Levothyroxine Sodium .1 mg Tablet, 90-count
Other active recalls for Levothyroxine Sodium (different manufacturers) — 6 · tap to view
Past resolved recalls for this product (1)
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the l-Thyroxine class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
- Your thyroid gland isn't making enough of a hormone called T4, which your whole body depends on to regulate your energy, metabolism, heart rate, and more. Levothyroxine is a precis...
- What exactly is levothyroxine doing for me — why do I need to take it every day?
- Timing really does make a difference with this medication. Food — especially high-fiber foods or anything soy-based — can block your gut from absorbing it properly. Taking it 30 to...
- Why does it matter so much when I take it — can't I just take it with breakfast?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Levothyroxine Sodium — tap one for details:
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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UNII 35SW5USQ3G
A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
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UNII H77VEI93A8
A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
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UNII 8MDF5V39QO
A white powder form of baking soda that acts as a buffer and pH regulator in medicines. It helps maintain the right acid-base balance and may aid tablet disintegration.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
7 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.051 | $4.56 / 90 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.2353 | $21.18 / 90 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.1283 | $11.55 / 90 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Levothyroxine Sodium 100 ug 00378-1809-10 | Mylan | 1000 tablets | $0.051 | AB1,AB2,AB3,AB4 | Availability likely | — |
| Levothyroxine Sodium 100 ug 00527-3284-43 | Lannett | 1000 tablets | $0.051 | AB1,AB2,AB3 | Availability likely | — |
| Levothyroxine Sodium .1 mg 00904-6953-61 | Major | 100 tablets | $0.051 | AB1,AB2,AB3 | Availability likely | — |
| Levothyroxine sodium 100 ug 16729-0451-15 | Accord | 90 tablets | $0.051 | AB1,AB2,AB3,AB4 | Availability likely | — |
| Levothyroxine Sodium 100 ug 33342-0397-10 | Macleods | 90 tablets | $0.051 | AB1,AB2,AB3,AB4 | Availability likely | — |
| levothyroxine sodium 100 ug 47781-0651-10 | Alvogen, | 1000 tablets | $0.051 | AB1,AB2,AB3,AB4 | Availability likely | — |
| Levothyroxine Sodium 100 ug 51079-0442-20 | Mylan | 100 tablets | $0.051 | AB1,AB2,AB3,AB4 | Availability likely | — |
| Levothyroxine Sodium .1 mg 60687-0497-01 | American | 100 tablets | $0.051 | AB1,AB2,AB3 | Availability likely | — |
| Levothyroxine Sodium .1 mgthis 68180-0969-09 | Lupin | 90 tablets | $0.051 | AB1,AB2,AB3 | Availability likely | — |
| Levothyroxine Sodium .1 mg 69238-1834-01 | Amneal | 100 tablets | $0.051 | AB1,AB2,AB3 | Availability likely | — |
| Levothyroxine Sodium 100 ug 72603-0664-01 | NorthStar | 90 tablets | $0.051 | AB1,AB2,AB3,AB4 | Availability likely | — |
| Levoxyl 100 ug 60793-0854-01 | Pfizer | 100 tablets | $0.970 | AB1,AB3 | Availability likely | +1811% |
| Synthroid 100 ug 00074-6624-11 | AbbVie | 100 tablets | $1.662 | AB1,AB2 | Availability likely | +3177% |
| Unithroid 100 ug 60846-0805-01 | Amneal | 100 tablets | $4.208 | AB1,AB2,AB3 | Availability likely | +8194% |
| Levothyroxine sodium 100 ug 00480-8701-01 | Teva | 100 tablets | — | AB1,AB2,AB3,AB4 | Discontinued | — |
| Levothyroxine Sodium .1 mg 00615-8599-05 | NCS | 15 tablets | — | AB1,AB2,AB3 | FDA listed | — |
| Levothyroxine Sodium .1 mg 31722-0288-01 | Camber | 100 tablets | — | AB4 | FDA listed | — |
| Levothyroxine Sodium 100 ug 50090-5654-00 | A-S | 30 tablets | — | AB1,AB2,AB3 | FDA listed | — |
| Levothyroxine sodium 100 ug 50090-6101-00 | A-S | 30 tablets | — | AB1,AB2,AB3,AB4 | FDA listed | — |
