HomeNDC LookupIngredientsLevothyroxine Liothyronine › 42192-0331-01
NP Thyroid 90 LEVOTHYROXINE, LIOTHYRONINE 57 ug; 13.5 ug Tablet, 100-count — NDC 42192-0331-01 package photo

NP Thyroid 90 LEVOTHYROXINE, LIOTHYRONINE 57 ug; 13.5 ug Tablet, 100-count

by Acella Pharmaceuticals, LLC · 100 TABLET in 1 BOTTLE (42192-331-01)
NDC 42192-0331-01
🏷️ FDA NDC (as labeled) 42192-331-01 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$1.00 NADAC Per package$100.22 / 100 tablets Pack sizes4 compare ↓
Also priced by: Medicaid pays $1.26/unit — full pricing hub ↓
Rx only On market Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 42192-331-01
Product NDC 42192-331
11-digit billing NDC 42192033101
NCPDP billing unit EA — each (per item)
UNII 06LU7C9H1V, Q51BO43MG4
UPC 0342192329102, 0342192330108, 0342192327016, 0342192328013
SPL Set ID a3ff93ad-86ed-4324-ae86-7e7ed3a49db8
Established class (EPC) l-Triiodothyronine; l-Thyroxine
Chemical class Triiodothyronine; Thyroxine
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-02-03
Route ORAL
Dosage form TABLET
Substance LEVOTHYROXINE; LIOTHYRONINE
GPI-14 28100050000320
GPI class NP Thyroid
GCN Seq No 065424
GCN 27385
HICL code 002846
Ingredient (HICL) Thyroid,Pork
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 NP THYROID 90 MG TABLET
FDB brand name Np Thyroid
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 42192-331-01 — 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 → 42192-0331-01. 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.

🏭 Manufacturer & labeler

LabelerAcella Pharmaceuticals, LLC
Labeler code42192
First marketedFeb 2011
Product typeHuman Prescription Drug
Portfolio36 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 NP THYROID 90 MG TABLET Ingredient Thyroid,Pork
📖 What it is MedlinePlus · NLM

Thyroid is used to treat the symptoms of hypothyroidism (a condition where the thyroid gland does not produce enough thyroid hormone). Symptoms of hypothyroidism include lack of energy, depression, constipation, weight gain, hair loss, dry skin, dry coarse hair, muscle cramps, decreased concentration, aches and pains, swelling of the legs, and increased sensitivity to cold. Thyroid is also used to treat goiter (enlarged thyroid gland). Thyroid is in a class of medications called thyroid agents. It works by supplying the thyroid hormone normally produced by the body.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Desiccated thyroid is made from dried pig (porcine) thyroid glands and naturally contains both T4 and T3 — the two main thyroid hormones your body makes. Synthetic options like lev...
  • What exactly is desiccated thyroid, and is it the same as synthetic thyroid hormone?
  • No — and this is really important. If your thyroid is working normally, taking thyroid hormone will not cause meaningful weight loss. Worse, taking it in higher doses to try to los...
  • Can I use thyroid tablets to lose weight?
📖 Read our full Thyroid 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.

💊 What it looks like

Color brown
ShapeRound
ImprintAP;328
Size8 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 776XM7047L
    Calcium stearate is a white powder derived from stearic acid and calcium. It works as a lubricant and glidant to help the medicine flow smoothly during manufacturing and prevent ingredients from sticking to equipment.
  • UNII LX22YL083G
    A simple sugar derived from corn or other sources. It acts as a filler to give the medicine bulk and volume, and as a sweetener to improve taste in oral medications.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.

