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ERMEZA levothyroxine sodium 30 ug/mL Solution — NDC 49502-378-75 (Billing 49502-0378-75)

by Viatris Specialty LLC · 1 BOTTLE, GLASS in 1 CARTON / 75 mL in 1 BOTTLE, GLASS

This is a package of ERMEZA levothyroxine sodium 30 ug/mL Solution from Viatris Specialty LLC, no longer marketed (first marketed Dec 2022), no longer in the FDA NDC Directory, this package's marketing ended Jul 2026; retail pharmacies pay about $1.72 per mL (NADAC). It is the main listing for this product, which comes in 2 package sizes.

NDC 49502-0378-75
🏷️ FDA NDC (as labeled) 49502-378-75 billing pads the product segment with a zero
This package
Contains75 mL in 1 bottle, glass Cost per mL$1.72 NADAC Per package$129.18 / 75 ml Pack sizes2 compare ↓
Also priced by: Medicaid pays $1.82/unit · Part D plans $1.89/unit — full pricing hub ↓
Main listing for product 49502-378 · Also comes in: 150 mL 49502-378-15
Rx only Brand Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Levothyroxine Sodium (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 6, 2026 — Subpotent Drug (ACCORD HEALTHCARE, INC.) · FDA recall D-0776-2026
Class II · Aug 6, 2026 — Subpotent Drug (ACCORD HEALTHCARE, INC.) · FDA recall D-0781-2026
Class II · Aug 6, 2026 — Subpotent Drug (ACCORD HEALTHCARE, INC.) · FDA recall D-0775-2026
Class II · Aug 6, 2026 — Subpotent Drug (ACCORD HEALTHCARE, INC.) · FDA recall D-0782-2026
Class II · Aug 6, 2026 — Subpotent Drug (ACCORD HEALTHCARE, INC.) · FDA recall D-0786-2026
Class II · Aug 6, 2026 — Subpotent Drug (ACCORD HEALTHCARE, INC.) · FDA recall D-0780-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Jul 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 49502-378-75
Product NDC 49502-378
11-digit billing NDC 49502037875
NCPDP billing unit ML — per mL (volume)
RxCUI 2626050, 2626056
UNII 9J765S329G
Application # NDA215809
SPL Set ID 8ceeadb4-18be-46c7-9204-68b4edfbb96b
Established class (EPC) l-Thyroxine
Chemical class Thyroxine
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Jul 2026)
Marketing start 2022-12-14
Marketing end 2026-07-31
Route ORAL
Dosage form SOLUTION
Substance LEVOTHYROXINE SODIUM

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 083382
GCN 52325
HICL code 002849
Ingredient (HICL) Levothyroxine Sodium
HIC1 code P
Therapeutic class — broad (HIC1) Endocrine System
HIC2 code P3
Therapeutic class — intermediate (HIC2) Drugs Affecting Thyroid Function
HIC3 code P3A
Therapeutic class — specific (HIC3) Thyroid Hormones
AHFS code 68:36.04.00
AHFS class Thyroid Agents
FDB label name ERMEZA 150 MCG/5 ML SOLUTION
FDB brand name Ermeza
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 083382
  • GCN: 52325
  • HICL (First Databank): 002849
  • AHFS class code: 68:36.04.00
  • RxCUI (RxNorm): 2626050
Why two NDCs? The FDA registers this code as 49502-378-75 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 49502-0378-75. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the l-Thyroxine class.

Pharmacologic class l-Thyroxine
Drug family (ATC) Thyroid hormones
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name ERMEZA 150 MCG/5 ML SOLUTION Ingredient Levothyroxine Sodium
📖 What it is MedlinePlus · NLM

