Levothyroxine Sodium

Manufacturer: Fresenius Kabi USA, LLC
Effective date: 2020-12-04
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:34:06

Label at a glance#

ProductLevothyroxine Sodium

Active ingredientLevothyroxine sodium

Label structure16 sections

Boxed warning

Thyroid hormones, including Levothyroxine Sodium Injection, should not be used for the treatment of obesity or for weight loss. Larger doses may produce serious or even life threatening manifestations of toxicity. ( 6 , 10 )

Indications and uses

Levothyroxine Sodium Injection is indicated for the treatment of myxedema coma. Limitations of Use: Not recommended as a substitute for oral levothyroxine sodium because the relative bioavailability of Levothyroxine Sodium Injection to oral levothyroxine sodium has not been established and there is a risk of inaccurate dose conversion.

Dosage and administration

Consider the age, general physical condition, cardiac risk factors, and clinical severity of myxedema and duration of myxedema symptoms when determining the starting and maintenance dosages of Levothyroxine Sodium Injection. Start with lower doses in elderly patients and in patients with underlying cardiovascular disease [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.5 )]. The recommende...

Storage and handling

Levothyroxine Sodium Injection is a clear, colorless solution available as follows: NDC Total Strength per Total Volume Concentration 63323-885-12 100 mcg per 5 mL 20 mcg per mL Protect from light in the original vial in a carton and store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. The unopened vial may be stored for up to 24 hours exposed to indoor lighting outside of the carton. The drug...

Contacts and useful links#

PhoneLabel contact1-800-551-7176

PhoneFDA MedWatch1-800-FDA-1088

Websitewww.fda.gov

www.fda.gov/medwatch

Websitewww.fresenius-kabi.com

www.fresenius-kabi.com/us

Label contents#

Full prescribing information#

WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS

BOXED WARNING SECTION

Thyroid hormones, including Levothyroxine Sodium Injection, should not be used for the treatment of obesity or for weight loss.

Larger doses may produce serious or even life threatening manifestations of toxicity. (6,10)

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Levothyroxine Sodium Injection is indicated for the treatment of myxedema coma.

SPL UNCLASSIFIED SECTION

Limitations of Use:

Not recommended as a substitute for oral levothyroxine sodium because the relative bioavailability of Levothyroxine Sodium Injection to oral levothyroxine sodium has not been established and there is a risk of inaccurate dose conversion.

2 DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

2.1 Dosage

SPL UNCLASSIFIED SECTION

Consider the age, general physical condition, cardiac risk factors, and clinical severity of myxedema and duration of myxedema symptoms when determining the starting and maintenance dosages of Levothyroxine Sodium Injection.
Start with lower doses in elderly patients and in patients with underlying cardiovascular disease [see Warnings and Precautions (5.1) and Use in Specific Populations (8.5)].
The recommended loading dose of Levothyroxine Sodium Injection is 300 mcg to 500 mcg administered intravenously.
The recommended maintenance dose of Levothyroxine Sodium Injection is 50 mcg to 100 mcg administered intravenously daily until the patient can tolerate oral therapy.

2.2 Administration Instructions

SPL UNCLASSIFIED SECTION

Administer Levothyroxine Sodium Injection as an intravenous injection at a rate not to exceed 100 mcg per minute.
Do not add Levothyroxine Sodium Injection to intravenous fluids.
Inspect Levothyroxine Sodium Injection visually prior to injection. It should appear clear and colorless, solution free of visible particulates. Do not use if particulate matter or coloration is seen.
Discard any unused portion.

3 DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

Levothyroxine Sodium Injection is clear, colorless solution supplied as:

100 mcg per 5 mL (20 mcg per mL) single-dose vial

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Uncorrected adrenal insufficiency [see Warnings and Precautions (5.2)]

5 WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

5.1 Cardiac Adverse Reactions in the Elderly and in Patients with Underlying Cardiovascular Disease

SPL UNCLASSIFIED SECTION

Overtreatment with Levothyroxine Sodium Injection may cause arrhythmias, tachycardia, myocardial ischemia and infarction, or worsening of congestive heart failure and death, particularly in patients with cardiovascular disease and in elderly patients. Start with lower doses in elderly patients and in patients with underlying cardiovascular disease and monitor patients after administration of Levothyroxine Sodium Injection for cardiac adverse reactions.