| Levothyroxine Sodium 100 ug 50090-6573-00 | A-S | 90 tablets | — | AB1,AB2,AB3 | FDA listed | — |
| Levothyroxine sodium 100 ug 50090-6579-00 | A-S | 90 tablets | — | AB1,AB2,AB3,AB4 | FDA listed | — |
| Levothyroxine Sodium .1 mg 50090-7336-00 | A-S | 30 tablets | — | AB1,AB2,AB3 | FDA listed | — |
| Levothyroxine Sodium .1 mg 50090-7337-00 | A-S | 90 tablets | — | AB1,AB2,AB3 | FDA listed | — |
| Levothyroxine Sodium 100 ug 50090-7648-00 | A-S | 30 tablets | — | AB1,AB2,AB3,AB4 | FDA listed | — |
| Levothyroxine Sodium 100 ug 50090-7649-00 | A-S | 90 tablets | — | AB1,AB2,AB3,AB4 | FDA listed | — |
| Levothyroxine Sodium 100 ug 51655-0544-52 | Northwind | 30 tablets | — | AB1,AB2,AB3 | FDA listed | — |
| Levothyroxine sodium 100 ug 51655-0742-52 | Northwind | 30 tablets | — | AB1,AB2,AB3,AB4 | FDA listed | — |
| Levothyroxine Sodium .1 mg 51655-0923-52 | Northwind | 30 tablets | — | AB1,AB2,AB3 | FDA listed | — |
| Levothyroxine Sodium .1 mg 55154-3561-00 | Cardinal | 10 tablets | — | AB1,AB2,AB3 | FDA listed | — |
| Levothyroxine Sodium 100 ug 55154-5381-00 | Cardinal | 10 tablets | — | AB1,AB2,AB3,AB4 | FDA listed | — |
| Levothyroxine Sodium .1 mg 67046-0569-03 | Coupler | 30 tablets | — | AB1,AB2,AB3 | FDA listed | — |
| Levothyroxine Sodium 100 ug 67046-1679-03 | Coupler | 30 tablets | — | AB1,AB2,AB3,AB4 | FDA listed | — |
| Levothyroxine sodium 100 ug 67296-2048-03 | Redpharm | 30 tablets | — | AB1,AB2,AB3,AB4 | FDA listed | — |
| Levothyroxine Sodium 100 ug 68071-2278-09 | NuCare | 90 tablets | — | AB1,AB2,AB3 | FDA listed | — |
| Levothyroxine Sodium .1 mg 68071-3717-09 | NuCare | 90 tablets | — | AB1,AB2,AB3 | FDA listed | — |
| levothyroxine sodium 100 ug 68071-5235-09 | NuCar | 90 tablets | — | AB1,AB2,AB3,AB4 | FDA listed | — |
| levothyroxine sodium 100 ug 68788-7729-01 | Preferred | 100 tablets | — | AB1,AB2,AB3,AB4 | FDA listed | — |
| Levothyroxine sodium 100 ug 68788-7929-01 | Preferred | 100 tablets | — | AB1,AB2,AB3,AB4 | FDA listed | — |
| Levothyroxine Sodium 100 ug 68788-8807-03 | Preferred | 30 tablets | — | AB1,AB2,AB3,AB4 | FDA listed | — |
| Levothyroxine sodium 100 ug 70518-4401-00 | REMEDYREPACK | 90 tablets | — | AB1,AB2,AB3,AB4 | FDA listed | — |
| Levothyroxine Sodium .1 mg 71205-0240-30 | Proficient | 30 tablets | — | AB1,AB2,AB3 | FDA listed | — |
| levothyroxine sodium 100 ug 71205-0351-30 | Proficient | 30 tablets | — | AB1,AB2,AB3,AB4 | FDA listed | — |
| Levothyroxine sodium 100 ug 71205-0642-30 | Proficient | 30 tablets | — | AB1,AB2,AB3,AB4 | FDA listed | — |
| levothyroxine sodium 100 ug 71335-1478-01 | Bryant | 100 tablets | — | AB1,AB2,AB3,AB4 | FDA listed | — |
| Levothyroxine Sodium 100 ug 71335-1814-01 | Bryant | 100 tablets | — | AB1,AB2,AB3 | FDA listed | — |
| Levothyroxine sodium 100 ug 71335-2138-01 | Bryant | 100 tablets | — | AB1,AB2,AB3,AB4 | FDA listed | — |
| levothyroxine sodium 100 ug 72162-1462-00 | Bryant | 1000 tablets | — | AB1,AB2,AB3,AB4 | FDA listed | — |
| Levothyroxine Sodium 100 ug 72189-0206-30 | DIRECT | 30 tablets | — | AB1,AB2,AB3,AB4 | FDA listed | — |
| Levothyroxine sodium 100 ug 72789-0297-30 | PD-Rx | 30 tablets | — | AB1,AB2,AB3,AB4 | FDA listed | — |
| Levothyroxine Sodium .1 mg 72865-0240-10 | XLCare | 1000 tablets | — | AB4 | FDA listed | — |
| Levothyroxine Sodium 100 ug 82804-0222-30 | Proficient | 30 tablets | — | AB1,AB2,AB3 | FDA listed | — |
| Levothyroxine Sodium .1 mg 82804-0290-30 | Proficient | 30 tablets | — | AB1,AB2,AB3 | FDA listed | — |
| Levothyroxine sodium 100 ug 87063-0087-00 | ASCLEMED | 1000 tablets | — | AB1,AB2,AB3,AB4 | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 68180-0969-01 | 100 TABLET in 1 BOTTLE (68180-969-01) | $0.0507 / ea | $5.07 | 2019-03-20 | Active |
| 68180-0969-02 | 500 TABLET in 1 BOTTLE (68180-969-02) | — | — | 2019-03-20 | Active |
| 68180-0969-03 | 1000 TABLET in 1 BOTTLE (68180-969-03) | $0.0507 / ea | $50.73 | 2019-03-20 | Active |
