Drug Detail:Euthyrox (Levothyroxine [ lee-voe-thye-rox-een ])
Drug Class: Thyroid drugs
Highlights of Prescribing Information
EUTHYROX® (levothyroxine sodium) tablets, for oral use
Initial U.S. Approval: 2002
WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS
See full prescribing information for complete boxed warning.
- Thyroid hormones, including EUTHYROX, should not be used for the treatment of obesity or for weight loss.
- Doses beyond the range of daily hormonal requirements may produce serious or even life-threatening manifestations of toxicity (6, 10).
Indications and Usage for Euthyrox
EUTHYROX is L-thyroxine (T4) indicated in pediatric and adult patients for:
- Hypothyroidism: As replacement 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 hypothyroidism during the recovery phase of subacute thyroiditis. (1)
Euthyrox Dosage and Administration
- Administer once daily, on an empty stomach, one-half to one hour before breakfast. (2.1)
- Administer at least 4 hours before or after drugs that are known to interfere with absorption. (2.1)
- Evaluate the need for dose adjustments when regularly administering within one hour of certain foods that may affect absorption. (2.1)
- Starting dose depends on a variety of factors, including age, body weight, cardiovascular status, concomitant medical conditions (including pregnancy), concomitant medications, co-administered food, and the specific nature of the condition being treated. Peak therapeutic effect may not be attained for 4 to 6 weeks. (2.2)
- See full prescribing information for dosing in specific patient populations. (2.3)
- Adequacy of therapy determined with periodic monitoring of TSH and/or T4 as well as clinical status. (2.4)
Dosage Forms and Strengths
Tablets: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg (3)
Contraindications
- Uncorrected adrenal insufficiency. (4)
Warnings and Precautions
- Cardiac adverse reactions in the elderly and in patients with underlying cardiovascular disease: Initiate EUTHYROX at less than the full replacement dose because of the increased risk of cardiac adverse reactions, including atrial fibrillation. (2.3, 5.1, 8.5)
- Myxedema coma: Do not use oral thyroid hormone drug products to treat myxedema coma. (5.2)
- Acute adrenal crisis in patients with concomitant adrenal insufficiency: Treat with replacement glucocorticoids prior to initiation of EUTHYROX treatment. (5.3)
- Prevention of hyperthyroidism or incomplete treatment of hypothyroidism: Proper dose titration and careful monitoring is critical to prevent the persistence of hypothyroidism or the development of hyperthyroidism. (5.4)
- Worsening of diabetic control: Therapy in patients with diabetes mellitus may worsen glycemic control and result in increased antidiabetic agent or insulin requirements. Carefully monitor glycemic control after starting, changing, or discontinuing thyroid hormone therapy. (5.5)
- Decreased bone mineral density associated with thyroid hormone over-replacement: Over-replacement can increase bone resorption and decrease bone mineral density. Give the lowest effective dose. (5.6)
Adverse Reactions/Side Effects
Adverse reactions associated with EUTHYROX are primarily those of hyperthyroidism due to therapeutic overdosage: arrhythmias, myocardial infarction, dyspnea, muscle spasm, headache, nervousness, irritability, insomnia, tremors, muscle weakness, increased appetite, weight loss, diarrhea, heat intolerance, menstrual irregularities, and skin rash. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Provell Pharmaceuticals, LLC at 1-888-899-7041 or FDA at1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions
See full prescribing information for drugs that 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 EUTHYROX. (7)
Use In Specific Populations
- Pregnancy may require the use of higher doses of EUTHYROX. (2.3, 8.1)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 4/2022
Full Prescribing Information
WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS
- Thyroid hormones, including EUTHYROX, 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), Drug Interactions (7.7), and Overdosage (10)].
2. Euthyrox Dosage and Administration
2.1 General Administration Information
Administer EUTHYROX tablets orally as a single daily dose, on an empty stomach, one-half to one hour before breakfast.
