ug/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8806 | Levothyroxine Sodium 75 ug/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8793 | Levothyroxine Sodium .175 mg/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8792 | Levothyroxine Sodium 88 ug/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-7969 | Levothyroxine Sodium 25 ug/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8896 | Levothyroxine Sodium .075 mg/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8902 | Levothyroxine Sodium 200 ug/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 82804-314 | Levothyroxine Sodium .05 mg/1 Tablet | Proficient Rx LP | ANDA |
| 82804-290 | Levothyroxine Sodium .1 mg/1 Tablet | Proficient Rx LP | ANDA |
| 82804-281 | Levothyroxine Sodium .088 mg/1 Tablet | Proficient Rx LP | ANDA |
| 82804-277 | Levothyroxine Sodium .112 mg/1 Tablet | Proficient Rx LP | ANDA |
| 82804-246 | Levothyroxine Sodium .125 mg/1 Tablet | Proficient Rx LP | ANDA |
| 82804-190 | Levothyroxine Sodium .15 mg/1 Tablet | Proficient Rx LP | ANDA |
| 82804-168 | Levothyroxine Sodium 25 ug/1 Tablet | Proficient Rx LP | ANDA |
| 82804-149 | Levothyroxine Sodium 50 ug/1 Tablet | Proficient Rx LP | ANDA |
| 82804-053 | Levothyroxine Sodium 75 ug/1 Tablet | Proficient Rx LP | ANDA |
| 71205-681 | Levothyroxine Sodium 125 ug/1 Tablet | Proficient Rx LP | ANDA |
| 71205-646 | Levothyroxine Sodium 50 ug/1 Tablet | Proficient Rx LP | ANDA |
| 71205-642 | Levothyroxine Sodium 100 ug/1 Tablet | Proficient Rx LP | ANDA |
| 67296-2048 | Levothyroxine Sodium 100 ug/1 Tablet | Redpharm drug | ANDA |
Levothyroxine Sodium recalls
- D-0786-2026 Sep 2, 2026 · Class II · Ongoing
Subpotent Drug - D-0775-2026 Sep 2, 2026 · Class II · Ongoing
Subpotent Drug - D-0776-2026 Sep 2, 2026 · Class II · Ongoing
Subpotent Drug - D-0777-2026 Sep 2, 2026 · Class II · Ongoing
Subpotent Drug - D-0778-2026 Sep 2, 2026 · Class II · Ongoing
Subpotent Drug - D-0779-2026 Sep 2, 2026 · Class II · Ongoing
Subpotent Drug - D-0780-2026 Sep 2, 2026 · Class II · Ongoing
Subpotent Drug - D-0781-2026 Sep 2, 2026 · Class II · Ongoing
Subpotent Drug - D-0782-2026 Sep 2, 2026 · Class II · Ongoing
Subpotent Drug - D-0783-2026 Sep 2, 2026 · Class II · Ongoing
Subpotent Drug - D-0784-2026 Sep 2, 2026 · Class II · Ongoing
Subpotent Drug - D-0785-2026 Sep 2, 2026 · Class II · Ongoing
Subpotent Drug - D-0709-2026 Jul 29, 2026 · Class II · Ongoing
Subpotent Drug - D-0700-2026 Jul 29, 2026 · Class II · Ongoing
Subpotent Drug - D-0701-2026 Jul 29, 2026 · Class II · Ongoing
Subpotent Drug - D-0702-2026 Jul 29, 2026 · Class II · Ongoing
Subpotent Drug - D-0703-2026 Jul 29, 2026 · Class II · Ongoing
Subpotent Drug - D-0704-2026 Jul 29, 2026 · Class II · Ongoing
Subpotent Drug - D-0705-2026 Jul 29, 2026 · Class II · Ongoing
Subpotent Drug - D-0706-2026 Jul 29, 2026 · Class II · Ongoing
Subpotent Drug
Frequently asked questions
What is Levothyroxine Sodium used for?
Levothyroxine Sodium for Injection is indicated for the treatment of myxedema coma. Important Limitations of Use: The relative bioavailability between Levothyroxine Sodium for Injection and oral levothyroxine products has not been established. Caution should be used when switching patients from oral levothyroxine products to Levothyroxine Sodium for Injection as accurate dosing conversion has not…
What are the side effects of Levothyroxine Sodium?
ExcessI doses of levothyroxine can predispose to signs and symptoms compatible with hyperthyroidism. The signs and symptoms of thyrotoxicosis include, but are not limited to: exophthalmic goiter, weight loss, increased appetite, palpitations, nervousness, diarrhea, abdominal cramps, sweating, tachycardia, increased pulse and blood pressure, cardiac arrhythmias, angina pectoris, tremors, insomnia,… See the full label for the complete list.
Who makes Levothyroxine Sodium?
Levothyroxine Sodium is listed by 31 labelers in the FDA NDC directory, including A-S Medication Solutions, Accord Healthcare Inc., American Health Packaging, ASCLEMED USA INC..
Has Levothyroxine Sodium been recalled?
The FDA enforcement database lists 20 recalls for Levothyroxine Sodium, most recently D-0786-2026 (class ii): Subpotent Drug