| 68180-0969-09 You're viewing this | 90 TABLET in 1 BOTTLE (68180-969-09) | $0.0507 / ea | $4.57 | 2019-03-20 | Active |
You're viewing the smallest of 4 pack sizes for this product.
This pack effectively ties for the lowest per-ea cost of the 3 priced pack sizes ($0.0507 NADAC).
This pack accounts for about 11% of this product's recent Medicaid fills; most go to the 1000 tablets pack. See all packs ↓
Pack size FAQ
What quantity is in NDC 68180-0969-09?
What is the difference between NDC 68180-0969-09 and NDC 68180-0969-01?
What NDC number is used to bill for this package of Levothyroxine Sodium .1 mg Tablet?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS Thyroid hormones, including levothyroxine sodium tablets, 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 )] .
WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS See full prescribing information for complete boxed warning. Thyroid hormones, including levothyroxine sodium tablet, 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 ▾
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 tablet is a L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: Hypothyroidism: As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.
( 1 ) Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. ( 1 ) Limitations of Use Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients. Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Administer once daily, preferably 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 ) Advise patients to stop biotin and biotin-containing supplements at least 2 days before assessing TSH and/or T4 levels. ( 2.2 ) Starting dose depends on a variety of factors, including age, body weight, cardiovascular status, and concomitant medications. 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 )
2.1Important Administration Instructions Administer levothyroxine sodium tablets as a single daily dose, on an empty stomach, one-half to one hour before breakfast. Administer levothyroxine sodium tablets at least 4 hours before or after drugs known to interfere with levothyroxine sodium tablets absorption [see Drug Interactions ( 7.1 )] . Evaluate the need for dosage adjustments when regularly administering within one hour of certain foods that may affect levothyroxine sodium tablets absorption [see Dosage and Administration ( 2.2 and 2.3 ), Drug Interactions ( 7.9 ), and Clinical Pharmacology ( 12.3 )] .
Administer levothyroxine sodium tablets to pediatric patients who cannot swallow intact tablets by crushing the tablet, suspending the freshly crushed tablet in a small amount (5 to 10 mL) of water and immediately administering the suspension by spoon or dropper. Ensure the patient ingests the full amount of the suspension. Do not store the suspension.
Do not administer in foods that decrease absorption of levothyroxine sodium tablets, such as soybean-based infant formula [see Drug Interactions ( 7.9 )] .
2.2Important Considerations for Dosing The dosage of levothyroxine sodium tablets 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 ), and Drug Interactions ( 7 )] . Dosing must be individualized to account for these factors and dosage adjustments made based on periodic assessment of the patient's clinical response and laboratory parameters [see Dosage and Administration ( 2.4 )] .
For adult patients with primary hypothyroidism, titrate until the patient is clinically euthyroid and the serum TSH returns to normal [see Dosage and Administration ( 2.3 )] . For secondary or tertiary hypothyroidism, serum TSH is not a reliable measure of levothyroxine sodium tablets dosage adequacy and should not be used to monitor therapy. Use the serum free-T4 level to titrate levothyroxine sodium tablets dosing until the patient is clinically euthyroid and the serum free-T4 level is restored to the upper half of the normal range [see Dosage and Administration ( 2.3 )].