Administer EUTHYROX at least 4 hours before or after drugs known to interfere with EUTHYROX absorption [see Drug Interactions (7.1)].
Evaluate the need for dose adjustments when regularly administering within one hour of certain foods that may affect EUTHYROX absorption [see Drug Interactions (7.9), Clinical Pharmacology (12.3)].
Administer EUTHYROX to infants and children who cannot swallow intact tablets by crushing the tablet, suspending the freshly crushed tablet in a small amount (5 mL to 10 mL or 1 teaspoon to 2 teaspoons) of water and immediately administering the suspension by spoon or dropper. Do not store the suspension. Do not administer in foods that decrease absorption of EUTHYROX, such as soybean-based infant formula [see Drug Interactions (7.9)].
2.2 General Principles of Dosing
The dose of EUTHYROX for hypothyroidism or pituitary TSH suppression depends on a variety of factors including: the patient's age, body weight, cardiovascular status, concomitant medical conditions (including pregnancy), concomitant medications, co-administered food and the specific nature of the condition being treated [see Dosage and Administration (2.3), Warnings and Precautions (5), Drug Interactions (7)]. Dosing must be individualized to account for these factors and dose adjustments made based on periodic assessment of the patient's clinical response and laboratory parameters [see Dosage and Administration (2.4)].
The peak therapeutic effect of a given dose of EUTHYROX may not be attained for 4 to 6 weeks.
2.3 Dosing in Specific Populations
2.4 Monitoring TSH and/or Thyroxine (T4) Levels
Assess the adequacy of therapy by periodic assessment of laboratory tests and clinical evaluation. Persistent clinical and laboratory evidence of hypothyroidism despite an apparent adequate replacement dose of EUTHYROX may be evidence of inadequate absorption, poor compliance, drug interactions, or a combination of these factors.
3. Dosage Forms and Strengths
EUTHYROX tablets are uncoated, off-white, round and flat on both sides with a beveled edge, and a dividing score on both sides available as:
| Tablet Strength | Tablet Markings |
|---|---|
| 25 mcg | "EM" and "25" |
| 50 mcg | "EM" and "50" |
| 75 mcg | "EM" and "75" |
| 88 mcg | "EM" and "88" |
| 100 mcg | "EM" and "100" |
| 112 mcg | "EM" and "112" |
| 125 mcg | "EM" and "125" |
| 137 mcg | "EM" and "137" |
| 150 mcg | "EM" and "150" |
| 175 mcg | "EM" and "175" |
| 200 mcg | "EM" and "200" |
4. Contraindications
EUTHYROX is contraindicated in patients with uncorrected adrenal insufficiency [see Warnings and Precautions (5.3)].
5. Warnings and Precautions
5.1 Cardiac Adverse Reactions in the Elderly and in Patients with Underlying Cardiovascular Disease
Overtreatment with levothyroxine may cause an increase in heart rate, cardiac wall thickness, and cardiac contractility and may precipitate angina or arrhythmias, particularly in patients with cardiovascular disease and in elderly patients. Initiate EUTHYROX therapy in this population at lower doses than those recommended in younger individuals or in patients without cardiac disease [see Dosage and Administration (2.3), Use in Specific Populations (8.5)].
Monitor for cardiac arrhythmias during surgical procedures in patients with coronary artery disease receiving suppressive EUTHYROX therapy. Monitor patients receiving concomitant EUTHYROX and sympathomimetic agents for signs and symptoms of coronary insufficiency. If cardiovascular symptoms develop or worsen, reduce or withhold the EUTHYROX dose for one week and restart at a lower dose.
5.2 Myxedema Coma
Myxedema coma is a life-threatening emergency characterized by poor circulation and hypometabolism, and may result in unpredictable absorption of levothyroxine sodium from the gastrointestinal tract. Use of oral thyroid hormone drug products is not recommended to treat myxedema coma. Administer thyroid hormone products formulated for intravenous administration to treat myxedema coma.