Levothyroxine is used to treat hypothyroidism (condition where the thyroid gland does not produce enough thyroid hormone). It is also used with surgery and radioactive iodine therapy to treat thyroid cancer. Levothyroxine is in a class of medications called hormones. It works by replacing thyroid hormone that is normally produced by the body. Without thyroid hormone, your body cannot function properly, which may result in poor growth, slow speech, lack of energy, excessive tiredness, constipation, weight gain, hair loss, dry, thick skin, increased sensitivity to cold, joint and muscle pain, he...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It replaces thyroid hormone when your thyroid doesn’t make enough, a condition called hypothyroidism. Oral forms are also used with surgery and radioiodine for certain thyroid canc...
  • Oral forms are usually taken once a day on an empty stomach, about 15 to 60 minutes before breakfast, depending on the product. Keep calcium, iron and antacids at least 4 hours awa...
  • Full effect may take 4 to 6 weeks. Your doctor will check TSH and/or T4 blood tests to adjust your dose.
  • No. It doesn’t cause weight loss at normal doses if your thyroid is normal. Larger doses can be seriously toxic.
📖 Read our full Levothyroxine guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer mLPer package
Retail pharmacies payNADAC · weekly $1.722 $129.18 / 75 ml
Medicaid paysCMS SDUD · 12 mo $1.82 $136.87 / 75 ml
Medicare drug plans payPart D · Q2 2026 $1.89 $141.80 / 75 ml
NADAC price history (per mL) — tap or hover for the price & month
Nov 2025 $1.722 $1.722
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
49502-0378-15 49502-378-15 1 BOTTLE, GLASS in 1 CARTON / 150 mL in 1 BOTTLE, GLASS — — 2022-12-14 Jul 31, 2026 Discontinued by firm
49502-0378-75 You're viewing this Main listing 1 BOTTLE, GLASS in 1 CARTON / 75 mL in 1 BOTTLE, GLASS $1.72 / mL $129.18 2022-12-14 Jul 31, 2026 Discontinued by firm

In Medicaid, this is the most-dispensed pack of this product — about 52% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle, glass in 1 carton / 75 ml in 1 bottle, glass.
What NDC number is used to bill for this package of ERMEZA levothyroxine sodium 30 ug/mL Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ermeza 30 ug/mLthis 49502-0378-75 Viatris 1 bottle $1.722 — Discontinued —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2022
First FDA approval
Apr 2022
📍
2026
Currently FDA-listed
4 years listed
🛡️
2035
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Feb 2035. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Apr 29, 2022 RLD RS ⏳ ~8.4 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 9345772 — drug product
2022 2024 2026 2028 2030 2032 2034
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (1)
PatentTypeUse codeExpires
US 9345772 ↗ Drug product — Feb 27, 2035
Common questions
Is there a generic version of ERMEZA 150 MCG/5 ML SOLUTION?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for ERMEZA 150 MCG/5 ML SOLUTION. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Feb 2035 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerViatris Specialty LLC
Application holderMYLAN PHARMACEUTICALS INC
FDA applicationNDA215809 (NDA)
Labeler code49502
First marketedDec 2022
Product typeHuman Prescription Drug
Portfolio120 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 151 words ▾

WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS Thyroid hormones, including ERMEZA, 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 ERMEZA, 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 212 words ▾

1 INDICATIONS AND USAGE Hypothyroidism ERMEZA is 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 ERMEZA is 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: • ERMEZA 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 ERMEZA may induce hyperthyroidism [see Warnings and Precautions (5.1) ]. • ERMEZA is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.

ERMEZA is levothyroxine sodium (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: 3.

Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients 4. Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis

⏱️ Dosage and Administration ~3 min read ▾

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 levothyroxine absorption.

( 2.1 ) • Administer orally using the appropriate syringe provided in the original carton. The 5 mL syringe should be used for doses up to 5 mL. The 10 mL syringe should be used for doses over 5 mL.

( 2.1 , 2.4 ) • Starting dose depends on a variety of factors, including age, body weight, cardiovascular status, and concomitant medical conditions. Peak therapeutic effect may not be attained for 4-6 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. ( 2.5 )

2.1Important Administration Instructions Administer ERMEZA as a single daily oral dose, on an empty stomach, one-half to one hour before breakfast. Administer ERMEZA at least 4 hours before or after drugs known to interfere with levothyroxine absorption [see Drug Interactions (7.1) ] . Evaluate the need for dose adjustments when regularly administering within one hour of certain foods that may affect levothyroxine absorption [see Dosage and Administration (2.2 and 2.3) , Drug Interactions (7.9) and Clinical Pharmacology (12.3) ] .

