THE 1ST FDA-APPROVED levothyroxine sodium treatment for hypothyroidism1,2
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By delivering quality, consistency, and affordability, all in one, UNITHROID can help get your patients where they need to be no matter which way life turns.
Treatment for Hypothyroidism that's

There at Every Turn

By delivering quality, consistency, and affordability, all in one, UNITHROID can help get your patients where they need to be no matter which way life turns.
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For a high-quality treatment turn to Unithroid

UNITHROID is the first FDA-approved levothyroxine sodium treatment for hypothyroidism.1,2 Below are just a few of many reasons why more and more healthcare providers are turning to UNITHROID for their patients with hypothyroidism.

Manufacturing facility
Made in 1 facility

UNITHROID has been consistently manufactured in the same state-of-the-art facility since it was first introduced more than 2 decades ago.3

New York City skyline
Made in the USA

UNITHROID is manufactured exclusively in New York, which helps ensure consistency and quality of the product.3

Contains no gluten
Gluten Free

UNITHROID contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).3

UNITHROID production adheres to Current Good Manufacturing Practices (CGMP)
The CGMP is an FDA initiative that helps ensure the quality of drug products. The regulations make sure that a product has the ingredients and strength it claims to, and is safe.4

When Treating Hypothyroidism CONSISTENCY MATTERS

When treating hypothyroidism, it can be important to know that your patients are receiving the exact same medication you prescribed with each and every refill.

In fact, ATA/AACE Guidelines recommend that patients should be maintained on the same levothyroxine preparation. The guidelines also state that patients should have their serum TSH retested after 4 to 8 weeks if they are switched to a different levothyroxine preparation.5

A prescription pad showing UNITHROID 25 mcg, with DAW or 'dispense as written' printed below

Initial Prescription  Unithroid

Refill 1  Unithroid

Refill 2  Unithroid

Refill 3  Unithroid
Tablets shown not actual size.
INDICATE UNITHROID ONLY

Prescribing UNITHROID by name—and writing dispense as written (DAW)—provides assurance that patients consistently receive the same levothyroxine preparation with every refill instead of various generic substitutes.

NO HISTORY OF RECALLS OR REFORMULATIONS

UNITHROID has been manufactured for more than 20 years with no recalls, reformulations, or gaps in availability.3

AACE Guidelines
Because levothyroxine has a narrow therapeutic range, small differences in absorption can result in subclinical or clinical hypothyroidism or hyperthyroidism.6

Or equivalent language in your state.
AACE=American Association of Clinical Endocrinologists; ATA=American Thyroid Association.
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Because levothyroxine has a narrow therapeutic index, careful dosage titration is necessary to avoid over- or under-treatment.1

Recommended TSH Ranges (mIU/L)5,7
Graph showing recommended TSH ranges Graph showing recommended TSH ranges
NACB=National Academy of Clinical Biochemistry.

Turn to Unithroid to Help your patients save

When managing hypothyroidism, consistency matters, from taking medicine the same way, every day, to making sure patients always receive the exact treatment you prescribe.

We know that cost is an important consideration when selecting a treatment option for a life-long condition. That’s why we're happy to let you know:

More than 90% of commercially insured patients pay as little as
$3
For a 30-day
Prescription3,‡

Subject to eligibility. Individual out-of-pocket costs may vary. Not valid for patients covered under Medicare, Medicaid, or other federal or state programs.
Please see full Eligibility Criteria and Terms and Conditions below.