5.3 Acute Adrenal Crisis in Patients with Concomitant Adrenal Insufficiency
Thyroid hormone increases metabolic clearance of glucocorticoids. Initiation of thyroid hormone therapy prior to initiating glucocorticoid therapy may precipitate an acute adrenal crisis in patients with adrenal insufficiency. Treat patients with adrenal insufficiency with replacement glucocorticoids prior to initiating treatment with EUTHYROX [see Contraindications (4)].
5.4 Prevention of Hyperthyroidism or Incomplete Treatment of Hypothyroidism
EUTHYROX has a narrow therapeutic index. Over- or under-treatment with EUTHYROX may have negative effects on growth and development, cardiovascular function, bone metabolism, reproductive function, cognitive function, emotional state, gastrointestinal function, and on glucose and lipid metabolism. Titrate the dose of EUTHYROX carefully and monitor response to titration to avoid these effects [see Dosage and Administration (2.4)]. Monitor for the presence of drug or food interactions when using EUTHYROX and adjust the dose as necessary [see Drug Interactions (7), Clinical Pharmacology (12.3)].
5.5 Worsening of Diabetic Control
Addition of levothyroxine therapy in patients with diabetes mellitus may worsen glycemic control and result in increased antidiabetic agent or insulin requirements. Carefully monitor glycemic control after starting, changing, or discontinuing EUTHYROX [see Drug Interactions (7.2)].
5.6 Decreased Bone Mineral Density Associated with Thyroid Hormone Over-Replacement
Increased bone resorption and decreased bone mineral density may occur as a result of levothyroxine over-replacement, particularly in post-menopausal women. The increased bone resorption may be associated with increased serum levels and urinary excretion of calcium and phosphorous, elevations in bone alkaline phosphatase, and suppressed serum parathyroid hormone levels. Administer the minimum dose of EUTHYROX that achieves the desired clinical and biochemical response to mitigate against this risk.
6. Adverse Reactions/Side Effects
Adverse reactions associated with EUTHYROX therapy are primarily those of hyperthyroidism due to therapeutic overdosage [see Warnings and Precautions (5), Overdosage (10)]. They include the following:
- General: fatigue, increased appetite, weight loss, heat intolerance, fever, excessive sweating
- Central Nervous System: headache, hyperactivity, nervousness, anxiety, irritability, emotional lability, insomnia
- Musculoskeletal: tremors, muscular weakness and cramps
- Cardiovascular: palpitations, tachycardia, arrhythmias, increased pulse and blood pressure, heart failure, angina, myocardial infarction, cardiac arrest
- Respiratory: dyspnea
- Gastrointestinal: diarrhea, vomiting, abdominal cramps and elevations in liver function tests
- Dermatologic: hair loss, flushing, rash
- Endocrine: decreased bone mineral density
- Reproductive: menstrual irregularities, impaired fertility
Seizures have been reported rarely with levothyroxine therapy.
7. Drug Interactions
7.1 Drugs Known to Affect Thyroid Hormone Pharmacokinetics
Many drugs can exert effects on thyroid hormone pharmacokinetics (e.g. absorption, synthesis, secretion, catabolism, protein binding, and target tissue response) and may alter the therapeutic response to EUTHYROX (see Tables 2 – 5).