Convert mcg dosage to mL using the following equation and round up or down to the nearest syringe graduation [see Dosage and Administration (2.4) ]: Administer ERMEZA directly to the mouth using the 5 mL or 10 mL oral syringe provided in the original carton. A household teaspoon or tablespoon is not an adequate measuring device. Instruct patients to read the “Instructions for Use” carefully for complete directions on how to properly dose and administer ERMEZA. mcg dosage to mL conversion

2.2Important Considerations for Dosing ERMEZA oral solution may have a different concentration from other levothyroxine oral solution products. Use caution and consider the total dosage in terms of mcg and not volume (mL) when converting between ERMEZA and other levothyroxine oral solution products. The dosage of ERMEZA 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 (2.5) ] . 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 ERMEZA dosage adequacy and should not be used to monitor therapy.

Use the serum free-T4 level to titrate ERMEZA 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) ] . The peak therapeutic effect of a given dose of ERMEZA 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 ERMEZA 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 fibrillation or patients with underlying cardiac disease, start with a lower dosage and titrate… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 81 words ▾

3 DOSAGE FORMS AND STRENGTHS ERMEZA (levothyroxine sodium) Oral Solution, 150 mcg/ 5 mL (30 mcg/ mL) is a clear, colorless solution supplied in a 90 mL or 180 mL amber glass bottle with a child-resistant closure. ERMEZA is to be used with the 5 mL or 10 mL oral syringe provided in the original carton. Oral Solution: 150 mcg levothyroxine sodium per 5 mL (30 mcg levothyroxine sodium per mL) in 90 mL or 180 mL bottles ( 3 )

⛔ Contraindications 57 words ▾

4 CONTRAINDICATIONS ERMEZA is contraindicated in patients with: • Uncorrected adrenal insufficiency [see Warnings and Precautions (5.4) ] . • Hypersensitivity to glycerin and edetate disodium, inactive ingredients in ERMEZA [see Adverse Reactions (6) and Pediatric Use (8.4) ] . • Uncorrected adrenal insufficiency. ( 4 ) • Hypersensitivity to glycerin and edetate disodium. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Serious risks related to overtreatment or undertreatment of ERMEZA: Titrate the dose of ERMEZA carefully and monitor response to titration. ( 5.1 ) • Cardiac adverse reactions in the elderly and in patients with underlying cardiovascular disease: Initiate ERMEZA 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 ERMEZA 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 of ERMEZA ERMEZA has a narrow therapeutic index. Overtreatment or undertreatment with ERMEZA 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 ERMEZA 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 ERMEZA 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 ERMEZA therapy in this population at lower doses than those recommended in younger individuals or in patients without cardiac disease [see Dosage and Administration (2.3) , Use in Specific Populations (8.5) ] .

Monitor for cardiac arrhythmias during surgical procedures in patients with coronary artery disease receiving suppressive ERMEZA therapy. Monitor patients receiving concomitant ERMEZA and sympathomimetic agents for signs and symptoms of coronary insufficiency. If cardiac symptoms develop or worsen, reduce the ERMEZA 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 prior to initiating glucocorticoid therapy may precipitate an acute adrenal crisis in patients with adrenal insufficiency. Treat patients with adrenal insufficiency with replacement glucocorticoids prior to initiating treatment with ERMEZA [see Contraindications (4) ].

5.5Worsening of… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS Adverse reactions associated with levothyroxine therapy are primarily those of hyperthyroidism due to therapeutic overdosage [see Warnings and Precautions (5) , Overdosage (10) ] . They include the following: • General: fatigue, increased appetite, weight loss, heat intolerance, fever, excessive sweating • Central nervous system: headache, hyperactivity, nervousness, anxiety, irritability, emotional lability, insomnia • Musculoskeletal: tremors, 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 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 Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS See full prescribing information for drugs that affect thyroid hormone pharmacokinetics (e.g., absorption, synthesis, secretion, metabolism, protein binding, and target tissue response) and may alter the therapeutic response to ERMEZA. ( 7 )

7.1Drugs Known to Affect Thyroid Hormone Pharmacokinetics Many drugs can exert effects on thyroid hormone pharmacokinetics (e.g., absorption, synthesis, secretion, metabolism, protein binding, and target tissue response) and may alter the therapeutic response to ERMEZA (Tables 5 to 8). Table 5. Drugs That May Decrease T4 Absorption (Hypothyroidism) Potential impact: Concurrent use may reduce the efficacy of ERMEZA 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 ERMEZA at least 4 hours apart from these agents. Orlistat Monitor patients treated concomitantly with orlistat and ERMEZA for changes in thyroid function.