3 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 DailyMedingredient 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 eaPer package
Retail pharmacies payNADAC · weekly $1.002 $100.22 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $1.26 $125.67 / 100 tablets
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $1.136 $1.002
▼ Down 4% over the last 24 months.
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
NP Thyroid 90 57 ug/1; 13.5 ugthis 42192-0331-01 Acella 100 tablets $1.002 Availability likely
Thyroid 90 mg 62559-0743-01 ANI 100 tablets $1.002 Availability likely
Thyroid 90 mg 69680-0168-00 Vitruvias 100 tablets $1.002 Availability likely
EvexiTHROID 57 ug/1; 13.5 ug 73352-0698-10 Trifluent 100 tablets $1.002 Availability likely
Niva Thyroid 90 mg 75834-0313-01 Nivagen 100 tablets $1.002 Availability likely
Amerithroid 90 mg 82685-0344-01 Oliva 100 tablets $1.002 Availability likely
Armour Thyroid 90 mg 00456-0460-01 Allergan, 100 tablets $1.765 Availability likely +76%
NP Thyroid 57 ug/1; 13.5 ug 17224-0504-30 Calvin 30 tablets FDA listed
Armour Thyroid 90 mg 50090-1692-00 A-S 100 tablets FDA listed
Np Thyroid 90 57 ug/1; 13.5 ug 50090-5229-00 A-S 90 tablets FDA listed
RenThyroid 57 ug/1; 13.5 ug 64950-0173-01 Genus 100 tablets FDA listed
Niva Thyroid 90 mg 71335-2801-01 Bryant 30 tablets FDA listed
NP Thyroid 90 57 ug/1; 13.5 ug 76420-0569-01 Asclemed 100 tablets FDA listed
Thyroid 90 mg 79739-7373-01 LGM 100 tablets Discontinued
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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

🏛️
2011
On the market since
Feb 2011
📍
2026
Currently FDA-listed
15 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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 & 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 42192-0331-01, 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 – Q4 2025 · 4 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
16.2K
Units reimbursed last 4 qtrs
718.5K
Gross reimbursed last 4 qtrs
$902.9K
Avg / prescription
$55.63
Avg / unit
$1.2567
Latest quarter Q4 2025
3.7KRx
Medicaid pays / ea
$1.2567
gross reimbursed
vs
NADAC / ea
$1.0022
acquisition cost
=
Spread
+$0.2545
+25% vs cost
What Medicaid paid per ea (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
30% FFS 70% MCO
Fee-for-service · 4,792 Rx Managed care · 11,439 Rx
State Medicaid map
Alaska: 8,641 units · 1,179 per 100k residents AK Maine: 435 units · 31.2 per 100k residents ME Washington: 54,432 units · 697 per 100k residents WA Idaho: 24,083 units · 1,226 per 100k residents ID Montana: 11,547 units · 1,020 per 100k residents MT North Dakota: 752 units · 96.0 per 100k residents ND Minnesota: 8,704 units · 152 per 100k residents MN Wisconsin: 7,829 units · 132 per 100k residents WI Michigan: 26,841 units · 267 per 100k residents MI New York: 27,590 units · 141 per 100k residents NY Vermont: 4,386 units · 678 per 100k residents VT New Hampshire: 1,428 units · 102 per 100k residents NH Oregon: 34,646 units · 818 per 100k residents OR Nevada: 6,229 units · 195 per 100k residents NV Wyoming: 3,390 units · 580 per 100k residents WY South Dakota: 1,884 units · 205 per 100k residents SD Iowa: 6,436 units · 201 per 100k residents IA Illinois: 16,134 units · 129 per 100k residents IL Indiana: 13,384 units · 195 per 100k residents IN Ohio: 30,195 units · 256 per 100k residents OH Pennsylvania: 17,048 units · 132 per 100k residents PA New Jersey: 3,594 units · 38.7 per 100k residents NJ Massachusetts: 3,039 units · 43.4 per 100k residents MA California: no data reported CA Utah: 17,315 units · 507 per 100k residents UT Colorado: 55,802 units · 949 per 100k residents CO Nebraska: no data reported NE Missouri: 32,138 units · 519 per 100k residents MO Kentucky: 25,410 units · 561 per 100k residents KY West Virginia: 10,760 units · 608 per 100k residents WV Virginia: 12,580 units · 144 per 100k residents VA Maryland: 3,685 units · 59.6 per 100k residents MD Connecticut: 6,587 units · 182 per 100k residents CT Rhode Island: 2,080 units · 190 per 100k residents RI Arizona: 52,347 units · 704 per 100k residents AZ New Mexico: 59,985 units · 2,838 per 100k residents NM Kansas: 2,145 units · 73.0 per 100k residents KS Arkansas: 3,865 units · 126 per 100k residents AR Tennessee: 5,918 units · 83.0 per 100k residents TN North Carolina: 23,874 units · 220 per 100k residents NC South Carolina: 6,640 units · 124 per 100k residents SC Delaware: no data reported DE Oklahoma: 8,183 units · 202 per 100k residents OK Louisiana: 24,655 units · 539 per 100k residents LA Mississippi: 2,610 units · 88.8 per 100k residents MS Alabama: no data reported AL Georgia: 4,367 units · 39.6 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 29,495 units · 96.7 per 100k residents TX Florida: 15,384 units · 68.0 per 100k residents FL
Units reimbursed · per 100k residents
31.22,838
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 New Mexico 2,838 /100k
2 Idaho 1,226 /100k
3 Alaska 1,179 /100k
4 Montana 1,020 /100k
5 Colorado 949 /100k
6 Oregon 818 /100k
7 Arizona 704 /100k
8 Washington 697 /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.
100 tablets this page42192-0331-01 16,231 Rx · $902,870
30 tablets42192-0331-30 14 Rx · $883
1000 tablets42192-0331-10 No Medicaid data
90 tablets42192-0331-90 No Medicaid data
Drug total (last 4 qtrs): 16,245 Rx · 719,192 units · $903,752 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