Inquire whether patients are taking biotin or biotin-containing supplements. If so, advise them to stop biotin supplementation at least 2 days before assessing TSH and/or T4 levels [see Dosage and Administration ( 2.4 ) and Drug Interactions ( 7.10 )]. The peak therapeutic effect of a given dose of levothyroxine sodium tablets may not be attained for 4 to 6 weeks.
2.3Recommended Dosage and Titration Primary, Secondary, and Tertiary Hypothyroidism in Adults The recommended starting daily dosage of levothyroxine sodium tablets in adults with primary, secondary, or tertiary hypothyroidism is based on age and comorbid cardiac conditions, as described in Table 1. For patients at risk of atrial…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Levothyroxine sodium tablets USP are round, colored, scored and debossed with following debossing details on one side and break-line on other side. They are available as follows (Table 4) Table 4: Levothyroxine Sodium Tablet Strengths and Identifying Features Tablet Strength Tablet Color/Shape Debossing Details 25 mcg Peach/Round L15 50 mcg White/Round L16 75 mcg Violet/Round L17 88 mcg Olive/Round L19 100 mcg Yellow/Round L20 112 mcg Rose/Round L21 125 mcg Tan/Round L22 137 mcg Turquoise/Round L23 150 mcg Blue/Round L24 175 mcg Lilac/Round L25 200 mcg Pink/Round L26 300 mcg Green/Round L27 Tablets: 25, 50, 75, 88, 100, 112, 125, 137, 150, 175, 200, and 300 mcg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Levothyroxine sodium tablets are contraindicated in patients with uncorrected adrenal insufficiency [see Warnings and Precautions ( 5.4 )] . Uncorrected adrenal insufficiency. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Serious risks related to overtreatment or undertreatment with levothyroxine sodium tablet : Titrate the dose of levothyroxine sodium tablet carefully and monitor response to titration. ( 5.1 ). Cardiac adverse reactions in the elderly and in patients with underlying cardiovascular disease: Initiate levothyroxine sodium tablet at less than the full replacement dose because of the increased risk of cardiac adverse reactions, including atrial fibrillation.
( 2.3 , 5.2 , 8.5 ) Myxedema coma: Do not use oral thyroid hormone drug products to treat myxedema coma. ( 5.3 ) Acute adrenal crisis in patients with concomitant adrenal insufficiency: Treat with replacement glucocorticoids prior to initiation of levothyroxine sodium tablet treatment. ( 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 )
5.1Serious Risks Related to Overtreatment or Undertreatment with Levothyroxine sodium tablets Levothyroxine sodium tablet has a narrow therapeutic index. Overtreatment or undertreatment with Levothyroxine sodium tablets may have negative effects on growth and development, cardiovascular function, bone metabolism, reproductive function, cognitive function, gastrointestinal function, and glucose and lipid metabolism in adult or pediatric patients. In pediatric patients with congenital and acquired hypothyroidism, undertreatment may adversely affect cognitive development and linear growth, and overtreatment is associated with craniosynostosis and acceleration of bone age [see Use in Specific Populations ( 8.4 )] .
Titrate the dose of Levothyroxine sodium tablets carefully and monitor response to titration to avoid these effects [see Dosage and Administration ( 2.4 )] . Consider the potential for food or drug interactions and adjust the administration or dosage of Levothyroxine sodium tablets as needed [see Dosage and Administration ( 2.1 ), Drug Interactions ( 7.1 ), and Clinical Pharmacology ( 12.3 )] .
5.2Cardiac Adverse Reactions in the Elderly and in Patients with Underlying Cardiovascular Disease Over-treatment 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 levothyroxine sodium tablets 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 ) and Use in Specific Populations ( 8.5 )] .
Monitor for cardiac arrhythmias during surgical procedures in patients with coronary artery disease receiving suppressive levothyroxine sodium tablets therapy. Monitor patients receiving concomitant levothyroxine sodium tablets and sympathomimetic agents for signs and symptoms of coronary insufficiency. If cardiac symptoms develop or worsen, reduce the levothyroxine sodium tablets dose or withhold for one week and restart at a lower dose.
5.3Myxedema 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.
