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THYQUIDITY Levothyroxine Sodium 100 ug/5mL Solution — NDC 82685-0360-01 package photo

THYQUIDITY Levothyroxine Sodium 100 ug/5mL Solution

by Oliva Therapeutics, LLC · 1 BOTTLE, GLASS in 1 CARTON (82685-360-01) / 100 mL in 1 BOTTLE, GLASS
NDC 82685-0360-01
🏷️ FDA NDC (as labeled) 82685-360-01 billing pads the product segment with a zero
This package
Contains100 mL in 1 bottle, glass Pack sizes2 compare ↓
Also priced by: Part D plans $1.51/unit — full pricing hub ↓
Also comes in: 2 bottles 82685-0360-02
Rx only Brand On market Non-controlled
🗂️ Data synced 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-0781-2026
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-0782-2026
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-0777-2026
Class II · Aug 6, 2026 — Subpotent Drug (ACCORD HEALTHCARE, INC.) · FDA recall D-0776-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 82685-360-01
Product NDC 82685-360
11-digit billing NDC 82685036001
NCPDP billing unit ML — per mL (volume)
RxCUI 2473276, 2473282
UNII 9J765S329G
UPC 0382685360014
Application # NDA214047
SPL Set ID 0c839877-50e4-455f-9b6c-462efb09cb96
Established class (EPC) l-Thyroxine
Chemical class Thyroxine
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-07-01
Route ORAL
Dosage form SOLUTION
Substance LEVOTHYROXINE SODIUM
GPI-14 28100010102023
GCN Seq No 061499
GCN 97287
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 THYQUIDITY 100 MCG/5 ML SOLN
FDB brand name Thyquidity
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 82685-360-01 — 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 → 82685-0360-01. 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.

🏭 Manufacturer & labeler

LabelerOliva Therapeutics, LLC
Application holderJEROME STEVENS PHARMACEUTICALS INC
FDA applicationNDA214047 (NDA)
Labeler code82685
First marketedJul 2025
Product typeHuman Prescription Drug
Portfolio11 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.

🩺 Clinical

Label name THYQUIDITY 100 MCG/5 ML SOLN 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
  • Your thyroid gland isn't making enough of a hormone called T4, which your whole body depends on to regulate your energy, metabolism, heart rate, and more. Levothyroxine is a precis...
  • What exactly is levothyroxine doing for me — why do I need to take it every day?
  • Timing really does make a difference with this medication. Food — especially high-fiber foods or anything soy-based — can block your gut from absorbing it properly. Taking it 30 to...
  • Why does it matter so much when I take it — can't I just take it with breakfast?
📖 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.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII CR6K9C2NHK
    A synthetic preservative derived from methylparaben. It prevents bacterial and fungal growth in medicines, extending shelf life and maintaining product safety during storage.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

5 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
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.

💲 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 Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $1.51 $150.76 / 100 ml
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Thyquidity 100 ug/5mLthis 82685-0360-01 Oliva 1 bottle — — FDA listed —
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

🏛️
2020
First FDA approval
Nov 2020
📍
2026
Currently FDA-listed
6 years listed
🛡️
2031
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 Aug 2031. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Nov 30, 2020 RLD RS ⏳ ~4.9 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 9050307 — drug product
2020 2022 2024 2026 2028 2030
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 9050307 ↗ Drug product — Aug 6, 2031
Common questions
Is there a generic version of THYQUIDITY 100 MCG/5 ML SOLN?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for THYQUIDITY 100 MCG/5 ML SOLN. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Aug 2031 — 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.

💊 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.
2 bottles82685-0360-02 1,379 Rx · $330,417
1 bottle this page82685-0360-01 No Medicaid data
Drug total (last 4 qtrs): 1,379 Rx · 230,505 units · $330,417 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 · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Thyquidity — 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 Thyquidity. 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.
Period
Total Part D spend
$98.9K
Claims incl. refills
375
Beneficiaries
180
Spend / beneficiary
$549.35
Spend / claim
$263.69
Trend by period
💵 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