Bile Acid Sequestrants -Colesevelam -Cholestyramine -Colestipol Ion Exchange Resins -Kayexalate Bile acid sequestrants and ion exchange resins are known to decrease levothyroxine absorption. Administer ERMEZA at least 4 hours prior to these drugs or monitor 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 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 ERMEZA 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 ERMEZA 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… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy may require the use of higher doses of ERMEZA. ( 2.3 , 8.1 )

8.1Pregnancy Risk Summary The clinical experience, including data from post-marketing studies in pregnant women treated with oral levothyroxine, to maintain a 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 hypothyroidism in pregnancy. Since TSH levels may increase during pregnancy, TSH should be monitored, and ERMEZA dosage adjusted during pregnancy (see Clinical Considerations ) .

Animal reproduction studies have not been conducted with levothyroxine sodium. ERMEZA 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 ERMEZA requirements. Serum TSH levels should be monitored, and the ERMEZA dosage adjusted during pregnancy.

Since postpartum TSH levels are similar to preconception values, the ERMEZA 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 sodium. 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 ERMEZA and any potential adverse effects on the breastfed infant from ERMEZA or from the underlying maternal condition.

8.4Pediatric Use ERMEZA 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. Glycerin has the potential to cause gastrointestinal irritation resulting in vomiting and/or osmotic diarrhea. Patients in the first 3 months of life may be particularly susceptible to serious fluid and electrolyte complications from glycerin-induced gastrointestinal irritation.

Closely monitor patients from birth to 3 months of age receiving ERMEZA for signs and symptoms of gastrointestinal irritation. 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 ERMEZA therapy immediately upon diagnosis.

Levothyroxine is generally continued for life in these patients [see Warnings and Precautions (5.1) ] . Closely monitor patients during the first 2 weeks of ERMEZA therapy for cardiac overload and arrhythmias.

8.5Geriatric Use Because of the increased prevalence of cardiovascular disease among the elderly, initiate ERM… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary The clinical experience, including data from post-marketing studies in pregnant women treated with oral levothyroxine, to maintain a 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 hypothyroidism in pregnancy. Since TSH levels may increase during pregnancy, TSH should be monitored, and ERMEZA dosage adjusted during pregnancy (see Clinical Considerations ) .

Animal reproduction studies have not been conducted with levothyroxine sodium. ERMEZA 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 ERMEZA requirements. Serum TSH levels should be monitored, and the ERMEZA dosage adjusted during pregnancy.

Since postpartum TSH levels are similar to preconception values, the ERMEZA dosage should return to the pre-pregnancy dose immediately after delivery [see Dosage and Administration (2.3) ].

🧒 Pediatric Use 174 words ▾

8.4Pediatric Use ERMEZA 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. Glycerin has the potential to cause gastrointestinal irritation resulting in vomiting and/or osmotic diarrhea. Patients in the first 3 months of life may be particularly susceptible to serious fluid and electrolyte complications from glycerin-induced gastrointestinal irritation.

Closely monitor patients from birth to 3 months of age receiving ERMEZA for signs and symptoms of gastrointestinal irritation. 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 ERMEZA therapy immediately upon diagnosis.

Levothyroxine is generally continued for life in these patients [see Warnings and Precautions (5.1) ] . Closely monitor patients during the first 2 weeks of ERMEZA therapy for cardiac overload and arrhythmias.

🧓 Geriatric Use 58 words ▾

8.5Geriatric Use Because of the increased prevalence of cardiovascular disease among the elderly, initiate ERMEZA 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 114 words ▾

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 ERMEZA 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 ~2 min read ▾

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 ERMEZA dose is absorbed from the jejunum and upper ileum. 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 thyroxine-binding 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 9). 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 9.

Pharmacokinetic Parameters of Thyroid Hormones in Euthyroid Patients Hormone Ratio in Thyroglobulin Biologic Potency Half-Life (days) Protein Binding (%) Includes TBG, TBPA, and TBA Levothyroxine (T4) 10 -20 1 6-7 3 to 4 days in hyperthyroidism, 9 to 10 days in hypothyroidism

99.96Liothyronine (T3) 1 4 ≤ 2 99.5

🧬 Mechanism of Action 79 words ▾

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 150 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied ERMEZA (levothyroxine sodium) Oral Solution, 150 mcg/ 5 mL (30 mcg/ mL) is a clear, colorless solution supplied in a 90 mL or 180 mL amber glass bottle with a child-resistant closure. A 5 mL with 0.1 mL graduation and a 10 mL with 0.2 mL graduation oral syringe are provided within the carton to accurately measure the prescribed dose. It is available as follows: NDC 49502-378-75: 75 mL of oral solution filled in 90 mL size amber glass bottles.

