NDC 82347-0020 Levothyroxine Sodium
Capsule Oral

Product Information

What is NDC 82347-0020?

The NDC code 82347-0020 is assigned by the FDA to the UNFINISHED product Levothyroxine Sodium which is a human prescription drug product labeled by Yaral Pharma Inc.. The product's dosage form is capsule and is administered via oral form. The product is distributed in a single package with assigned NDC code 82347-0020-4 3 blister pack in 1 carton / 10 capsule in 1 blister pack. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code82347-0020
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		Levothyroxine Sodium
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.		Levothyroxine Sodium
Substance Name What is the Substance Name?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.		Levothyroxine Sodium
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.		Human Prescription Drug
Dosage FormCapsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Yaral Pharma Inc.
Labeler Code82347
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.		NDA021924
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.		NDA AUTHORIZED GENERIC - A product marketed as a “generic” drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		03-01-2023
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.		12-31-2024
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I". 		N
Unfinished Product What is an Unfinished Product?
Not Available		Yes
NDC Code Structure

What are the uses for Levothyroxine Sodium?


Product Characteristics

Color(s)BROWN (C48332)
ShapeOVAL (C48345)
Size(s)7 MM
Imprint(s)A
E
G
H
Score1

Product Packages

NDC Code 82347-0020-4

Package Description: 3 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Product Details

What are Levothyroxine Sodium Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • LEVOTHYROXINE SODIUM 75 ug/1 - The major hormone derived from the thyroid gland. Thyroxine is synthesized via the iodination of tyrosines (MONOIODOTYROSINE) and the coupling of iodotyrosines (DIIODOTYROSINE) in the THYROGLOBULIN. Thyroxine is released from thyroglobulin by proteolysis and secreted into the blood. Thyroxine is peripherally deiodinated to form TRIIODOTHYRONINE which exerts a broad spectrum of stimulatory effects on cell metabolism.

Levothyroxine Sodium Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Levothyroxine Sodium Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Levothyroxine Sodium Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Warning: Not For Treatment Of Obesity Or For Weight Loss



  • Thyroid hormones, including Levothyroxine Sodium capsules, 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)].

2.1 General Administration Information



Administer Levothyroxine Sodium capsules as a single daily oral dose, on an empty stomach, one-half to one hour before breakfast.

Administer Levothyroxine Sodium capsules at least 4 hours before or after drugs known to interfere with Levothyroxine Sodium capsules absorption [see Drug Interactions (7.1)]

Evaluate the need for dose adjustments when regularly administering within an hour of certain foods that may affect Levothyroxine Sodium capsules absorption [see Drug Interactions (7.9) and Clinical Pharmacology (12.3)].

Swallow Levothyroxine Sodium capsules whole, do not cut, crush, or chew.


2.2 General Principles Of Dosing



The dose of Levothyroxine Sodium capsules 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 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 Levothyroxine Sodium capsules may not be attained for 4 to 6 weeks.


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 Levothyroxine Sodium capsules may be evidence of inadequate absorption, poor compliance, drug interactions, or a combination of these factors.


3 Dosage Forms And Strengths



Levothyroxine Sodium capsules are amber-colored, round/biconvex capsules, imprinted with a dosage strength specific letter on one side and containing a viscous amber-colored liquid and are available as follows:

Strength (mcg)Imprint Code
13A
25E
50G
75H
88J
100K
112M
125N
137P
150S
175U
200Y

4 Contraindications



Levothyroxine Sodium capsules are contraindicated in patients with uncorrected adrenal insufficiency [see Warnings and Precautions (5.3)].


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 Levothyroxine Sodium capsules 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 capsules therapy. Monitor patients receiving concomitant Levothyroxine Sodium capsules and sympathomimetic agents for signs and symptoms of coronary insufficiency . If cardiac symptoms develop or worsen, reduce the Levothyroxine Sodium capsules dose or withhold it 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 precipitate an acute adrenal crisis in patient with adrenal insufficiency. Treat patients with adrenal insufficiency with replacement glucocorticoids prior to initiating treatment with Levothyroxine Sodium capsules [see Contraindications (4)].


5.4 Prevention Of Hyperthyroidism Or Incomplete Treatment Of Hypothyroidism



Levothyroxine Sodium capsules have a narrow therapeutic index. Over- or under-treatment with Levothyroxine Sodium capsules 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 Levothyroxine Sodium capsules 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 Levothyroxine Sodium capsules and adjust the dose as necessary [see Drug Interactions (7) and 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 thyroid hormone therapy [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 Levothyroxine Sodium capsules that achieves the desired clinical and biochemical response to mitigate against this risk.


6 Adverse Reactions



Adverse reactions associated with Levothyroxine Sodium capsules 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 (GI): 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.


7.1 Drugs Known To Affect Thyroid Hormone Pharmacokinetics



Many drugs can exert effects thyroid hormone pharmacokinetics (e.g., absorption, synthesis, secretion, catabolism, protein binding, and target tissue response) and may alter the therapeutic response to levothyroxine sodium capsules (see Tables 2 to 5 below).