5.4Acute Adrenal Crisis in Patients with Concomitant Adrenal Insufficiency Thyroid hormone increases metabolic clearance of glucocorticoids. Initiation of thyroid hormone therapy p…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Adverse reactions associated with levothyroxine sodium tablets therapy are primarily those of hyperthyroidism due to therapeutic overdosage [see Warnings and Precautions ( 5 ) and 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, muscle weakness, muscle spasm Cardiovascular: palpitations, tachycardia, arrhythmias, increased pulse and blood pressure, heart failure, angina, myocardial infarction, cardiac arrest Respiratory: dyspnea Gastrointestinal: diarrhea, vomiting, abdominal cramps, 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 the institution of levothyroxine therapy.
Adverse Reactions in Pediatric Patients Pseudotumor cerebri and slipped capital femoral epiphysis have been reported in pediatric patients receiving levothyroxine therapy. Overtreatment may result in craniosynostosis in infants who have not undergone complete closure of the fontanelles, and in premature closure of the epiphyses in pediatric patients still experiencing growth with resultant compromised adult height. Hypersensitivity Reactions Hypersensitivity reactions to inactive ingredients have occurred in patients treated with thyroid hormone products.
These include urticaria, pruritus, skin rash, flushing, angioedema, various gastrointestinal symptoms (abdominal pain, nausea, vomiting and diarrhea), fever, arthralgia, serum sickness, and wheezing. Hypersensitivity to levothyroxine itself is not known to occur. Adverse reactions associated with levothyroxine sodium tablets therapy 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 Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🔄 Drug Interactions ▾
7 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 levothyroxine sodium tablets. ( 7 )
7.1Drugs Known to Affect Thyroid Hormone Pharmacokinetics Many drugs can exert effects on 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 tablets (Tables 5 to 8). Table 5. Drugs That May Decrease T4 Absorption (Hypothyroidism) Potential impact: Concurrent use may reduce the efficacy of levothyroxine sodium tablets by binding and delaying or preventing absorption, potentially resulting in hypothyroidism.
Drug or Drug Class Effect Phosphate Binders (e.g., calcium carbonate, ferrous sulfate, sevelamer, lanthanum) Phosphate binders may bind to levothyroxine. Administer levothyroxine sodium tablets at least 4 hours apart from these agents. Orlistat Monitor patients treated concomitantly with orlistat and levothyroxine sodium tablets for changes in thyroid function.
Bile Acid Sequestrants (e.g., colesevelam, cholestyramine, colestipol) Ion Exchange Resins (e.g., Kayexalate) Bile acid sequestrants and ion exchange resins are known to decrease levothyroxine absorption. Administer levothyroxine sodium tablets at least 4 hours prior to these drugs or monitor TSH levels. Proton Pump Inhibitors Sucralfate Antacids (e.g., 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. Table 6.
Drugs That May Alter T4 and Triiodothyronine (T3) Serum Transport Without Affecting Free Thyroxine (FT4) Concentration (Euthyroidism) 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 levothyroxine sodium tablets 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 increase 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. Table 7.
Drugs That May Alter Hepatic Metabolism of T4 (Hypothyroidism) Potential impact: Stimulation of hepatic microsomal drug-metabolizing enzyme activity may cause increased hepatic degradation of levothyroxine, resulting in increased levothyroxine sodium tablets requirements. Drug or Drug Class Effect Phenobarbital Rifampin Phenobarbital has been shown to reduce the response to th…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy may require the use of higher doses of levothyroxine sodium tablets. ( 2.3 , 8.1 )
8.1Pregnancy Risk Summary The clinical experience, including data from postmarketing studies, in pregnant women treated with oral levothyroxine to maintain euthyroid state have not reported increased rates of major birth defects, miscarriages, or other adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with untreated hypothyroidism in pregnancy. Since TSH levels may increase during pregnancy, TSH should be monitored and levothyroxine sodium tablets dosage adjusted during pregnancy (see Clinical Considerations) .
Animal reproductive studies have not been conducted with levothyroxine sodium. Levothyroxine sodium tablets should not be discontinued during pregnancy and hypothyroidism diagnosed during pregnancy should be promptly treated. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Maternal hypothyroidism during pregnancy is associated with a higher rate of complications, including spontaneous abortion, gestational hypertension, pre-eclampsia, stillbirth, and premature delivery.