NDC 49502-378-15: 150 mL of oral solution filled in 180 mL size amber glass bottles. Storage and Handling Store ERMEZA at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature). ERMEZA oral solution should be protected from light.

Store and dispense in original bottle. Use within 90 days of opening the bottle.

📋 Description 99 words ▾

11 DESCRIPTION ERMEZA (levothyroxine sodium) oral solution contains synthetic L-3,3', 5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland, and is very slightly soluble in water. Levothyroxine (T4) sodium hydrate has an empirical formula of C 15 H 10 I 4 NNaO 4 with x ≈ 5*, molecular weight of 798.86 (anhydrous), and structural formula as shown: ERMEZA oral solution is supplied in the following strength: 150 mcg/5 mL (30 mcg/mL).

ERMEZA oral solution contains the following inactive ingredients: edetate disodium, glycerin, and purified water. Levothyroxine Sodium Structural Formula

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Inform the patient of the following information to aid in the safe and effective use of ERMEZA: Dosing and Administration • Instruct patients to take ERMEZA only as directed by their healthcare provider. • Instruct patients to take ERMEZA once daily, preferably on an empty stomach, one-half to one hour before breakfast. • Instruct patients to always use the 5 mL or 10 mL oral syringe provided in the original carton when administering ERMEZA to ensure that the dose is measured and administered accurately.

Instruct patients to read the “Instructions for Use” carefully for complete directions on how to properly dose and administer ERMEZA. • Inform patients that agents such as iron and calcium supplements and antacids can decrease the absorption of levothyroxine. Instruct patients not to take ERMEZA 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 ERMEZA. Important Information • Inform patients that it may take several weeks before they notice an improvement in symptoms. • Inform patients that the levothyroxine in ERMEZA 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 ERMEZA 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 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 ERMEZA.

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 ERMEZA 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 ERMEZA therapy, but this is usually temporary.

Manufactured for: Mylan Specialty L.P. Morgantown, WV 26505 U.S.A. Manufactured by: DPT Laboratories, Ltd.

San Antonio, TX 78215 U.S.A. LEVOOSN:R1

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Absorption Absorption of orally administered T4 from the gastrointestinal tract ranges from 40% to 80%. The majority of the ERMEZA dose is absorbed from the jejunum and upper ileum. 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 thyroxine-binding 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 9). 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 9.

Pharmacokinetic Parameters of Thyroid Hormones in Euthyroid Patients Hormone Ratio in Thyroglobulin Biologic Potency Half-Life (days) Protein Binding (%) Includes TBG, TBPA, and TBA Levothyroxine (T4) 10 -20 1 6-7 3 to 4 days in hyperthyroidism, 9 to 10 days in hypothyroidism

99.96Liothyronine (T3) 1 4 ≤ 2 99.5

🧬 Pharmacodynamics 29 words ▾

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.

🧪 Nonclinical Toxicology 37 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenicity studies in animals to evaluate the carcinogenic potential of levothyroxine have not been performed. Studies to evaluate mutagenic potential and animal fertility have not been performed.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 34 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenicity studies in animals to evaluate the carcinogenic potential of levothyroxine have not been performed. Studies to evaluate mutagenic potential and animal fertility have not been performed.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION ERMEZA™ [er-meh-zah] (levothyroxine sodium) oral solution What is the most important information I should know about ERMEZA? Do not use ERMEZA to treat weight problems or weight loss. What is ERMEZA?

ERMEZA is a prescription medicine that contains a hormone called levothyroxine which is normally produced by the thyroid gland. ERMEZA is used in adults and children, including newborns: • to replace or give extra levothyroxine when the thyroid does not produce enough of this hormone; or • with surgery and radiodine therapy to manage a type of thyroid cancer called thyroid-dependent well-differentiated thyroid cancer. ERMEZA should not be used to treat people who are recovering from swelling of the thyroid gland (thyroiditis) and whose bodies do not produce enough levothyroxine for a short time.