5.2 Acute Adrenal Crisis in Patients with Concomitant Adrenal Insufficiency

SPL UNCLASSIFIED SECTION

Chronic autoimmune thyroiditis, which can lead to myxedema coma, may occur in association with other autoimmune disorders such as 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 [see Contraindications (4)]. Treat patients with adrenal insufficiency with replacement glucocorticoids prior to initiating treatment with Levothyroxine Sodium Injection.

5.3 Worsening of Diabetic Control

SPL UNCLASSIFIED SECTION

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 [see Drug Interactions (7.2)].

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

Adverse reactions associated with levothyroxine 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, 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: flushing, rash

Seizures have been reported rarely with the institution of levothyroxine therapy.

SPL UNCLASSIFIED SECTION

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.

7 DRUG INTERACTIONS

DRUG INTERACTIONS SECTION

7.1 Drugs Known to Affect Thyroid Hormone Pharmacokinetics

SPL UNCLASSIFIED SECTION

Many drugs affect thyroid hormone pharmacokinetics and metabolism (e.g., synthesis, secretion, catabolism, protein binding, and target tissue response) and may alter the therapeutic response to Levothyroxine Sodium Injection (see Tables 1-3).

Table 1: Drugs That May Alter T₄ and Triiodothyronine (T₃) Serum Transport Without Effecting 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 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 2: 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 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.

Table 3: 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 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 slightly, TSH levels remain normal, and patients are clinically euthyroid. It should be noted that 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 above).
Other drugs: Amiodarone	Amiodarone inhibits peripheral conversion of levothyroxine (T4) to triiodothyronine (T3) and may cause isolated biochemical changes (increase in serum free-T4, and decreased or normal free-T3) in clinically euthyroid patients.

7.2 Antidiabetic Therapy

SPL UNCLASSIFIED SECTION

Addition of levothyroxine to antidiabetic or insulin therapy may result in increased antidiabetic agent or insulin requirements. Careful monitoring of glycemic control is recommended.

7.3 Oral Anticoagulants

SPL UNCLASSIFIED SECTION

Levothyroxine increases the response to oral anticoagulant therapy. Therefore, a decrease in the dose of anticoagulant may be warranted with correction of the hypothyroid state. Closely monitor coagulation tests to permit appropriate and timely dosage adjustments.

7.4 Digitalis Glycosides

SPL UNCLASSIFIED SECTION

Levothyroxine may reduce the therapeutic effects of digitalis glycosides. Serum digitalis glycoside levels may be decreased when a hypothyroid patient becomes euthyroid, necessitating an increase in the dose of digitalis glycosides.

7.5 Antidepressant Therapy

SPL UNCLASSIFIED SECTION

Concurrent use of tricyclic (e.g., amitriptyline) or tetracyclic (e.g., maprotiline) antidepressants and levothyroxine may increase the therapeutic and toxic effects of both drugs, possibly due to increased receptor sensitivity to catecholamines. Toxic effects may include increased risk of cardiac arrhythmias and central nervous system stimulation. Levothyroxine may accelerate the onset of action of tricyclics. Administration of sertraline in patients stabilized on levothyroxine may result in increased levothyroxine requirements.

7.6 Ketamine

SPL UNCLASSIFIED SECTION

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

7.7 Sympathomimetics

SPL UNCLASSIFIED SECTION

Concurrent use may of sympathomimetics and levothyroxine 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 Drug-Laboratory Test Interactions

DRUG & OR LABORATORY TEST INTERACTIONS SECTION

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 9,000.

8 USE IN SPECIFIC POPULATIONS

USE IN SPECIFIC POPULATIONS SECTION

8.1 Pregnancy

PREGNANCY SECTION

SPL UNCLASSIFIED SECTION

Risk Summary

There is no available data with use of Levothyroxine Sodium Injection in pregnant women. The clinical data in pregnant women treated with oral levothyroxine to maintain a euthyroid state have not reported increased rates of major birth defects, miscarriages, or adverse maternal or fetal outcomes (see Data). There are risks to the mother and fetus associated with myxedema coma in pregnancy (see Clinical Considerations). Animal reproduction studies have not been conducted with levothyroxine sodium.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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.