🔬 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 NP Thyroid 90 (this brand).

Top reported reactions

Fatigue4
Asthenia3
Dizziness3
Arthralgia2
Disorientation2
Dysarthria2
Feeling Abnormal2

Age at onset

Elderly1

Reporter sex

15 reports
Male · 29%
Female · 71%

Serious outcomes

Hospitalization4
Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1 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
42192-0331-01 You're viewing this 100 TABLET in 1 BOTTLE (42192-331-01) $1.00 / ea $100.22 2011-02-03 Active
42192-0331-10 1000 TABLET in 1 BOTTLE (42192-331-10) $1.00 / ea $1,002.24 2025-03-03 Active
42192-0331-30 30 TABLET in 1 BOTTLE (42192-331-30) $1.00 / ea $30.07 2025-03-03 Active
42192-0331-90 90 TABLET in 1 BOTTLE (42192-331-90) $1.00 / ea $90.20 2025-12-01 Active

You're viewing one of 4 pack sizes for this product.

This pack has the lowest per-ea cost of the 4 priced pack sizes ($1.00 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 42192-0331-01?
NDC 42192-0331-01 is a 100-count package — 100 tablet in 1 bottle.
What is the difference between NDC 42192-0331-01 and NDC 42192-0331-30?
Both are NP Thyroid 90 LEVOTHYROXINE, LIOTHYRONINE 57 ug; 13.5 ug Tablet — the drug itself is identical. NDC 42192-0331-01 is the 100-count package, while NDC 42192-0331-30 is the 30 tablets package.
What NDC number is used to bill for this package of NP Thyroid 90 LEVOTHYROXINE, LIOTHYRONINE 57 ug; 13.5 ug Tablet?
Bill NDC 42192-0331-01 — the 11-digit billing format is 42192033101. 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 Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

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) ✓ Available
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
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 42192-331-01, 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: 42192-0331-01, written without dashes as 42192033101. 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 42192-0331-01, the first segment (42192) is the labeler code FDA assigned to Acella Pharmaceuticals, LLC; the middle segment (0331) 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 Acella Pharmaceuticals, 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 3 other package presentations of this same product, including 30 tablets (42192-0331-30), 90 tablets (42192-0331-90), 1000 tablets (42192-0331-10). 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?
Acella Pharmaceuticals, 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 63 words

Drugs with thyroid hormone activity, alone or together with other therapeutic agents, have been used for the treatment of obesity. 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.

🎯 Indications and Usage 129 words

INDICATIONS AND USAGE NP Thyroid ® tablets (thyroid tablets, USP) are indicated: 1. As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism (See WARNINGS).