| Potential impact: Concurrent use may reduce the efficacy of EUTHYROX by binding and delaying or preventing absorption, potentially resulting in hypothyroidism | |
| Drug or Drug Class | Effect |
| Calcium Carbonate Ferrous Sulfate | Calcium carbonate may form an insoluble chelate with levothyroxine, and ferrous sulfate likely forms a ferric-thyroxine complex. Administer EUTHYROX at least 4 hours apart from these agents. |
| Orlistat | Monitor patients treated concomitantly with orlistat and EUTHYROX for changes in thyroid function. |
| Bile Acid Sequestrants -Colesevelam -Cholestyramine -Colestipol Ion Exchange Resins -Kayexalate -Sevelamer | Bile acid sequestrants and ion exchange resins are known to decrease levothyroxine absorption. Administer EUTHYROX at least 4 hours prior to these drugs or monitor thyrotropin (TSH) levels. |
| Other drugs: Proton Pump Inhibitors Sucralfate Antacids - Aluminum & Magnesium Hydroxides - Simethicone | Gastric acidity is an essential requirement for adequate absorption of levothyroxine. Sucralfate, antacids and proton pump inhibitors may cause hypochlorhydria, affect intragastric pH, and reduce levothyroxine absorption. Monitor patients appropriately. |
| Drug or Drug Class | Effect |
|---|---|
| Clofibrate Estrogen-containing oral contraceptives Estrogens (oral) Heroin / Methadone 5-Fluorouracil Mitotane Tamoxifen | These drugs may increase serum thyroxine-binding globulin (TBG) concentration. |
| Androgens / Anabolic Steroids Asparaginase Glucocorticoids Slow-Release Nicotinic Acid | These drugs may decrease serum TBG concentration. |
| Potential impact (below): Administration of these agents with EUTHYROX results in an initial transient increase in FT4. Continued administration results in a decrease in serum T4 and normal FT4 and TSH concentrations. | |
| Salicylates (> 2 g/day) | Salicylates inhibit binding of T4 and T3 to TBG and transthyretin. An initial increase in serum FT4 is followed by return of FT4 to normal levels with sustained therapeutic serum salicylate concentrations, although total T4 levels may decrease by as much as 30%. |
| Other drugs: Carbamazepine Furosemide (> 80 mg IV) Heparin Hydantoins Non-Steroidal Anti-inflammatory Drugs - Fenamates | These drugs may cause protein-binding site displacement. Furosemide has been shown to inhibit the protein binding of T4 to TBG and albumin, causing an increased free-T4 fraction in serum. Furosemide competes for T4-binding sites on TBG, prealbumin, and albumin, so that a single high dose can acutely lower the total T4 level. Phenytoin and carbamazepine reduce serum protein binding of levothyroxine, and total and free-T4 may be reduced by 20% to 40%, but most patients have normal serum TSH levels and are clinically euthyroid. Closely monitor thyroid hormone parameters. |
| Potential impact: Stimulation of hepatic microsomal drug-metabolizing enzyme activity may cause increased hepatic degradation of levothyroxine, resulting in increased EUTHYROX requirements. | |
| Drug or Drug Class | Effect |
| Phenobarbital Rifampin | Phenobarbital has been shown to reduce the response to thyroxine. Phenobarbital increases L-thyroxine metabolism by inducing uridine 5'-diphospho-glucuronosyltransferase (UGT) and leads to a lower T4 serum levels. Changes in thyroid status may occur if barbiturates are added or withdrawn from patients being treated for hypothyroidism. Rifampin has been shown to accelerate the metabolism of levothyroxine. |
| Potential impact: Administration of these enzyme inhibitors decreases the peripheral conversion of T4 to T3, leading to decreased T3 levels. However, serum T4 levels are usually normal but may occasionally be slightly increased. | |
| Drug or Drug Class | Effect |
| Beta-adrenergic antagonists (e.g., Propranolol > 160 mg/day) | In patients treated with large doses of propranolol (> 160 mg/day), T3 and T4 levels change, TSH levels remain normal, and patients are clinically euthyroid. Actions of particular beta-adrenergic antagonists may be impaired when the hypothyroid patient is converted to the euthyroid state. |
| Glucocorticoids (e.g., Dexamethasone ≥ 4 mg/day) | Short-term administration of large doses of glucocorticoids may decrease serum T3 concentrations by 30% with minimal change in serum T4 levels. However, long-term glucocorticoid therapy may result in slightly decreased T3 and T4 levels due to decreased TBG production (see Table 3 above). |
| Other: Amiodarone | Amiodarone inhibits peripheral conversion of levothyroxine (T4) to triiodothyronine (T3) and may cause isolated biochemical changes (increase in serum free-T4, and decrease or normal free-T3) in clinically euthyroid patients. |
7.2 Antidiabetic Therapy
Addition of EUTHYROX therapy in patients with diabetes mellitus may worsen glycemic control and result in increased antidiabetic agent or insulin requirements. Carefully monitor glycemic control, especially when EUTHYROX is started, changed, or discontinued [see Warnings and Precautions (5.5)].