Untreated maternal hypothyroidism may have an adverse effect on fetal neurocognitive development. Dose Adjustments During Pregnancy and the Postpartum Period Pregnancy may increase levothyroxine sodium tablets requirements. Serum TSH levels should be monitored and the levothyroxine sodium tablets dosage adjusted during pregnancy.
Since postpartum TSH levels are similar to preconception values, the levothyroxine sodium tablets dosage should return to the pre-pregnancy dose immediately after delivery [see Dosage and Administration ( 2.3 )] .
8.2Lactation Risk Summary Published studies report that levothyroxine is present in human milk following the administration of oral levothyroxine. No adverse effects on the breastfed infant have been reported and there is no information on the effects of levothyroxine on milk production. Adequate levothyroxine treatment during lactation may normalize milk production in hypothyroid lactating mothers with low milk supply.
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for levothyroxine sodium tablets and any potential adverse effects on the breastfed infant from levothyroxine sodium tablets or from the underlying maternal condition.
8.4Pediatric Use Levothyroxine Sodium Tablets is indicated in patients from birth to less than 17 years of age: As a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Rapid restoration of normal serum T4 concentrations is essential for preventing the adverse effects of congenital hypothyroidism on cognitive development as well as on overall physical growth and maturation.
Therefore, initiate levothyroxine sodium tablets therapy immediately upon diagnosis. Levothyroxine is generally continued for life in these patients. [see Warnings and Precautions ( 5.1 )] . Closely monitor infants during the first 2 weeks of levothyroxine sodium tablets therapy for cardiac overload and arrhythmias.
8.5Geriatric Use Because of the increased prevalence of cardiovascular disease among the elderly, initiate levothyroxine sodium tablets at less than the full replacement dose [see Dosage and Administration ( 2.3 ) and Warnings and Precautions ( 5.2 )] . Atrial arrhythmias can oc…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary The clinical experience, including data from postmarketing studies, in pregnant women treated with oral levothyroxine to maintain euthyroid state have not reported increased rates of major birth defects, miscarriages, or other adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with untreated hypothyroidism in pregnancy. Since TSH levels may increase during pregnancy, TSH should be monitored and levothyroxine sodium tablets dosage adjusted during pregnancy (see Clinical Considerations) .
Animal reproductive studies have not been conducted with levothyroxine sodium. Levothyroxine sodium tablets should not be discontinued during pregnancy and hypothyroidism diagnosed during pregnancy should be promptly treated. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Maternal hypothyroidism during pregnancy is associated with a higher rate of complications, including spontaneous abortion, gestational hypertension, pre-eclampsia, stillbirth, and premature delivery.
Untreated maternal hypothyroidism may have an adverse effect on fetal neurocognitive development. Dose Adjustments During Pregnancy and the Postpartum Period Pregnancy may increase levothyroxine sodium tablets requirements. Serum TSH levels should be monitored and the levothyroxine sodium tablets dosage adjusted during pregnancy.
Since postpartum TSH levels are similar to preconception values, the levothyroxine sodium tablets dosage should return to the pre-pregnancy dose immediately after delivery [see Dosage and Administration ( 2.3 )] .
🧒 Pediatric Use ▾
8.4Pediatric Use Levothyroxine Sodium Tablets is indicated in patients from birth to less than 17 years of age: As a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Rapid restoration of normal serum T4 concentrations is essential for preventing the adverse effects of congenital hypothyroidism on cognitive development as well as on overall physical growth and maturation.
Therefore, initiate levothyroxine sodium tablets therapy immediately upon diagnosis. Levothyroxine is generally continued for life in these patients. [see Warnings and Precautions ( 5.1 )] . Closely monitor infants during the first 2 weeks of levothyroxine sodium tablets therapy for cardiac overload and arrhythmias.
🧓 Geriatric Use ▾
8.5Geriatric Use Because of the increased prevalence of cardiovascular disease among the elderly, initiate levothyroxine sodium tablets at less than the full replacement dose [see Dosage and Administration ( 2.3 ) and Warnings and Precautions ( 5.2 )] . Atrial arrhythmias can occur in elderly patients. Atrial fibrillation is the most common of the arrhythmias observed with levothyroxine overtreatment in the elderly.
🆘 Overdosage ▾
10 OVERDOSAGE The signs and symptoms of overdosage 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.
Seizures occurred in a 3-year -old child ingesting 3.6 mg of levothyroxine. Symptoms may not necessarily be evident or may not appear until several days after ingestion of levothyroxine sodium. Reduce the levothyroxine sodium tablets dosage 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism 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.