Do not take ERMEZA: • if your adrenal glands are not working well and you have not been treated for this problem; or • if you are allergic to glycerin or edetate disodium, the inactive ingredients in ERMEZA. Before you take ERMEZA, tell your doctor about all of your medical conditions, including if you: • have or have had heart problems. • have or have had thyroid nodules. • have adrenal or pituitary gland problems. • have any food or drug allergies. • have low red blood cell count (anemia). • have diabetes. • have weak bones (osteoporosis). • have or had a history of blood clotting problems. • have recently received radiation therapy with iodine (such as I-131). • plan to have surgery. • are pregnant or plan to become pregnant.

Your doctor may need to change your ERMEZA dose while you are pregnant. • are breastfeeding. Levothyroxine can pass into your breast milk. Talk to your doctor about the best way to feed your baby if you take ERMEZA.

Tell your doctor about all the medicines you are taking including prescription and over-the-counter medicines, vitamins and herbal supplements. ERMEZA may affect the way other medicines work, and other medicines may affect how ERMEZA works so your doctor may have to adjust the amount of medicines you take. You can ask your doctor or pharmacist for a list of medicines that interact with ERMEZA.

How should I take ERMEZA? • ERMEZA is for oral use only. Do not inhale, inject, or place ERMEZA in the eyes. • See the detailed “Instructions for Use” that come with ERMEZA for information on the right way to take your dose of ERMEZA. • Take ERMEZA exactly as your doctor tells you to take it. • Your doctor will tell you how much ERMEZA to take each day. • Your doctor may change your dose, if needed. • Take your dose of ERMEZA 1 time each day 30 minutes to 1 hour before breakfast on an empty stomach. • Certain medicines can interfere with how levothyroxine is absorbed by your body.

Take ERMEZA: o at least 4 hours before or after you take medicines that contain calcium carbonate or iron (ferrous sulfate); and o at least 4 hours before you take medicines that contain bile acid sequestrants or ion exchange resins. Know the medicines you take. Ask your doctor or pharmacist for a list of these medicines, if you are not sure. • Certain foods including soybean products (such as infant formula and soybean flour), cotton seed meal, walnuts, dietary fiber, and grapefruit juice can affect your treatment and dose of ERMEZA.

Talk to your doctor if you eat or drink these foods. • Use ERMEZA within 90 days of opening the bottle. • Your doctor should do certain blood tests while you are taking ERMEZA and may change your daily dose of ERMEZA as needed. Keep taking ERMEZA unless your doctor tells you to stop or to change your dose. It may take weeks before you notice your symptoms getting better.

Keep using this medicine even if you feel well. In case of overdose, get medical help or contact a live Poison Control expert at 1-800-222-1222. Advice is also available online at www.poison.org.

What are the possible side effects of ERMEZA? ERMEZA may cause serious side effects, including: • heart problems. You may expe… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

INSTRUCTIONS FOR USE ERMEZA™ [er-meh-zah] (levothyroxine sodium oral solution) Read this Instructions for Use before you start taking ERMEZA and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. • Keep ERMEZA and all medicines out of reach of children. • Be sure that you read, understand and follow these instructions carefully to ensure correct dosing of the oral solution. • Always check the expiration date of your ERMEZA before use.

Do not use if the expiration date has passed. • Throw away (discard) any unused ERMEZA after 90 days of first opening the bottle. • Store ERMEZA at room temperature between 68°F to 77°F (20°C to 25°C) with the oral syringes in the original carton. Important Information You Need to Know Before Taking ERMEZA. For oral use only (take by mouth).

Two ERMEZA syringes are provided in the carton (see Figure A): • 5 mL syringe for doses up to 5 mL. Each graduation mark represents 0.1 mL. Figure A shows a graduation mark of 4 mL as an example. • 10 mL syringe for doses over 5 mL.

Each graduation mark represents 0.2 mL. Figure A shows a graduation mark of 8 mL as an example. Do not wash the syringes in a dishwasher, use warm water only.

Step 1: Preparing the Dose • Hold the bottle firmly with 1 hand and then push down on the bottle cap and turn it counterclockwise to remove it. • Ensure the syringe plunger is pushed all the way into the barrel to remove any air from the syringe. • Place the oral syringe provided into the medicine within the bottle (See Figure B). • Pull back the plunger, ensuring the end remains in the medicine, until the graduation mark for the dose prescribed by your healthcare provider lines up with the top surface of the syringe barrel (See Figure B).