Of commercially insured UNITHROID patients, 90% paid a $3 co-pay for a 30-day supply from September 2018-October 2019.3
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TWO WAYS TO SAVE
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eVOUCHER Rx™ PROGRAM
  • No cards or coupons needed
  • Most patients with commercial insurance will receive an automatic co-pay reduction at participating pharmacies when picking up a UNITHROID prescription
SAVINGS CARD
  • Click the button below to find out how patients can download a Savings Card
  • Patients should show their Savings Card to the pharmacist when they pick up their UNITHROID prescription. The pharmacist will apply the co-pay reduction at the pharmacy counter if the pharmacy does not participate in the eVoucher Program
  • Cash-paying patients (patients without insurance coverage) may also participate in this offer, unless they do not meet eligibility criteria as listed below
Terms, Conditions, and Eligibility Criteria:
  1. This card is not valid for prescriptions submitted for reimbursement to Medicare, Medicaid, Medigap, VA or DOD or TriCare or where prohibited by law, or other federal or state programs (including any state pharmaceutical assistance programs), or private indemnity or HMO insurance plans that reimburse you for the entire cost of your prescription drugs. Patients may not use this card if UNITHROID is covered under their Medicare prescription drug plan or if they are Medicare-eligible and enrolled in an employer-sponsored health plan or prescription drug benefit program for retirees.
  2. This card is good for use only with a UNITHROID prescription at the time the prescription is filled by the pharmacist and dispensed to the patient.
  3. This offer is good for 18 uses per patient or until the program expires, whichever comes first.
  4. Maximum reimbursement limits apply; patient out-of-pocket expense may vary.
  5. Amneal reserves the right to rescind, revoke, or amend this offer without notice.
  6. Offer good only in the US, except California and Massachusetts, at participating retail pharmacies.
  7. Void if prohibited by law, taxed, or restricted.
  8. The selling, purchasing, trading, or counterfeiting of this card is prohibited by law.
  9. If a patient redeems this card, they acknowledge that they understand and agree to comply with the terms and conditions of this offer stated above and all LoyaltyScripts® program Terms and Conditions posted at www.mckesson.com/mprstnc.
By clicking the button below, I certify that I am 18 years of age or older, have read and accept the program terms, conditions, and eligibility, and not covered by:
  • Any federal or state healthcare program, such as Medicare, Medicaid, etc, including state medical or pharmaceutical assistance programs;
  • The Medicare Prescription Drug Program (Part D), or in the coverage gap; or
  • Insurance that is paying the entire cost of the prescription
See how your patients can download a Savings Card.

A full array of Dosage strengths

UNITHROID IS AVAILABLE IN
12 Strengths1
  • All 12 strengths are therapeutically equivalent to other branded synthetic levothyroxine products8
  • Allows you to precisely titrate treatment and achieve TSH levels within an appropriate therapeutic range
Tablets shown not actual size.
Available sample dosages of UNITHROID, 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, and 125 mcg Available sample dosages of UNITHROID, 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, and 125 mcg
Various dosages of UNITHROID, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg
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GETTING PATIENTS STARTED TODAY
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UNITHROID is available in 2-week samples in 7 strengths
  • Allows your patients to begin treatment without delay
  • Gives pharmacies time to obtain a specific dosage strength in case they don't currently have it in stock
Get samples of UNITHROID

If you would like to receive UNITHROID samples, ask your UNITHROID representative, or email samplerequest@amneal.com.

In the email, please include your name, address, and the sample strengths you are most interested in receiving.

Information for Ordering Unithroid1

UNITHROID is available

If your patient’s pharmacy does not currently stock their prescribed dosage strength, or you and your patients have questions or are experiencing other issues getting UNITHROID, please email or call us.

Strength
(mcg)
NDCAmerisourceBergenCardinal HealthMcKesson
2560846-0801-011014114949993143421427
5060846-0802-011014117049993303421690
7560846-0803-011014117149993483422870
8860846-0804-011014117249994053423001
10060846-0805-011014117349994133423829
11260846-0806-011014117449994213423092
12560846-0807-011014117549994473423100
13760846-0808-011014117649994543425378
15060846-0809-011014117749992723423183
17560846-0810-011014117849992563423738
20060846-0811-011014117949992493424447
30060846-0812-011014118049992233424900
Important Safety Information
WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS
Thyroid hormones, including UNITHROID, 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.

Contraindication

UNITHROID is contraindicated in patients with uncorrected adrenal insufficiency.