Age at onset

Neonate282
Infant75
Child220
Adolescent179
Adult19,320
Elderly21,623

Reporter sex

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

Serious outcomes

Hospitalization90,712
Death20,300
Life-threatening10,774
Disabling9,272
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 18,046 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.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
82685-0360-01 You're viewing this 1 BOTTLE, GLASS in 1 CARTON (82685-360-01) / 100 mL in 1 BOTTLE, GLASS — — 2025-07-01 Active
82685-0360-02 2 BOTTLE, GLASS in 1 CARTON (82685-360-02) / 100 mL in 1 BOTTLE, GLASS $1.38 / mL $276.88 2025-07-01 Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 82685-0360-01?
NDC 82685-0360-01 is listed by the FDA — 1 bottle, glass in 1 carton / 100 ml in 1 bottle, glass.
What NDC number is used to bill for this package of THYQUIDITY Levothyroxine Sodium 100 ug/5mL Solution?
Bill NDC 82685-0360-01 — the 11-digit billing format is 82685036001. 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.

🧭 About this NDC listing & data coverage

Finished prescription product
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 ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
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) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
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 FDA registers it as 82685-360-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 82685-0360-01, written without dashes as 82685036001. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 82685-0360-01, the first segment (82685) is the labeler code FDA assigned to Oliva Therapeutics, LLC; the middle segment (0360) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Oliva Therapeutics, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 2 bottles (82685-0360-02). 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?
Oliva Therapeutics, 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. 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
🚨 Boxed Warning 149 words ▾

WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS Thyroid hormones, including THYQUIDITY, 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 THYQUIDITY, 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 181 words ▾

1 INDICATIONS AND USAGE Hypothyroidism THYQUIDITY is indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression THYQUIDITY is indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: THYQUIDITY 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 THYQUIDITY may induce hyperthyroidism [see Warnings and Precautions (5.4) ].

THYQUIDITY is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. THYQUIDITY is levothyroxine sodium (T4) indicated for: Hypothyroidism: As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. (1) Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.

(1) Limitations of Use: Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis

⏱️ Dosage and Administration ~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) Administer orally using syringe provided by the pharmacy (2.1) Evaluate the need for dose adjustments when regularly administering within one hour of certain foods that may affect THYQUIDITY absorption.

(2.1) Starting dose depends on a variety of factors, including age, body weight, cardiovascular status, and concomitant medical conditions (including pregnancy), concomitant medications, co-administered food, and the specific nature of the condition being treated. 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. (2.4)

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

Administer THYQUIDITY directly to the mouth using a calibrated oral syringe provided by the pharmacy. A household teaspoon or tablespoon is not an adequate measuring device.

2.2General Principles of Dosing The dose of THYQUIDITY for hypothyroidism or pituitary TSH suppression depends on a variety of factors including: the patient's age, body weight, cardiovascular status, concomitant medical conditions (including pregnancy), concomitant medications, co-administered food and the specific nature of the condition being treated [see Dosage and Administration (2.3) , Warnings and Precautions (5) , and Drug Interactions (7) ] . Dosing must be individualized to account for these factors and dose adjustments made based on periodic assessment of the patient's clinical response and laboratory parameters [see Dosage and Administration (2.4) ] .

The peak therapeutic effect of a given dose of THYQUIDITY may not be attained for 4 to 6 weeks.

2.3Dosing in Specific Patient Populations Primary Hypothyroidism in Adults and in Adolescents in Whom Growth and Puberty are Complete Start THYQUIDITY at the full replacement dose in otherwise healthy, non-elderly individuals who have been hypothyroid for only a short time (such as a few months). The average full replacement dose of THYQUIDITY is approximately 1.6 mcg per kg per day (for example: 100 to 125 mcg per day for a 70 kg adult). Adjust the dose by 12.5 to 25 mcg increments every 4 to 6 weeks until the patient is clinically euthyroid and the serum TSH returns to normal.

Doses greater than 200 mcg per day are seldom required. An inadequate response to daily doses of greater than 300 mcg per day is rare and may indicate poor compliance, malabsorption, drug interactions, or a combination of these factors. For elderly patients or patients with underlying cardiac disease, start with a dose of 12.5 to 25 mcg per day.

Increase the dose every 6 to 8 weeks, as needed, until the patient is clinically euthyroid and the serum TSH returns to normal. The full replacement dose of THYQUIDITY may be less than 1 mcg per kg per day in elderly patients. In patients with severe longstanding hypothyroidism, start with a dose of 12.5 to 25 mcg per day.