2. As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto’s), multinodular goiter, and in the management of thyroid cancer.

⏱️ Dosage and Administration ~3 min read

DOSAGE AND ADMINISTRATION The dosage of thyroid hormones is determined by the indication and must in every case be individualized according to patient response and laboratory findings. Biotin supplementation may interfere with immunoassays for TSH, T 4 , and T 3 , resulting in erroneous thyroid hormone test results. Inquire whether patients are taking biotin or biotin-containing supplements.

If so, advise them to stop biotin supplementation at least 2 days before assessing TSH and/or T 4 levels (see PRECAUTIONS). Thyroid hormones are given orally. In acute, emergency conditions, injectable levothyroxine sodium may be given intravenously when oral administration is not feasible or desirable, as in the treatment of myxedema coma, or during total parenteral nutrition.

Intramuscular administration is not advisable because of reported poor absorption. Hypothyroidism - Therapy is usually instituted using low doses, with increments which depend on the cardiovascular status of the patient. The usual starting dose is 30 mg NP Thyroid®, with increments of 15 mg every 2 to 3 weeks.

A lower starting dosage, 15 mg/day, is recommended in patients with long standing myxedema, particularly if cardiovascular impairment is suspected, in which case extreme caution is recommended. The appearance of angina is an indication for a reduction in dosage. Most patients require 60 to 120 mg/day.

Failure to respond to doses of 180 mg suggests lack of compliance or malabsorption. Maintenance dosages 60 to 120 mg/day usually result in normal serum levothyroxine (T 4 ) and triiodothyronine (T 3 ) levels. Adequate therapy usually results in normal TSH and T 4 levels after 2 to 3 weeks of therapy.

Readjustment of thyroid hormone dosage should be made within the first four weeks of therapy, after proper clinical and laboratory evaluations, including serum levels of T 4 , bound and free, and TSH. T 3 may be used in preference to levothyroxine (T 4 ) during radio-isotope scanning procedures, since induction of hypothyroidism in those cases is more abrupt and can be of shorter duration. It may also be preferred when impairment of peripheral conversion of T 4 and T 3 is suspected.

Myxedema Coma - Myxedema coma is usually precipitated in the hypothyroid patient of long-standing by intercurrent illness or drugs such as sedatives and anesthetics and should be considered a medical emergency. Therapy should be directed at the correction of electrolyte disturbances and possible infection besides the administration of thyroid hormones. Corticosteroids should be administered routinely.

T 4 and T 3 may be administered via a nasogastric tube but the preferred route of administration of both hormones is intravenous. Levothyroxine sodium (T 4 ) is given at starting dose of 400 mcg (100 mcg/mL) given rapidly, and is usually well tolerated, even in the elderly. This initial dose is followed by daily supplements of 100 to 200 mcg given intravenously.

Normal T 4 levels are achieved in 24 hours followed in 3 days by threefold elevation of T 3 . Oral therapy with thyroid hormone would be resumed as soon as the clinical situation has been stabilized and the patient is able to take oral medication. Thyroid Cancer - Exogenous thyroid hormone may produce regression of metastases from follicular and papillary carcinoma of the thyroid and is used as ancillary therapy of these conditions with radioactive iodine.

TSH should be suppressed to low or undetectable levels. Therefore, larger amounts of thyroid hormone than those used for replacement therapy are required. Medullary carcinoma of the thyroid is usually unresponsive to this therapy.

Thyroid Suppression Therapy - Administration of thyroid hormone in doses higher than those produced physiologically by the gland results in suppression of the production of endogenous hormone. This is the basis for the thyroid suppression test and is used as an aid in the diagnosis of patients with signs of mild hyperthyroidism in whom base line laborator…

Contraindications 49 words

CONTRAINDICATIONS Thyroid hormone preparations are generally contraindicated in patients with diagnosed but as yet uncorrected adrenal cortical insufficiency, untreated thyrotoxicosis, and apparent hypersensitivity to any of their active or extraneous constituents. There is no well-documented evidence from the literature, however, of true allergic or idiosyncratic reactions to thyroid hormone.