Warnings and Precautions

  • Overtreatment with UNITHROID 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 UNITHROID therapy at lower doses than those recommended in younger individuals or in patients without cardiac disease.
  • Coronary artery disease: Patients receiving UNITHROID should be monitored closely during surgical procedures for cardiac arrhythmias. Also, monitor patients during concomitant administration of UNITHROID and sympathomimetic agents for signs and symptoms of coronary insufficiency.
  • Myxedema coma: is a life-threatening emergency characterized by poor circulation and hypometabolism, and may result in unpredictable absorption of UNITHROID from the gastrointestinal tract. Use of oral thyroid hormone drug products is not recommended. Administer intravenous thyroid hormone products to treat myxedema coma.
  • Acute adrenal crisis in patients with concomitant adrenal insufficiency: thyroid hormone increases metabolic clearance of glucocorticoids. Initiation of thyroid hormone therapy prior to initiating glucocorticoid therapy may precipitate an acute adrenal crisis in patients with adrenal insufficiency.
  • UNITHROID has a narrow therapeutic index. Titrate the dose of UNITHROID carefully and monitor response to titration to avoid effects of over or under treatment with UNITHROID. Monitor for the presence of drug or food interactions when using UNITHROID and adjust the dose as necessary.
  • 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 UNITHROID.
  • Increased bone resorption and decreased bone mineral density may occur as a result of levothyroxine over-replacement, particularly in post-menopausal women. To minimize this risk, administer the minimum dose of UNITHROID that achieves the desired clinical and biochemical response.

Adverse Reactions

  • Common adverse reactions for UNITHROID 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.
  • 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 and premature closure of the epiphyses in pediatric patients with resultant compromised adult height.

Drug Interactions

  • Many drugs can exert effects on thyroid hormone pharmacokinetics and may alter the therapeutic response to UNITHROID. Administer at least 4 hours before or after drugs that are known to interfere with absorption. Consumption of certain foods may affect absorption of UNITHROID, resulting in the need for dose adjustment. Consult appropriate sources of information on drug or food interactions for additional information relative to drug or food interactions with UNITHROID.
  • 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.

Use in Specific Populations

  • Pregnancy: Since thyroid-stimulating hormone (TSH) levels may increase during pregnancy, TSH should be monitored and UNITHROID dosage adjusted during pregnancy. UNITHROID should not be discontinued during pregnancy and hypothyroidism diagnosed during pregnancy should be promptly treated.
Indication

UNITHROID is L-thyroxine (T4) indicated in pediatric and adult patients for:

  • Hypothyroidism: As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism
  • 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

Limitations of Use:

UNITHROID is 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 UNITHROID may induce hyperthyroidism. UNITHROID is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.

To report SUSPECTED ADVERSE REACTIONS, contact Amneal Specialty, a division of Amneal Pharmaceuticals LLC at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information.

References: 1. UNITHROID [package insert]. 2. US Food and Drug Administration. Guidance for Industry: levothyroxine sodium products enforcement of August 14, 2001, compliance date and submission of new applications. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/levothyroxine-sodium-products-enforcement-august -14-2001-compliance-date-and-submission-new. Updated July 2001. Accessed August 20, 2019. 3. Data on file. Amneal Pharmaceuticals LLC. 4. US Food and Drug Administration. Current good manufacturing practice (CGMP) regulations. www.fda.gov/drugs/pharmaceutical-quality-resources/current. Accessed August 20, 2019. 5. Garber JR, Cobin RH, Gharib H, et al. Clinical Practice Guidelines for Hypothyroidism in Adults: cosponsored by the American Association of Clinical Endocrinologists and the American Thyroid Association. Endocr Pract. 2012;18(6):988–1028. 6. Baskin HJ, Cobin RH, Duick DS, et al; for American Association of Clinical Endocrinologists. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the evaluation and treatment of hyperthyroidism and hypothyroidism. Endocr Pract. 2002;8(6):457-469. 7. Demers LM, Spencer CA, eds; National Academy of Clinical Biochemistry. Laboratory medicine practice guidelines: laboratory support for the diagnosis of thyroid disease. https://www.aacc.org/~/media/practice-guidelines/thyroid-disease/thyroidarchived2010.pdf?la=en. Published 2002. Accessed August 20, 2019. 8. US Department of Health and Human Services. Orange Book: Approved drugs with therapeutic equivalence evaluations, 39th ed. https://www.fda.gov/media/71474/download. Published 2019. Accessed September 11, 2019.
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