Adjust the dose in 12.5 to 25 mcg increments every 2 to 4 weeks until the patient is clinically euthyroid and the serum TSH level is normalized. Secondary or Tertiary Hypothyroidism Start THYQUIDITY at the full replacement dose in otherwise healthy, non-elderly individuals. Start with a lower dose in elderly patients, patients with underlying cardi…

💊 Dosage Forms and Strengths 56 words ▾

3 DOSAGE FORMS AND STRENGTHS Oral Solution: 100 mcg per 5 mL (20 mcg per mL) clear, colorless to nearly colorless solution in 100 mL bottles THYQUIDITY is to be used with a calibrated oral syringe provided by the pharmacy. Oral Solution: 100 mcg per 5 mL (20 mcg per mL) in 100 mL bottles (3)

⛔ Contraindications 22 words ▾

4 CONTRAINDICATIONS THYQUIDITY is contraindicated in patients with: Uncorrected adrenal insufficiency [see Warnings and Precautions (5.3) ] . Uncorrected adrenal insufficiency. (4)

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Cardiac adverse reactions in the elderly and in patients with underlying cardiovascular disease: Initiate THYQUIDITY at less than the full replacement dose because of the increased risk of cardiac adverse reactions, including atrial fibrillation. ( 2.3 , 5.1 , 8.5 ) Myxedema coma: Do not use oral thyroid hormone drug products to treat myxedema coma. (5.2) Acute adrenal crisis in patients with concomitant adrenal insufficiency: Treat with replacement glucocorticoids prior to initiation of THYQUIDITY treatment.

(5.3) Prevention of hyperthyroidism or incomplete treatment of hypothyroidism: Proper dose titration and careful monitoring is critical to prevent the persistence of hypothyroidism or the development of hyperthyroidism. (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)

5.1Cardiac 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 THYQUIDITY 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 THYQUIDITY therapy. Monitor patients receiving concomitant THYQUIDITY and sympathomimetic agents for signs and symptoms of coronary insufficiency. If cardiac symptoms develop or worsen, reduce the THYQUIDITY dose or withhold for one week and restart at a lower dose.

5.2Myxedema 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.

5.3Acute 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 THYQUIDITY [see Contraindications (4) ].

5.4Prevention of Hyperthyroidism or Incomplete Treatment of Hypothyroidism THYQUIDITY has a narrow therapeutic index. Over- or undertreatment with THYQUIDITY may have negative effects on growth and development, cardiovascular function, bone metabolism, reproductive function, cognitive function, emotional state, gastrointestinal function, and glucose and lipid metabolism [see Use in Specific Populations - Pediatric Use (8.4) ] . Titrate the dose of THYQUIDITY carefully and monitor response to titration to avoid these effects [see Dosage and Administration (2.4) ] .

Monitor for the presence of drug or food interactions when using THYQUIDITY and adjust the dose as necessary [see Drug Interactions (7.9) and Clinical Pharmacology (12.3) ] .

5.5Worsening of Diabetic Control Addition of levothyroxine therapy in patients with diabetes mellitus may worsen glycemic control and result in increased antidiabetic agent or insulin requir…

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS Adverse reactions associated with THYQUIDITY 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 Children Pseudotumor cerebri and slipped capital femoral epiphysis have been reported in children receiving levothyroxine therapy. Overtreatment may result in craniosynostosis in infants and premature closure of the epiphyses in children 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 THYQUIDITY 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 Oliva Therapeutics, LLC at 1-877-200-6088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions ~2 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 THYQUIDITY. (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 THYQUIDITY (see Tables 2-5 below). Table 2. Drugs That May Decrease T4 Absorption (Hypothyroidism) Potential impact: Concurrent use may reduce the efficacy of THYQUIDITY by binding and delaying or preventing absorption, potentially resulting in hypothyroidism.

Drug or Drug Class Effect Calcium Carbonate Ferrous Sulfate Calcium carbonate may form an insoluble chelate with levothyroxine, and ferrous sulfate likely forms a ferric- thyroxine complex. Administer THYQUIDITY at least 4 hours apart from these agents. Orlistat Monitor patients treated concomitantly with orlistat and THYQUIDITY for changes in thyroid function.