⚠️ Warnings 109 words

WARNINGS Drugs with thyroid hormone activity, alone or together with other therapeutic agents, have been used for the treatment of obesity. 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.

The use of thyroid hormones in the therapy of obesity, alone or combined with other drugs, is unjustified and has been shown to be ineffective. Neither is their use justified for the treatment of male or female infertility unless this condition is accompanied by hypothyroidism.

🤒 Adverse Reactions 25 words

ADVERSE REACTIONS Adverse reactions other than those indicative of hyperthyroidism because of therapeutic overdosage, either initially or during the maintenance period, are rare (See OVERDOSAGE).

🔄 Drug Interactions ~1 min read

Drug Interactions Oral Anticoagulants — Thyroid hormones appear to increase catabolism of vitamin K-dependent clotting factors. If oral anticoagulants are also being given, compensatory increases in clotting factor synthesis are impaired. Patients stabilized on oral anticoagulants who are found to require thyroid replacement therapy should be watched very closely when thyroid is started.

If a patient is truly hypothyroid, it is likely that a reduction in anticoagulant dosage will be required. No special precautions appear to be necessary when oral anticoagulant therapy is begun in a patient already stabilized on maintenance thyroid replacement therapy. Insulin or Oral Hypoglycemics — Initiating thyroid replacement therapy may cause increases in insulin or oral hypoglycemic requirements.

The effects seen are poorly understood and depend upon a variety of factors such as dose and type of thyroid preparations and endocrine status of the patient. Patients receiving insulin or oral hypoglycemics should be closely watched during initiation of thyroid replacement therapy. Cholestyramine or Colestipol - Cholestyramine or colestipol binds both T 4 and T 3 in the intestine, thus impairing absorption of these thyroid hormones.

In vitro studies indicate that the binding is not easily removed. Therefore, four to five hours should elapse between administration of cholestyramine and thyroid hormones. Estrogen, Oral Contraceptives — Estrogens tend to increase serum thyroxine-binding globulin (TBg).

In a patient with a nonfunctioning thyroid gland who is receiving thyroid replacement therapy, free levothyroxine may be decreased when estrogens are started thus increasing thyroid requirements. However, if the patient’s thyroid gland has sufficient function, the decreased free levothyroxine will result in a compensatory increase in levothyroxine output by the thyroid. Therefore, patients without a functioning thyroid gland who are on thyroid replacement therapy may need to increase their thyroid dose if estrogens or estrogen-containing oral contraceptives are given.

🔄 Drug / Laboratory Test Interactions ~1 min read

Drug/Laboratory Test Interactions — The following drugs or moieties are known to interfere with laboratory tests performed in patients on thyroid hormone therapy: androgens, corticosteroids, estrogens, oral contraceptives containing estrogens, iodine-containing preparations, and the numerous preparations containing salicylates. 1. Changes in TBg concentration should be taken into consideration in the interpretation of T 4 and T 3 values.

In such cases, the unbound (free) hormone should be measured. Pregnancy, estrogens, and estrogen-containing oral contraceptives increase TBg concentrations. TBg may also be increased during infectious hepatitis.

Decreases in TBg concentrations are observed in nephrosis, acromegaly, and after androgen or corticosteroid therapy. Familial hyper- or hypothyroxine-binding-globulinemias have been described. The incidence of TBg deficiency approximates 1 in 9,000.

The binding of levothyroxine by TBPA is inhibited by salicylates. 2. Biotin supplementation is known to interfere with thyroid hormone immunoassays that are based on a biotin and streptavidin interaction, which may result in erroneous thyroid hormone test results.

Stop biotin and biotin-containing supplements for at least 2 days prior to thyroid testing. 3. Medicinal or dietary iodine interferes with all in vivo tests of radio-iodine uptake, producing low uptakes which may not be relative of a true decrease in hormone synthesis.

4. The persistence of clinical and laboratory evidence of hypothyroidism in spite of adequate dosage replacement indicates either poor patient compliance, poor absorption, excessive fecal loss, or inactivity of the preparation. Intracellular resistance to thyroid hormone is quite rare.