SPL UNCLASSIFIED SECTION

Clinical Considerations

SPL UNCLASSIFIED SECTION

Disease-Associated Maternal and/or Embryo/Fetal Risk

Myxedema coma is a medical emergency which can be fatal, if left untreated. Delaying treatment in pregnant women with myxedema coma increases the risk of maternal and fetal morbidity and mortality. Life-sustaining therapy for the pregnant woman should not be withheld due to potential concerns regarding the effects of Levothyroxine Sodium Injection on the fetus.

SPL UNCLASSIFIED SECTION

Data

SPL UNCLASSIFIED SECTION

Human Data

There is no available data with use of Levothyroxine Sodium Injection in pregnant women. Oral levothyroxine is approved for use as a replacement therapy in hypothyroidism. There is a long experience of oral levothyroxine use in pregnant women that has not reported increased rates of fetal malformations, miscarriages or other adverse maternal or fetal outcomes associated with levothyroxine use in pregnant women.

8.2 Lactation

LACTATION SECTION

SPL UNCLASSIFIED SECTION

Risk Summary

Published studies report that levothyroxine is present in human milk following the administration of oral levothyroxine. However, there is insufficient information to determine the effects of levothyroxine on the breastfed infant and no available information on the effects of levothyroxine on milk production. There is no available data with use of Levothyroxine Sodium Injection in lactating women. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for levothyroxine and any potential adverse effects on the breastfed infant from levothyroxine or from the underlying maternal condition.

8.4 Pediatric Use

PEDIATRIC USE SECTION

The safety and efficacy of Levothyroxine Sodium Injection have not been established in pediatric patients.

8.5 Geriatric Use

GERIATRIC USE SECTION

Because of the increased prevalence of cardiovascular disease among the elderly, initiate Levothyroxine Sodium Injection with lower doses in elderly patients and in patients with underlying cardiovascular disease and closely monitor for cardiac adverse reactions. Atrial arrhythmias can occur in elderly patients. Atrial fibrillation is the most common of the arrhythmias observed with levothyroxine overtreatment in the elderly [see Dosage and Administration (2.1) and Warnings and Precautions (5.1)].

10 OVERDOSAGE

OVERDOSAGE SECTION

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. Reduce the Levothyroxine Sodium Injection dose or temporarily discontinue if signs or symptoms of overdosage occur. Initiate appropriate supportive treatment as dictated by the patient's medical status.

11 DESCRIPTION

DESCRIPTION SECTION

Levothyroxine Sodium Injection contains synthetic crystalline levothyroxine (T4) in sodium salt form. Levothyroxine sodium has an empirical formula of C₁₅H₁₀I₄NNaO₄, a molecular weight of 798.85 g/mol (anhydrous), and the following structural formula:

Levothyroxine Sodium Injection is a sterile, preservative free, clear, colorless, sterile solution for intravenous administration available as: 100 mcg per 5 mL (20 mcg per mL). Each mL of Levothyroxine Sodium Injection also contains 10 mg Tromethamine, USP; 0.14 mg Sodium Iodide, USP; 6.48 mg Sodium Chloride, USP; and Water for Injection, USP Sodium hydroxide, NF and/or Hydrochloric acid, USP may have been added for pH adjustment (9.5 – 10.8). Levothyroxine Sodium Injection is in single dose clear glass vials.

12 CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

12.1 Mechanism of Action

MECHANISM OF ACTION SECTION

Thyroid hormones exert their physiologic actions through control of DNA transcription and protein synthesis. Triiodothyronine (T3) and levothyroxine (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

PHARMACODYNAMICS SECTION

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.

12.3 Pharmacokinetics

PHARMACOKINETICS SECTION

SPL UNCLASSIFIED SECTION

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)].

SPL UNCLASSIFIED SECTION

Metabolism

T4 is slowly eliminated. The major pathway of thyroid hormone metabolism is through sequential deiodination. Approximately eighty percent 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.

SPL UNCLASSIFIED SECTION

Excretion

Thyroid hormones are primarily eliminated by the kidneys. A portion of the conjugated hormone reaches the colon unchanged, where it is hydrolyzed and eliminated in feces as the free hormones. Urinary excretion of T4 decreases with age.