12.2Pharmacodynamics 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.
12.3Pharmacokinetics Absorption Absorption of orally administered T4 from the gastrointestinal tract ranges from 40% to 80%. The majority of the levothyroxine sodium tablets dose is absorbed from the jejunum and upper ileum. The relative bioavailability of levothyroxine sodium tablets, compared to an equal nominal dose of oral levothyroxine sodium solution, is approximately 93%.
T4 absorption is increased by fasting, and decreased in malabsorption syndromes and by certain foods such as soybeans. Dietary fiber decreases bioavailability of T4. Absorption may also decrease with age.
In addition, many drugs and foods affect T4 absorption [see Drug Interactions ( 7 )] . Distribution Circulating thyroid hormones are greater than 99% bound to plasma proteins, including thyroxine-binding globulin (TBG), thyroxine-binding prealbumin (TBPA), and albumin (TBA), whose capacities and affinities vary for each hormone. The higher affinity of both TBG and TBPA for T4 partially explains the higher serum levels, slower metabolic clearance, and longer half-life of T4 compared to T3.
Protein-bound thyroid hormones exist in reverse equilibrium with small amounts of free hormone. Only unbound hormone is metabolically active. Many drugs and physiologic conditions affect the binding of thyroid hormones to serum proteins [see Drug Interactions ( 7 )] .
Thyroid hormones do not readily cross the placental barrier [see Use in Specific Populations ( 8.1 )] . Elimination Metabolism T4 is slowly eliminated (see Table 10). The major pathway of thyroid hormone metabolism is through sequential deiodination.
Approximately 80% of circulating T3 is derived from peripheral T4 by monodeiodination. The liver is the major site of degradation for both T4 and T3, with T4 deiodination also occurring at a number of additional sites, including the kidney and other tissues. Approximately 80% of the daily dose of T4 is deiodinated to yield equal amounts of T3 and reverse T3 (rT3).
T3 and rT3 are further deiodinated to diiodothyronine. Thyroid hormones are also metabolized via conjugation with glucuronides and sulfates and excreted directly into the bile and gut where they undergo enterohepatic recirculation. Excretion Thyroid hormones are primarily eliminated by the kidneys.
A portion of the conjugated hormone reaches the colon unchanged and is eliminated in the feces. Approximately 20% of T4 is eliminated in the stool. Urinary excretion of T4 decreases with age.
Table 10. Pharmacokinetic Parameters of Thyroid Hormones in Euthyroid Patients a. Includes TBG, TBPA, and TBA b.
3 to 4 days in hyperthyroidism, 9 to 10 days in hypothyroidism Hormone Ratio in Thyroglobulin Biologic Potency t 1/2 (days) Protein Binding (%) a Levothyroxine (T4) 10 to 20 1 6 to 7 b
99.96Liothyronine (T3) 1 4 ≤ 2 99.5
🧬 Mechanism of Action ▾
12.1Mechanism 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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Levothyroxine sodium tablets USP are round, colored, scored and debossed with following debossing details on one side and break-line on other side. They are supplied as follows: Strength (mcg) Color/Shape Debossing Details NDC# for bottles of 90 NDC # for bottles of 100 NDC # for bottles of 1000 25 Peach/Round L15 68180-965-09 68180-965-01 68180-965-03 50 White/Round L16 68180-966-09 68180-966-01 68180-966-03 75 Violet/Round L17 68180-967-09 68180-967-01 68180-967-03 88 Olive/Round L19 68180-968-09 68180-968-01 68180-968-03 100 Yellow/Round L20 68180-969-09 68180-969-01 68180-969-03 112 Rose/Round L21 68180-970-09 68180-970-01 68180-970-03 125 Tan/Round L22 68180-971-09 68180-971-01 68180-971-03 137 Turquoise/Round L23 68180-972-09 68180-972-01 68180-972-03 150 Blue/Round L24 68180-973-09 68180-973-01 68180-973-03 175 Lilac/Round L25 68180-974-09 68180-974-01 68180-974-03 200 Pink/Round L26 68180-975-09 68180-975-01 68180-975-03 300 Green/Round L27 68180-976-09 68180-976-01 68180-976-03 Storage and Handling Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86° F) [see USP Controlled Room Temperature].
Levothyroxine sodium tablets USP should be protected from light and moisture.