🤰 Pregnancy 50 words

Pregnancy — Thyroid hormones do not readily cross the placental barrier. The clinical experience to date does not indicate any adverse effect on fetuses when thyroid hormones are administered to pregnant women. On the basis of current knowledge, thyroid replacement therapy to hypothyroid women should not be discontinued during pregnancy.

🧒 Pediatric Use 125 words

Pediatric Use — Pregnant mothers provide little or no thyroid hormone to the fetus. The incidence of congenital hypothyroidism is relatively high (1:4,000) and the hypothyroid fetus would not derive any benefit from the small amounts of hormone crossing the placental barrier. Routine determinations of serum T 4 and/or TSH is strongly advised in neonates in view of the deleterious effects of thyroid deficiency on growth and development.

Treatment should be initiated immediately upon diagnosis, and maintained for life, unless transient hypothyroidism is suspected; in which case, therapy may be interrupted for 2 to 8 weeks after the age of 3 years to reassess the condition. Cessation of therapy is justified in patients who have maintained a normal TSH during those 2 to 8 weeks.

🆘 Overdosage ~1 min read

OVERDOSAGE Signs and Symptoms - Excessive doses of thyroid result in a hypermetabolic state resembling in every respect the condition of endogenous origin. The condition may be self-induced. Treatment of Overdosage - Dosage should be reduced or therapy temporarily discontinued if signs and symptoms of overdosage appear.

Treatment may be reinstituted at a lower dosage. In normal individuals, normal hypothalamic-pituitary-thyroid axis function is restored in 6 to 8 weeks after thyroid suppression. Treatment of acute massive thyroid hormone overdosage is aimed at reducing gastrointestinal absorption of the drugs and counteracting central and peripheral effects, mainly those of increased sympathetic activity.

Vomiting may be induced initially if further gastrointestinal absorption can reasonably be prevented and barring contraindications such as coma, convulsions, or loss of the gagging reflex. Treatment is symptomatic and supportive. Oxygen may be administered and ventilation maintained.

Cardiac glycosides may be indicated if congestive heart failure develops. Measures to control fever, hypoglycemia, or fluid loss should be instituted if needed. Antiadrenergic agents, particularly propranolol, have been used advantageously in the treatment of increased sympathetic activity.

Propranolol may be administered intravenously at a dosage of 1 to 3 mg, over a 10-minute period or orally, 80 to 160 mg/day, initially, especially when no contraindications exist for its use. Other adjunctive measures may include administration of cholestyramine to interfere with thyroxine absorption, and glucocorticoids to inhibit conversions of T 4 to T 3 .

🧬 Clinical Pharmacology ~1 min read

CLINICAL PHARMACOLOGY The steps in the synthesis of the thyroid hormones are controlled by thyrotropin (Thyroid Stimulating Hormone, TSH) secreted by the anterior pituitary. This hormone’s secretion is in turn controlled by a feedback mechanism effected by the thyroid hormones themselves and by thyrotropin releasing hormone (TRH), a tripeptide of hypothalamic origin. Endogenous thyroid hormone secretion is suppressed when exogenous thyroid hormones are administered to euthyroid individuals in excess of the normal gland’s secretion.

The mechanisms by which thyroid hormones exert their physiologic action are not well understood. These hormones enhance oxygen consumption by most tissues of the body, increase the basal metabolic rate, and the metabolism of carbohydrates, lipids, and proteins. Thus, they exert a profound influence on every organ system in the body and are of particular importance in the development of the central nervous system.

The normal thyroid gland contains approximately 200 mcg of levothyroxine (T 4 ) per gram of gland, and 15 mcg of liothyronine (T 3 ) per gram. The ratio of these two hormones in the circulation does not represent the ratio in the thyroid gland, since about 80 % of peripheral liothyronine (T 3 ) comes from monodeiodination of levothyroxine. Peripheral monodeiodination of levothyroxine at the 5 position (inner ring) also results in the formation of reverse liothyronine (T 3 ), which is calorigenically inactive.