Table 1: Pharmacokinetic Parameters of Thyroid Hormones in Euthyroid Patients
Note T₄: Levothyroxine
Note T₃: Liothyronine
Note ¹ 3 to 4 days in hyperthyroidism, 9 to 10 days in hypothyroidism.
Note ² Includes TBG, TBPA, and TBA.
Hormone	Ratio in Thyroglobulin	Biologic Potency	Half-Life (Days)	Protein Binding (%)²
T₄	10 to 20	1	6 to 8¹	99.96
T₃	1	4	≤ 2	99.5

13 NONCLINICAL TOXICOLOGY

NONCLINICAL TOXICOLOGY SECTION

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

Animal studies have not been performed to evaluate the carcinogenic potential, mutagenic potential or effects on fertility of Levothyroxine Sodium Injection.

16 HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

Levothyroxine Sodium Injection is a clear, colorless solution available as follows:

NDC	Total Strength per Total Volume	Concentration
63323-885-12	100 mcg per 5 mL	20 mcg per mL

Protect from light in the original vial in a carton and store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. The unopened vial may be stored for up to 24 hours exposed to indoor lighting outside of the carton. The drug product is preservative free. Discard any unused portion.

PREMIERProRx^® is a registered trademark of Premier Healthcare Alliance, L.P., used under license.

Manufactured by:
Fresenius Kabi
Lake Zurich, IL 60047

www.fresenius-kabi.com/us

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL - PRINCIPAL DISPLAY – Levothyroxine Sodium Injection 5 mL Vial Label
NDC 63323-885-12
Levothyroxine Sodium

Injection
100 mcg per 5 mL

(20 mcg per mL)
For intravenous use.

Preservative free.

5 mL Single-Dose Vial-

Discard Unused Portion

PACKAGE LABEL - PRINCIPAL DISPLAY – Levothyroxine Sodium Injection 5 mL Vial Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL - PRINCIPAL DISPLAY – Levothyroxine Sodium Injection 5 mL Carton
NDC 63323-885-12
Levothyroxine Sodium

Injection
100 mcg per 5 mL

(20 mcg per mL)
For intravenous use.

Preservative free.

5 mL Single-Dose Vial-

Discard Unused Portion

Rx only

PACKAGE LABEL - PRINCIPAL DISPLAY – Levothyroxine Sodium Injection 5 mL Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
2166193	levothyroxine sodium 100 MCG in 5 mL Injection	PSN	1
2166193	5 ML levothyroxine sodium 0.02 MG/ML Injection	SCD	1
2166193	levothyroxine sodium 100 MCG per 5 ML Injection	SY	1
2166193	levothyroxine sodium 20 MCG/ML in 5 ML Injection	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
LEVOTHYROXINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75	Product name	2	20250814
97c252d3-9bb8-4530-bb44-9824dc7cf556	Product name	6	20250729
6c43b71c-35e6-4db3-ba24-c6ef42ff7003	Product name	3	20240207
890fd4bf-1a80-42b7-be1b-2d0259d5f0c8	Product name	5	20240207
c8ad26bf-af73-460b-b74e-1eff16cc4f9f	Product name	5	20240207
01383843-4069-43cf-aa76-dc17a6f9f8c4	Product name	2	20230123
978cca7d-a938-4791-8322-da48d90a63ef	Product name	1	20230113
65f86ba3-8816-4e12-899b-18290c8de551	Product name	2	20210614
f16ab90f-08c2-40be-a543-66d9827cd1f3	Product name	1	20210601
6a33ec05-2ae2-45e5-ab82-2d94b3303923	Product name	1	20190709
93355a10-1c44-4c92-a11d-7d995e0200d9	Product name	1	20190219

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63323-885-12	Levothyroxine Sodium	5 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	5		1
63323-885-12	Levothyroxine Sodium	1 in 1 CARTON	INJECTION, SOLUTION	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-885	LEVOTHYROXINE SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1	Current NDC, Legacy NDC, 2 package rows	20201210_50b1c8a4-75b6-49c8-80fc-3841ee80b183.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-885-10	ML - Milliliter	63323-885	d4060697-dbe3-41da-84bb-1a1e213d57a1	1	2019-06-19
63323-885-12	ML - Milliliter	63323-885	fd862941-90d5-4e9d-973b-75c6f82ef0a4	1	2021-03-02
63323-885-14	ML - Milliliter	63323-885	1aa98018-ab28-492b-8922-3ae6eaf6a42e	1	2021-03-02