7.3 Oral Anticoagulants
EUTHYROX 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 EUTHYROX dose is increased. Closely monitor coagulation tests to permit appropriate and timely dosage adjustments.
7.4 Digitalis Glycosides
EUTHYROX may reduce the therapeutic effects of digitalis glycosides. Serum digitalis glycoside levels may decrease when a hypothyroid patient becomes euthyroid, necessitating an increase in the dose of digitalis glycosides.
7.5 Antidepressant Therapy
Concurrent use of tricyclic (e.g., amitriptyline) or tetracyclic (e.g., maprotiline) antidepressants and EUTHYROX 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 central nervous system stimulation. EUTHYROX may accelerate the onset of action of tricyclics. Administration of sertraline in patients stabilized on EUTHYROX may result in increased EUTHYROX requirements.
7.6 Ketamine
Concurrent use of ketamine and EUTHYROX may produce marked hypertension and tachycardia. Closely monitor blood pressure and heart rate in these patients.
7.7 Sympathomimetics
Concurrent use of sympathomimetics and EUTHYROX 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.
7.8 Tyrosine-Kinase Inhibitors
Concurrent use of tyrosine-kinase inhibitors such as imatinib may cause hypothyroidism. Closely monitor TSH levels in such patients.
7.9 Drug-Food Interactions
Consumption of certain foods may affect EUTHYROX absorption thereby necessitating adjustments in dosing [see Dosage and Administration (2.1)]. Soybean flour (infant formula), cottonseed meal, walnuts, and dietary fiber may bind and decrease the absorption of EUTHYROX from the gastrointestinal tract. Grapefruit juice may delay the absorption of levothyroxine and reduce its bioavailability.
7.10 Drug–Laboratory Test Interactions
Consider changes in TBG concentration when interpreting T4 and T3 values. Measure and evaluate unbound (free) hormone and/or determine the free-T4 index (FT4I) in this circumstance. Pregnancy, infectious hepatitis, estrogens, estrogen containing oral contraceptives, and acute intermittent porphyria increase TBG concentrations. Nephrosis, severe hypoproteinemia, severe liver disease, acromegaly, androgens and corticosteroids decrease TBG concentration. Familial hyper- or hypo-thyroxine binding globulinemias have been described, with the incidence of TBG deficiency approximating 1 in 9000.
8. Use In Specific Populations
8.4 Pediatric Use
The initial dose of EUTHYROX varies with age and body weight. Dosing adjustments are based on an assessment of the individual patient's clinical and laboratory parameters [see Dosage and Administration (2.3,2.4)].
In children in whom a diagnosis of permanent hypothyroidism has not been established, discontinue EUTHYROX administration for a trial period, but only after the child is at least 3 years of age. Obtain serum T4 and TSH levels at the end of the trial period, and use laboratory test results and clinical assessment to guide diagnosis and treatment, if warranted.
8.5 Geriatric Use
Because of the increased prevalence of cardiovascular disease among the elderly, initiate EUTHYROX at less than the full replacement dose [see Warnings and Precautions (5.1) and Dosage and Administration (2.3)]. Atrial arrhythmias can occur in elderly patients. Atrial fibrillation is the most common of the arrhythmias observed with levothyroxine overtreatment in the elderly.
10. Overdosage
The signs and symptoms of overdosage are those of hyperthyroidism [See Warnings and Precautions (5.4) and Adverse Reactions (6)]. In addition, confusion and disorientation may occur. Cerebral embolism, shock, coma, and death have been reported. Seizures occurred in a 3 year-old child ingesting 3.6 mg levothyroxine. Symptoms may not necessarily be evident or may not appear until several days after ingestion of levothyroxine sodium.