Bile Acid Sequestrants -Colesevelam -Cholestyramine -Colestipol Ion Exchange Resins -Kayexalate -Sevelamer Bile acid sequestrants and ion exchange resins are known to decrease levothyroxine absorption. Administer THYQUIDITY 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 3.

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 THYQUIDITY 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 4.

Drugs That May Alter Hepatic Metabolism of T4 (Hypothyroidism) Potential impact: Stimulation of hepatic microsomal drug-metabolizing enzyme activity may cause increased hepatic degradation of levothyroxine, resulting in increased THYQUIDITY 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…

👥 Use in Specific Populations ~3 min read ▾

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

8.1Pregnancy Risk Summary Prolonged experience with levothyroxine use in pregnant women, including data from post-marketing studies, to maintain a euthyroid state have not reported increased rates of major birth defects, miscarriages, or adverse maternal or fetal outcomes . There are risks to the mother and fetus associated with untreated hypothyroidism in pregnancy. Since TSH levels may increase during pregnancy, TSH should be monitored and THYQUIDITY dosage adjusted during pregnancy ( see Clinical Considerations ) .

There are no animal studies conducted with levothyroxine during pregnancy. THYQUIDITY 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 THYQUIDITY requirements. Serum TSH levels should be monitored and the THYQUIDITY dosage adjusted during pregnancy to maintain TSH within normal trimester specific ranges.

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

8.2Lactation Risk Summary Limited published studies report that levothyroxine is present in human milk. 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 THYQUIDITY and any potential adverse effects on the breastfed infant from THYQUIDITY or from the underlying maternal condition.

8.4Pediatric Use Safety and effectiveness of THYQUIDITY has been established for the treatment of congenital hypothyroidism and acquired hypothyroidism in pediatric patients down to birth [see Adverse Reactions (6) ]. Glycerol 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 glycerol-induced gastrointestinal irritation.

Closely monitor patients from birth to 3 months of age receiving THYQUIDITY for signs and symptoms of gastrointestinal irritation. Congenital Hypothyroidism [see Dosage and Administration ( 2.3 , 2.4 )] Rapid restoration of normal serum T4 concentrations is essential for preventing the adverse effects of congenital hypothyroidism on intellectual development as well as on overall physical growth and maturation. Therefore, initiate THYQUIDITY therapy immediately upon diagnosis.

Levothyroxine is generally continued for life in these patients. Closely monitor patients during the first 2 weeks of THYQUIDITY therapy for cardiac overload, arrhythmias, and aspiration from avid suckling. Closely monitor patients to avoid undertreatment or overtreatment.

Undertreatment may have deleterious effects on intellectual development and linear g…

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Prolonged experience with levothyroxine use in pregnant women, including data from post-marketing studies, to maintain a euthyroid state have not reported increased rates of major birth defects, miscarriages, or adverse maternal or fetal outcomes . There are risks to the mother and fetus associated with untreated hypothyroidism in pregnancy. Since TSH levels may increase during pregnancy, TSH should be monitored and THYQUIDITY dosage adjusted during pregnancy ( see Clinical Considerations ) .

There are no animal studies conducted with levothyroxine during pregnancy. THYQUIDITY 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 THYQUIDITY requirements. Serum TSH levels should be monitored and the THYQUIDITY dosage adjusted during pregnancy to maintain TSH within normal trimester specific ranges.

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

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use Safety and effectiveness of THYQUIDITY has been established for the treatment of congenital hypothyroidism and acquired hypothyroidism in pediatric patients down to birth [see Adverse Reactions (6) ]. Glycerol 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 glycerol-induced gastrointestinal irritation.

Closely monitor patients from birth to 3 months of age receiving THYQUIDITY for signs and symptoms of gastrointestinal irritation. Congenital Hypothyroidism [see Dosage and Administration ( 2.3 , 2.4 )] Rapid restoration of normal serum T4 concentrations is essential for preventing the adverse effects of congenital hypothyroidism on intellectual development as well as on overall physical growth and maturation. Therefore, initiate THYQUIDITY therapy immediately upon diagnosis.

Levothyroxine is generally continued for life in these patients. Closely monitor patients during the first 2 weeks of THYQUIDITY therapy for cardiac overload, arrhythmias, and aspiration from avid suckling. Closely monitor patients to avoid undertreatment or overtreatment.