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

Levothyroxine Sodium
Levothyroxine
Levothyroxine Sodium Anhydrous
Tromethamine
Sodium Iodide
Sodium Chloride
Sodium Hydroxide
Hydrochloric Acid

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63323-885	63323-885-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Levothyroxine sodium	9J765S329G	ACTIR
Tromethamine	023C2WHX2V	IACT
Sodium Iodide	F5WR8N145C	IACT
Sodium Chloride	451W47IQ8X	IACT
Sodium Hydroxide	55X04QC32I	IACT
Hydrochloric Acid	QTT17582CB	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N210632-001	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	100MCG/5ML (20MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11
N210632-002	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	200MCG/5ML (40MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11
N210632-003	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	500MCG/5ML (100MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N210632-001	10398669	2036-12-01	Drug product	2019-09-13
N210632-001	11135190	2036-12-01	Drug product	2021-10-07
N210632-001	12636270	2036-12-01	Drug product	2026-06-18
N210632-001	9782376	2036-12-01	Drug product	2019-06-11
N210632-002	10398669	2036-12-01	Drug product	2019-09-13
N210632-002	11135190	2036-12-01	Drug product	2021-10-07
N210632-002	12636270	2036-12-01	Drug product	2026-06-18
N210632-002	9782376	2036-12-01	Drug product	2019-06-11
N210632-003	10398669	2036-12-01	Drug product	2019-09-13
N210632-003	11135190	2036-12-01	Drug product	2021-10-07
N210632-003	12636270	2036-12-01	Drug product	2026-06-18
N210632-003	9782376	2036-12-01	Drug product	2019-06-11

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N210632-001	LEVOTHYROXINE SODIUM	100MCG/5ML (20MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210632-002	LEVOTHYROXINE SODIUM	200MCG/5ML (40MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210632-003	LEVOTHYROXINE SODIUM	500MCG/5ML (100MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N210632-001	LEVOTHYROXINE SODIUM	100MCG/5ML (20MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210632-002	LEVOTHYROXINE SODIUM	200MCG/5ML (40MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210632-003	LEVOTHYROXINE SODIUM	500MCG/5ML (100MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210632-001	LEVOTHYROXINE SODIUM	100MCG/5ML (20MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210632-002	LEVOTHYROXINE SODIUM	200MCG/5ML (40MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210632-003	LEVOTHYROXINE SODIUM	500MCG/5ML (100MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210632-001	LEVOTHYROXINE SODIUM	100MCG/5ML (20MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210632-002	LEVOTHYROXINE SODIUM	200MCG/5ML (40MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210632-003	LEVOTHYROXINE SODIUM	500MCG/5ML (100MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210632-001	LEVOTHYROXINE SODIUM	100MCG/5ML (20MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210632-002	LEVOTHYROXINE SODIUM	200MCG/5ML (40MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210632-003	LEVOTHYROXINE SODIUM	500MCG/5ML (100MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210632-001	LEVOTHYROXINE SODIUM	100MCG/5ML (20MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210632-002	LEVOTHYROXINE SODIUM	200MCG/5ML (40MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210632-003	LEVOTHYROXINE SODIUM	500MCG/5ML (100MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210632-001	LEVOTHYROXINE SODIUM	100MCG/5ML (20MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210632-002	LEVOTHYROXINE SODIUM	200MCG/5ML (40MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210632-003	LEVOTHYROXINE SODIUM	500MCG/5ML (100MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210632-001	LEVOTHYROXINE SODIUM	100MCG/5ML (20MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210632-002	LEVOTHYROXINE SODIUM	200MCG/5ML (40MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210632-003	LEVOTHYROXINE SODIUM	500MCG/5ML (100MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210632-001	LEVOTHYROXINE SODIUM	100MCG/5ML (20MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210632-002	LEVOTHYROXINE SODIUM	200MCG/5ML (40MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210632-003	LEVOTHYROXINE SODIUM	500MCG/5ML (100MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210632-001	LEVOTHYROXINE SODIUM	100MCG/5ML (20MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210632-002	LEVOTHYROXINE SODIUM	200MCG/5ML (40MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210632-003	LEVOTHYROXINE SODIUM	500MCG/5ML (100MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210632-001	LEVOTHYROXINE SODIUM	100MCG/5ML (20MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210632-002	LEVOTHYROXINE SODIUM	200MCG/5ML (40MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210632-003	LEVOTHYROXINE SODIUM	500MCG/5ML (100MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210632-001	LEVOTHYROXINE SODIUM	100MCG/5ML (20MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210632-002	LEVOTHYROXINE SODIUM	200MCG/5ML (40MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210632-003	LEVOTHYROXINE SODIUM	500MCG/5ML (100MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210632-001	LEVOTHYROXINE SODIUM	100MCG/5ML (20MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210632-002	LEVOTHYROXINE SODIUM	200MCG/5ML (40MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210632-003	LEVOTHYROXINE SODIUM	500MCG/5ML (100MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210632-001	LEVOTHYROXINE SODIUM	100MCG/5ML (20MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`301d65b070ca…`