📋 Description ▾
11 DESCRIPTION Levothyroxine sodium tablets USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3',5,5' tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15 H 10 I 4 N NaO 4 •H 2 O, molecular weight of 798.85 (anhydrous), and structural formula as shown: Levothyroxine sodium tablets USP 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, 200 mcg, and 300 mcg.
Each levothyroxine sodium tablets USP contains the inactive ingredients corn starch, croscarmellose sodium, magnesium stearate, mannitol and sodium bicarbonate. Table 9 provides a listing of the color additives by tablet strength: Table 9. Levothyroxine Sodium Tablets USP Color Additives Levothyroxine sodium tablet USP meets USP Dissolution Test 2.
Strength (mcg) Color additive(s) 25 FD&C Yellow No. 6 Aluminum Lake* 50 FD&C Blue 1 Aluminum Lake 75 FD&C Red No. 40 Aluminum Lake, FD&C Blue No.
2 Aluminum Lake 88 FD&C Yellow No. 6 Aluminum Lake*, FD&C Blue No. 1 Aluminum Lake, D&C Yellow No.
10 Aluminum Lake 100 FD&C Yellow No. 6 Aluminum Lake*, D&C Yellow No. 10 Aluminum Lake 112 D&C Red No.
27 Aluminum Lake 125 FD&C Yellow No. 6 Aluminum Lake*, FD&C Blue No. 1 Aluminum Lake, FD&C Red No.
40 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake 137 FD&C Blue No. 1 Aluminum Lake 150 FD&C Blue No.
2 Aluminum Lake 175 FD&C Blue No. 1 Aluminum Lake, D&C Red No. 27 Aluminum Lake 200 FD&C Red No.
40 Aluminum Lake 300 FD&C Yellow No. 6 Aluminum Lake*, FD&C Blue No. 1 Aluminum Lake, D&C Yellow No.
10 Aluminum Lake *Note – FD&C Yellow No. 6 Aluminum Lake is peach in color. image-1
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Inform the patient of the following information to aid in the safe and effective use of levothyroxine sodium tablets : Dosing and Administration Instruct patients to take levothyroxine sodium tablets only as directed by their healthcare provider. Instruct patients to take levothyroxine sodium tablets as a single dose, preferably on an empty stomach, one-half to one hour before breakfast. Inform patients that agents such as iron and calcium supplements and antacids can decrease the absorption of levothyroxine.
Instruct patients not to take levothyroxine sodium tablets within 4 hours of these agents. Instruct patients to notify their healthcare provider if they are pregnant or breastfeeding or are thinking of becoming pregnant while taking levothyroxine sodium tablets. Important Information Inform patients that it may take several weeks before they notice an improvement in symptoms.
Inform patients that the levothyroxine in levothyroxine sodium tablet is intended to replace a hormone that is normally produced by the thyroid gland. Generally, replacement therapy is to be taken for life. Inform patients that levothyroxine sodium tablets should not be used as a primary or adjunctive therapy in a weight control program.
Instruct patients to notify their healthcare provider if they are taking any other medications, including prescription and over-the-counter preparations. Instruct patients to discontinue biotin or any biotin-containing supplements for at least 2 days before thyroid function testing is conducted. Instruct patients to notify their physician of any other medical conditions they may have, particularly heart disease, diabetes, clotting disorders, and adrenal or pituitary gland problems, as the dose of medications used to control these other conditions may need to be adjusted while they are taking levothyroxine sodium tablets.
If they have diabetes, instruct patients to monitor their blood and/or urinary glucose levels as directed by their physician and immediately report any changes to their physician. If patients are taking anticoagulants, their clotting status should be checked frequently. Instruct patients to notify their physician or dentist that they are taking levothyroxine sodium tablets prior to any surgery.
Adverse Reactions Instruct patients to notify their healthcare provider if they experience any of the following symptoms: rapid or irregular heartbeat, chest pain, shortness of breath, leg cramps, headache, nervousness, irritability, sleeplessness, tremors, change in appetite, weight gain or loss, vomiting, diarrhea, excessive sweating, heat intolerance, fever, changes in menstrual periods, hives or skin rash, or any other unusual medical event. Inform patients that partial hair loss may occur rarely during the first few months of levothyroxine sodium tablets therapy, but this is usually temporary.
Manufactured for: Lupin Pharmaceuticals, Inc. Naples, FL 34108 United States Manufactured by: Lupin Limited Pithampur (M.P.) - 454 775 INDIA Revised: August 2024 ID#: 276412 trade mark