Table 2: Drugs That May Decrease T4 Absorption (Hypothyroidism)
Potential impact: Concurrent use may reduce the efficacy of levothyroxine sodium capsules by binding and delaying or preventing absorption, potentially resulting in hypothyroidism
Drug or Drug ClassEffect
Calcium Carbonate
Ferrous Sulfate 		Calcium carbonate may form an insoluble chelate with levothyroxine, and ferrous sulfate likely forms a ferric-thyroxine complex. Administer levothyroxine sodium capsules at least 4 hours apart from these agents.
OrlistatMonitor patients treated concomitantly with orlistat and levothyroxine sodium capsules 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 levothyroxine sodium capsules 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
Table 3: Drugs That May Alter T4 and Triiodothyronine (T3) Serum Transport Without Affecting Free Thyroxine (FT4) Concentration (Euthyroidism)
Drug or Drug ClassEffect
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 capsules 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.
Table 4: 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 capsules requirements.
Drug or Drug ClassEffect
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.
Table 5: Drugs That May Decrease Conversion of T4 to T3
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 ClassEffect
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 levothyroxine sodium capsules therapy in patients with diabetes mellitus may worsen glycemic control and result in increased antidiabetic agent or insulin requirements. Careful monitor glycemic control, especially when thyroid therapy is started, changed, or discontinued [see Warnings and Precautions (5.5)] .


7.3 Oral Anticoagulants



Levothyroxine sodium capsules increase 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 capsules dose is increased. Closely monitor coagulation tests to permit appropriate and timely dosage adjustments.


7.4 Digitalis Glycosides



Levothyroxine sodium capsules 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 levothyroxine sodium capsules 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. Levothyroxine sodium capsules may accelerate the onset of action of tricyclics. Administration of sertraline in patients stabilized on levothyroxine sodium capsules may result in increased levothyroxine sodium capsules requirements.


7.6 Ketamine



Concurrent use of ketamine and levothyroxine sodium capsules may produce marked hypertension and tachycardia. Closely monitor blood pressure and heart rate in these patients.


7.7 Sympathomimetics



Concurrent use of sympathomimetics and levothyroxine sodium capsules 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 levothyroxine sodium capsules 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 levothyroxine sodium capsules from the GI 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.


8.4 Pediatric Use



Levothyroxine Sodium capsules are indicated for use in pediatric patients 6 years and older. The initial dose of Levothyroxine Sodium capsules 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 Levothyroxine Sodium capsules administration for a trial period. Obtain serum T4 and TSH levels at the end of the trial period, and use laboratory test results and clinical assessments to guide diagnosis and treatment, if warranted.


8.5 Geriatric Use



Because of the increased prevalence of cardiovascular disease among the elderly, initiate Levothyroxine Sodium capsules therapy 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) 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 capsules 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 Description



Levothyroxine Sodium capsules for oral use contain synthetic L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T 4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4NNaO 4 ∙ x H 2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:

Chemical Structure - levothyroxine 01

Chemical Structure - levothyroxine 01

Levothyroxine Sodium capsules are amber-colored, round/biconvex capsules containing a viscous amber-colored liquid.

The inactive ingredients in Levothyroxine Sodium capsules are gelatin, glycerin and water.


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.


13.1 Carcinogenesis, Mutagenesis, Impairment Of Fertility



Animal studies have not been performed to evaluate the carcinogenic potential, mutagenic potential or effects on fertility of levothyroxine sodium.


16 How Supplied/Storage And Handling



Store at 25°C (77°F); excursions permitted to 15°-30°C (59-86°F) [see USP Controlled Room Temperature]. Levothyroxine Sodium capsules should be protected from heat, light and moisture.

Do not separate the individual cavities containing the drug from the intact blister as important information may be lost (i.e., manufacturer/distributor names, distributor contact phone number, lot number, and expiration date), and do not remove the individual capsules from blister packaging until ready to use.


16.1 How Supplied



Levothyroxine Sodium capsules are amber-colored, round/biconvex capsules, imprinted with a dosage strength specific letter on one side and containing a viscous amber-colored liquid. They are supplied as follows:

Table 7: Levothyroxine Sodium Capsules Packaging Description - Boxes of 30 capsules, consisting of 3 blisters with 10 capsules each
Strength (mcg)Color

Shown on box and blister packing, not on individual capsules.

Imprint CodeNDC
13GreenA82347-0005-4
25OrangeE82347-0010-4
50WhiteG82347-0015-4
75PurpleH82347-0020-4
88OliveJ82347-0025-4
100YellowK82347-0030-4
112RoseM82347-0035-4
125BrownN82347-0040-4
137TurquoiseP82347-0045-4
150BlueS82347-0050-4
175LilacU82347-0055-4
200PinkY82347-0060-4

The dosage strength on each box is clearly identified in several locations, and is associated with a distinct color. The color of the circles on the blister is the same color as on the box. Each blister pack contains 10 capsules placed in individual cavities labeled with the dosage strength and the product name (Levothyroxine Sodium capsules).


17 Patient Counseling Information



Advise the patient and/or the caregiver to read the FDA-approved patient labeling (Patient Information Sheet).


* Please review the disclaimer below.