Liothyronine (T 3 ) levels are low in the fetus and newborn, in old age, in chronic caloric deprivation, hepatic cirrhosis, renal failure, surgical stress, and chronic illnesses representing what has been called the “T 3 thyronine syndrome.”

📦 How Supplied / Storage and Handling ~1 min read

HOW SUPPLIED NP Thyroid ® tablets (thyroid tablets, USP) are available as: 15 mg (1/4 gr) NDC 42192-327-30 in 30-count bottle NDC 42192-327-90 in 90-count bottle NDC 42192-327-01 in 100-count bottle 30 mg (1/2 gr) NDC 42192-329-30 in 30-count bottle NDC 42192-329-90 in 90-count bottle NDC 42192-329-01 in 100-count bottle NDC 42192-329-10 in 1000-count bottle 60 mg (1 gr) NDC 42192-330-30 in 30-count bottle NDC 42192-330-90 in 90-count bottle NDC 42192-330-01 in 100-count bottle NDC 42192-330-10 in 1000-count bottle 90 mg (1 1/2 gr) NDC 42192-331-30 in 30-count bottle NDC 42192-331-90 in 90-count bottle NDC 42192-331-01 in 100-count bottle NDC 42192-331-10 in 1000-count bottle 120 mg (2 gr) NDC 42192-328-30 in 30-count bottle NDC 42192-328-90 in 90-count bottle NDC 42192-328-01 in 100-count bottle NP Thyroid ® tablets are available in the following strengths: 15 mg (1/4 grain) - tan, oval-shaped tablet, debossed on one side with “AP” and “327” on the other side.

30 mg (1/2 grain) – tan, round tablet, debossed on one side with “AP” and “329” on the other side. 60 mg (1 grain) – tan, round tablet, debossed on one side with “AP” and “330” on the other side. 90 mg (1 1/2 grain) – tan, round tablet, debossed on one side with “AP” and “331” on the other side.

120 mg (2 grain) – tan, round tablet, debossed on one side with “AP” and “328” on the other side.

📦 Storage and Handling 18 words

Store in a tight container protected from light and moisture. Store between 15° - 30°C (59° - 86°F).

📋 Description 72 words

NP Thyroid ® (thyroid tablets, USP) for oral use is a natural preparation derived from porcine thyroid glands. They contain both tetraiodothyronine sodium (T 4 levothyroxine) and triiodothyronine sodium (T 3 liothyronine) providing 38 mcg levothyroxine (T 4 ) and 9 mcg liothyronine (T 3 ) per grain of thyroid. The inactive ingredients are calcium stearate, dextrose (agglomerated) and mineral oil.

Contains no ingredient made from a gluten-containing grain (wheat, barley, rye).

💬 Information for Patients ~1 min read

Information for the Patient - Patients on thyroid hormone preparations and parents of children on thyroid therapy should be informed that: 1. Replacement therapy is to be taken essentially for life, with the exception of cases of transient hypothyroidism, usually associated with thyroiditis, and in those patients receiving a therapeutic trial of the drug. 2.

They should immediately report during the course of therapy any signs or symptoms of thyroid hormone toxicity, e.g., chest pain, increased pulse rate, palpitations, excessive sweating, heat intolerance, nervousness, or any other unusual event. 3. In case of concomitant diabetes mellitus, the daily dosage of antidiabetic medication may need readjustment as thyroid hormone replacement is achieved.

If thyroid medication is stopped, a downward readjustment of the dosage of insulin or oral hypoglycemic agent may be necessary to avoid hypoglycemia. At all times, close monitoring of urinary glucose levels is mandatory in such patients. 4.

In case of concomitant oral anticoagulant therapy, the prothrombin time should be measured frequently to determine if the dosage of oral anticoagulants is to be readjusted. 5. Instruct patients to discontinue biotin or any biotin-containing supplements for at least 2 days before thyroid function testing is conducted.

6. Partial loss of hair may be experienced by children in the first few months of thyroid therapy, but this is usually a transient phenomenon and later recovery is usually the rule.

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