Observed Orange Book patent history#

Patent history page 1 of 10 · 366 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N210632-001	10398669	2036-12-01	Drug product	2019-09-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210632-001	11135190	2036-12-01	Drug product	2021-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210632-001	12636270	2036-12-01	Drug product	2026-06-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210632-001	9782376	2036-12-01	Drug product	2019-06-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210632-002	10398669	2036-12-01	Drug product	2019-09-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210632-002	11135190	2036-12-01	Drug product	2021-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210632-002	12636270	2036-12-01	Drug product	2026-06-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210632-002	9782376	2036-12-01	Drug product	2019-06-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210632-003	10398669	2036-12-01	Drug product	2019-09-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210632-003	11135190	2036-12-01	Drug product	2021-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210632-003	12636270	2036-12-01	Drug product	2026-06-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210632-003	9782376	2036-12-01	Drug product	2019-06-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N210632-001	10398669	2036-12-01	Drug product	2019-09-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210632-001	11135190	2036-12-01	Drug product	2021-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210632-001	12636270	2036-12-01	Drug product	2026-06-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210632-001	9782376	2036-12-01	Drug product	2019-06-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210632-002	10398669	2036-12-01	Drug product	2019-09-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210632-002	11135190	2036-12-01	Drug product	2021-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210632-002	12636270	2036-12-01	Drug product	2026-06-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210632-002	9782376	2036-12-01	Drug product	2019-06-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210632-003	10398669	2036-12-01	Drug product	2019-09-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210632-003	11135190	2036-12-01	Drug product	2021-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210632-003	12636270	2036-12-01	Drug product	2026-06-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210632-003	9782376	2036-12-01	Drug product	2019-06-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210632-001	10398669	2036-12-01	Drug product	2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210632-001	11135190	2036-12-01	Drug product	2021-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210632-001	9782376	2036-12-01	Drug product	2019-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210632-002	10398669	2036-12-01	Drug product	2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210632-002	11135190	2036-12-01	Drug product	2021-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210632-002	9782376	2036-12-01	Drug product	2019-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210632-003	10398669	2036-12-01	Drug product	2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210632-003	11135190	2036-12-01	Drug product	2021-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210632-003	9782376	2036-12-01	Drug product	2019-06-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210632-001	10398669	2036-12-01	Drug product	2019-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210632-001	11135190	2036-12-01	Drug product	2021-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210632-001	9782376	2036-12-01	Drug product	2019-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210632-002	10398669	2036-12-01	Drug product	2019-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210632-002	11135190	2036-12-01	Drug product	2021-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210632-002	9782376	2036-12-01	Drug product	2019-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210632-003	10398669	2036-12-01	Drug product	2019-09-13	`31067a03dcf5…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Fresenius Kabi USA, LLC	08f4b1f8-6807-47e7-bef8-8d1972aa0557	2025-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 63323-885
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Fresenius Kabi USA, LLC	388a1f15-8c1c-46a5-997f-7f326f696b59	2020-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 63323-885
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Fresenius Kabi USA, LLC	50b1c8a4-75b6-49c8-80fc-3841ee80b183	2020-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (package): 63323-885-12 ndc (product): 63323-885 ndc11 (package): 63323088512 spl id: b76cd786-4b5c-4f96-bbbf-a7399d50fb27 spl set id: 50b1c8a4-75b6-49c8-80fc-3841ee80b183

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.