Reduce the EUTHYROX dose or discontinue temporarily if signs or symptoms of overdosage occur. Initiate appropriate supportive treatment as dictated by the patient's medical status.
For current information on the management of poisoning or overdosage, contact the National Poison Control Center at 1-800-222-1222 or www.poison.org.
11. Euthyrox Description
EUTHYROX contains the active ingredient, levothyroxine, a synthetic 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 the molecular formula C15H10I4NNaO4 ∙ xH2O, molecular weight of 798.85 (anhydrous), and structural formula as shown:
EUTHYROX 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 citric acid anhydrous, corn starch, gelatin, magnesium stearate, mannitol, sodium croscarmellose.
12. Euthyrox - Clinical Pharmacology
12.1 Mechanism of Action
Thyroid hormones exert their physiologic actions through control of DNA transcription and protein synthesis. Triiodothyronine (T3) and L-thyroxine (T4) 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 T3, the majority of which (approximately 80%) is derived from T4 by deiodination in peripheral tissues.
12.2 Pharmacodynamics
Oral levothyroxine sodium is a synthetic T4 hormone that exerts the same physiologic effect as endogenous T4, thereby maintaining normal T4 levels when a deficiency is present.
16. How is Euthyrox supplied
EUTHYROX (levothyroxine sodium) tablets are uncoated, off-white, round and flat on both sides with a beveled edge, and a dividing score on both sides available as:
| Tablet Strength | Tablet Markings |
Carton Marking and Blister Packaging Color | NDC
30-count carton | NDC
90-count carton |
| 25 mcg | “EM” and “25” | Orange | NDC 72305-025-30 | NDC 72305-025-90 |
| 50 mcg | “EM” and “50” | White | NDC 72305-050-30 | NDC 72305-050-90 |
| 75 mcg | “EM” and “75” | Purple | NDC 72305-075-30 | NDC 72305-075-90 |
| 88 mcg | “EM” and “88” | Olive | NDC 72305-088-30 | NDC 72305-088-90 |
| 100 mcg | “EM” and “100” | Yellow | NDC 72305-100-30 | NDC 72305-100-90 |
| 112 mcg | “EM” and “112” | Rose | NDC 72305-112-30 | NDC 72305-112-90 |
| 125 mcg | “EM” and “125” | Brown | NDC 72305-125-30 | NDC 72305-125-90 |
| 137 mcg | “EM” and “137” | Turquoise | NDC 72305-137-30 | NDC 72305-137-90 |
| 150 mcg | “EM” and “150” | Blue | NDC 72305-150-30 | NDC 72305-150-90 |
| 175 mcg | “EM” and “175” | Lilac | NDC 72305-175-30 | NDC 72305-175-90 |
| 200 mcg | “EM” and “200” | Pink | NDC 72305-200-30 | NDC 72305-200-90 |
Each 30-count carton contains 30 tablets with 2 blister packs. Each 90-count carton contains 90 tablets with 6 blister packs. Each blister pack contains 15 tablets placed in individual cavities.
17. Patient Counseling Information
Inform the patient of the following information to aid in the safe and effective use of EUTHYROX:
PRINCIPAL DISPLAY PANEL - 25 mcg Tablet Blister Pack Carton
Euthyrox
(levothyroxine sodium) tablets
25 mcg per tablet, USP
Rx only
NDC 72305-025-30
Do not remove individual tablets from
blister packaging until ready to use.
30 Tablets (2 x 15 tablets per blister pack)
PROVELL
PHARMACEUTICALS LLC
PRINCIPAL DISPLAY PANEL - 50 mcg Tablet Blister Pack Carton
Euthyrox
(levothyroxine sodium) tablets
50 mcg per tablet, USP
Rx only
NDC 72305-050-30
Do not remove individual tablets from
blister packaging until ready to use.