Figure B shows a dose of 3.7 mL as an example. • If you see any large air bubbles in the barrel of the syringe, hold the syringe over the bottle to remove them and repeat Step 1. Step 2: Taking ERMEZA • Place the end of the oral syringe into the corner of the mouth toward the inside cheek (See Figure C). • Slowly push the plunger down until the syringe is empty. • Replace cap onto bottle and screw in a clockwise direction until tight. Step 3: Cleaning and Storage • Pull plunger straight out of the oral syringe barrel (See Figure D).

Rinse the barrel and plunger with warm water and leave to air dry. • When dry, place the plunger back inside the oral syringe barrel and put back inside the carton supplied and store at room temperature between 68°F to 77°F (20°C to 25°C). For more information, call Mylan at 1-877-446-3679 (1-877-4-INFO-RX). © 2022 Viatris Inc. ERMEZA is a trademark of Mylan Pharmaceuticals Inc., a Viatris Company.

Manufactured for: Mylan Specialty L.P. Morgantown, WV 26505 U.S.A. Manufactured by: DPT Laboratories, Ltd.

San Antonio, TX 78215 U.S.A. This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Issued: 4/2022 141152-0422 IFU:LEVOOSN:R1 Instructions for Use Figure A Instructions for Use Figure B Instructions for Use Figure C Instructions for Use Figure D

📄 Package Label / Principal Display Panel 158 words ▾

PRINCIPAL DISPLAY PANEL – 150 mcg/5 mL NDC 49502-378-75 Rx only Ermeza™ (levothyroxine sodium) Oral Solution 150 mcg/5 mL (30 mcg/mL) For Oral Administration Only Please read the Instructions for Use before administering Ermeza. One 5 mL oral syringe and one 10 mL oral syringe provided. Store and dispense in original bottle.

75 mL Each 5 mL contains: Levothyroxine sodium, USP 150 mcg Usual Dosage: See accompanying prescribing information. Keep this and all medication out of the reach of children. Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] Protect from light.

Use within 90 days of opening the bottle. Manufactured for: Mylan Specialty L.P. Morgantown, WV 26505 U.S.A.

Manufactured by: DPT Laboratories, Ltd. San Antonio, TX 78215 U.S.A. Mylan.com ERMEZA is a trademark of Mylan Pharmaceuticals Inc., a Viatris Company. © 2022 Viatris Inc.

DPT:37875:1C:R3 117715-1222 Ermeza Oral Solution 150 mcg/5 mL Carton Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
310
Units reimbursed last 4 qtrs
26.6K
Gross reimbursed last 4 qtrs
$48.6K
Avg / prescription
$156.66
Avg / unit
$1.8249
Latest quarter Q1 2026
0Rx
Medicaid pays / mL
$1.8249
gross reimbursed
vs
NADAC / mL
$1.7224
acquisition cost
=
Spread
+$0.1025
+6% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
33% FFS 67% MCO
Fee-for-service · 102 Rx Managed care · 208 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 5,175 units · 26.4 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: 10,489 units · 80.9 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 3,129 units · 50.5 per 100k residents MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 2,734 units · 25.2 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 645 units · 14.1 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 4,441 units · 14.6 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
14.180.9
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Pennsylvania 80.9 /100k
2 Missouri 50.5 /100k
3 New York 26.4 /100k
4 North Carolina 25.2 /100k
5 Texas 14.6 /100k
6 Louisiana 14.1 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 bottle this page49502-0378-75 310 Rx · $48,566
1 bottle49502-0378-15 281 Rx · $84,218
Drug total (last 4 qtrs): 591 Rx · 73,629 units · $132,784 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)

Medicare Part D (outpatient prescription) spending for Ermeza — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Ermeza. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Total Part D spend
$37.6K
Claims incl. refills
144
Beneficiaries
54
Spend / beneficiary
$696.22
Spend / claim
$261.08
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Levothyroxine sodium — the ingredient across all brands.

Top reported reactions

Fatigue26,585
Nausea22,605
Headache19,408
Diarrhoea18,759
Dyspnoea16,717
Pain16,375
Dizziness15,848

Reporter sex

312,551 reports
Male · 19%
Female · 81%
Unknown · 0%

Serious outcomes

Death20,300
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 19,277 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) ✓ Available
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 bottle (49502-0378-15). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Viatris Specialty LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 49502-0345-73 · Viatris 49502-0401-09 · Viatris →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.