Undertreatment may have deleterious effects on intellectual development and linear growth. Overtreatment is associated with craniosynostosis in infants, may adversely affect the tempo of brain maturation, and may accelerate the bone age and result in premature epiphyseal closure and compromised adult stature. Acquired Hypothyroidism in Pediatric Patients Closely monitor patients to avoid undertreatment and overtreatment.

Undertreatment may result in poor school performance due to impaired concentration and slowed mentation and in reduced adult height. Overtreatment may accelerate the bone age and result in premature epiphyseal closure and compromised adult stature. Treated children may manifest a period of catch-up growth, which may be adequate in some cases to normalize adult height.

In children with severe or prolonged hypothyroidism, catch-up growth may not be adequate to normalize adult height.

🧓 Geriatric Use 59 words ▾

8.5Geriatric Use Because of the increased prevalence of cardiovascular disease among the elderly, initiate THYQUIDITY at less than the full replacement dose [see W arnings and Precautions (5.1) and Dosage and Administration (2.3) ] . Atrial arrhythmias can occur in elderly patients. Atrial fibrillation is the most common of the arrhythmias observed with levothyroxine overtreatment in the elderly.

🆘 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 THYQUIDITY dose or discontinue temporarily if signs or symptoms of overdosage occur.

Initiate appropriate supportive treatment as dictated by the patient's medical status. For current information on the management of poisoning or overdosage, contact the National Poison Control Center at 1-800-222-1222 or www.poison.org.

🧬 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 THYQUIDITY 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 6). 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 6.

Pharmacokinetic Parameters of Thyroid Hormones in Euthyroid Patients Hormone Ratio in Thyroglobulin Biologic Potency Half-Life (days) Protein Binding (%) a Levothyroxine (T4) 10 - 20 1 6-7 b

99.96Liothyronine (T3) 1 4 ≤ 2 99.5 a Includes TBG, TBPA, and TBA b 3 to 4 days in hyperthyroidism, 9 to 10 days in hypothyroidism

🧬 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 103 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING THYQUIDITY (levothyroxine sodium) oral solution, 100 mcg per 5 mL (20 mcg per mL) is a clear, colorless to nearly colorless solution supplied in a 100 mL amber glass bottle with a child-resistant closure as follows: NDC 82685-360-01: 1 x 100 mL bottle NDC 82685-360-02: 2 x 100 mL bottles (NDC 82685-360-01) The pharmacy will provide a calibrated oral syringe to accurately measure the prescribed dose. Storage Conditions Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

Protect from light. Store and dispense in original bottle. Use within 8 weeks of opening the bottle.

📋 Description 104 words ▾

11 DESCRIPTION THYQUIDITY (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 • x H 2 O, molecular weight of 798.85 (anhydrous), and structural formula as shown: THYQUIDITY oral solution is supplied in the following strength: 100 mcg per 5 mL (20 mcg per mL).

THYQUIDITY oral solution contains the inactive ingredients citric acid monohydrate, glycerin, methylparaben sodium, sodium hydroxide and purified water. Structure

💬 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 THYQUIDITY: Dosing and Administration Instruct patients to take THYQUIDITY only as directed by their healthcare provider. Instruct patients to take THYQUIDITY once daily, preferably on an empty stomach, one-half to one hour before breakfast. Instruct patients to always use a calibrated oral syringe provided by the pharmacy when administering THYQUIDITY to ensure that the dose is measured and administered accurately.

Inform patients that agents such as iron and calcium supplements and antacids can decrease the absorption of levothyroxine. Instruct patients not to take THYQUIDITY 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 THYQUIDITY.

Important Information Inform patients that it may take several weeks before they notice an improvement in symptoms. Inform patients that the levothyroxine in THYQUIDITY 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 THYQUIDITY 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 THYQUIDITY.

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 THYQUIDITY 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 THYQUIDITY therapy, but this is usually temporary.

Distributed by: Oliva Therapeutics, LLC Ridgewood, NJ 07450 For more information go to www.thyquidity.com Thyquidity is a registered trademark of Jerome Stevens Pharmaceuticals, Inc. Rev. 04/25 THY-PI-01

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