30 Tablets (2 x 15 tablets per blister pack)
PROVELL
PHARMACEUTICALS LLC
PRINCIPAL DISPLAY PANEL - 75 mcg Tablet Blister Pack Carton
Euthyrox
(levothyroxine sodium) tablets
75 mcg per tablet, USP
Rx only
NDC 72305-075-30
Do not remove individual tablets from
blister packaging until ready to use.
30 Tablets (2 x 15 tablets per blister pack)
PROVELL
PHARMACEUTICALS LLC
PRINCIPAL DISPLAY PANEL - 88 mcg Tablet Blister Pack Carton
Euthyrox
(levothyroxine sodium) tablets
88 mcg per tablet, USP
Rx only
NDC 72305-088-30
Do not remove individual tablets from
blister packaging until ready to use.
30 Tablets (2 x 15 tablets per blister pack)
PROVELL
PHARMACEUTICALS LLC
PRINCIPAL DISPLAY PANEL - 100 mcg Tablet Blister Pack Carton
Euthyrox
(levothyroxine sodium) tablets
100 mcg per tablet, USP
Rx only
NDC 72305-100-30
Do not remove individual tablets from
blister packaging until ready to use.
30 Tablets (2 x 15 tablets per blister pack)
PROVELL
PHARMACEUTICALS LLC
PRINCIPAL DISPLAY PANEL - 112 mcg Tablet Blister Pack Carton
Euthyrox
(levothyroxine sodium) tablets
112 mcg per tablet, USP
Rx only
NDC 72305-112-30
Do not remove individual tablets from
blister packaging until ready to use.
30 Tablets (2 x 15 tablets per blister pack)
PROVELL
PHARMACEUTICALS LLC
PRINCIPAL DISPLAY PANEL - 125 mcg Tablet Blister Pack Carton
Euthyrox
(levothyroxine sodium) tablets
125 mcg per tablet, USP
Rx only
NDC 72305-125-30
Do not remove individual tablets from
blister packaging until ready to use.
30 Tablets (2 x 15 tablets per blister pack)
PROVELL
PHARMACEUTICALS LLC
PRINCIPAL DISPLAY PANEL - 137 mcg Tablet Blister Pack Carton
Euthyrox
(levothyroxine sodium) tablets
137 mcg per tablet, USP
Rx only
NDC 72305-137-30
Do not remove individual tablets from
blister packaging until ready to use.
30 Tablets (2 x 15 tablets per blister pack)
PROVELL
PHARMACEUTICALS LLC
PRINCIPAL DISPLAY PANEL - 150 mcg Tablet Blister Pack Carton
Euthyrox
(levothyroxine sodium) tablets
150 mcg per tablet, USP
Rx only
NDC 72305-150-30
Do not remove individual tablets from
blister packaging until ready to use.
30 Tablets (2 x 15 tablets per blister pack)
PROVELL
PHARMACEUTICALS LLC
PRINCIPAL DISPLAY PANEL - 175 mcg Tablet Blister Pack Carton
Euthyrox
(levothyroxine sodium) tablets
175 mcg per tablet, USP
Rx only
NDC 72305-175-30
Do not remove individual tablets from
blister packaging until ready to use.
30 Tablets (2 x 15 tablets per blister pack)
PROVELL
PHARMACEUTICALS LLC
| EUTHYROX
levothyroxine sodium tablet |
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
| EUTHYROX
levothyroxine sodium tablet |
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
| EUTHYROX
levothyroxine sodium tablet |
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
| EUTHYROX
levothyroxine sodium tablet |
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
| EUTHYROX
levothyroxine sodium tablet |
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
| EUTHYROX
levothyroxine sodium tablet |
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
| EUTHYROX
levothyroxine sodium tablet |
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
| EUTHYROX
levothyroxine sodium tablet |
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
| EUTHYROX
levothyroxine sodium tablet |
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
| EUTHYROX
levothyroxine sodium tablet |
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
| EUTHYROX
levothyroxine sodium tablet |
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
| Labeler - Provell Pharmaceuticals, LLC (624387200) |
