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Methimazole 5 mg Tablet, 100-count — NDC 64980-0264-01 package photo

Methimazole 5 mg Tablet, 100-count

by Rising Pharma Holdings, Inc. · 100 TABLET in 1 BOTTLE (64980-264-01)
NDC 64980-0264-01
🏷️ FDA NDC (as labeled) 64980-264-01 billing pads the product segment with a zero
Rx only Generic 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 →

🆔 Identity & classification

FDA NDC (as labeled) 64980-264-01
Product NDC 64980-264
11-digit billing NDC 64980026401
NCPDP billing unit EA — each (per item)
RxCUI 197941, 197942
UNII 554Z48XN5E
UPC 0364980265010
Application # ANDA202068
SPL Set ID 289ec852-176e-41aa-9f9a-b1f9b4196771
Established class (EPC) Thyroid Hormone Synthesis Inhibitor
Mechanism of action Thyroid Hormone Synthesis Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-04-22
Route ORAL
Dosage form TABLET
Substance METHIMAZOLE
GPI-14 28300010000305
GCN Seq No 006675
GCN 26401
HICL code 002855
Ingredient (HICL) Methimazole
HIC1 code P
Therapeutic class — broad (HIC1) Endocrine System
HIC2 code P3
Therapeutic class — intermediate (HIC2) Drugs Affecting Thyroid Function
HIC3 code P3L
Therapeutic class — specific (HIC3) Antithyroid Preparations
AHFS code 68:36.08.00
AHFS class Antithyroid Agents
FDB label name METHIMAZOLE 5 MG TABLET
FDB brand name Methimazole
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 64980-264-01 — 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 → 64980-0264-01. 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 Thyroid Hormone Synthesis Inhibitor class.

Pharmacologic class Thyroid Hormone Synthesis Inhibitor
Drug family (ATC) Sulfur-containing imidazole derivatives
How it works Thyroid Hormone Synthesis Inhibitors
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

LabelerRising Pharma Holdings, Inc.
Application holderRISING PHARMA HOLDINGS INC
FDA applicationANDA202068 (ANDA)
Labeler code64980
First marketedApr 2021
Product typeHuman Prescription Drug
Portfolio525 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 METHIMAZOLE 5 MG TABLET Ingredient Methimazole
📖 What it is MedlinePlus · NLM

Methimazole is used to treat hyperthyroidism, a condition that occurs when the thyroid gland produces too much thyroid hormone. It is also taken before thyroid surgery or radioactive iodine therapy. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Methimazole tells your thyroid gland to stop making so much thyroid hormone. When your thyroid is overactive — like in Graves' disease — it pumps out too much hormone and speeds ev...
  • What exactly is methimazole supposed to do for me?
  • Usually you'll take it in three separate doses spaced about 8 hours apart throughout the day — so think morning, afternoon, and evening. Your prescriber sets the exact dose based o...
  • How do I take it — do I take it all at once?
📖 Read our full Methimazole 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 White
ShapeRound
ImprintBP;656
Size8 mm
ScoringScored — splits in 2
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 EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

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 $0.071 $7.07 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.2005 $20.05 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $0.1781 $17.81 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2023 Dec 2025 Apr 2026 Aug 2026 $0.093 $0.071
▼ Down 22% over the last 12 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
Methimazole 5 mg 00832-6072-11 Upsher-Smith 100 tablets $0.071 AB Availability likely
Methimazole 5 mg 11788-0011-01 AiPing 100 tablets $0.071 AB Availability likely
Methimazole 5 mg 23155-0070-01 Heritage 100 tablets $0.071 AB Availability likely
Methimazole 5 mg 33342-0335-11 Macleods 100 tablets $0.071 AB Availability likely
Methimazole 5 mg 50268-0495-15 AvPAK 50 tablets $0.071 AB Availability likely
Methimazole 5 mg 60687-0669-01 American 100 tablets $0.071 AB Availability likely
Methimazole 5 mg 64380-0212-01 Strides 100 tablets $0.071 AB Availability likely
Methimazole 5 mgthis 64980-0264-01 Rising 100 tablets $0.071 AB Availability likely
Methimazole 5 mg 69452-0328-20 Bionpharma 100 tablets $0.071 AB Availability likely
methimazole 5 mg 72578-0212-01 Viona 100 tablets $0.071 AB Availability likely
Methimazole 5 mg 72603-0315-01 NORTHSTAR 100 tablets $0.071 AB Availability likely
Methimazole 5 mg 50090-6536-00 A-S 90 tablets AB FDA listed
Methimazole 5 mg 60429-0380-01 Golden 100 tablets AB FDA listed
Methimazole 5 mg 62135-0205-01 Chartwell 100 tablets AB FDA listed
Methimazole 5 mg 63629-8347-01 Bryant 30 tablets AB FDA listed
Methimazole 5 mg 63629-9249-01 Bryant 100 tablets AB FDA listed
Methimazole 5 mg 63629-9250-01 Bryant 500 tablets AB FDA listed
methimazole 5 mg 67046-1651-03 Coupler 30 tablets AB FDA listed
Methimazole 5 mg 68788-8226-03 Preferred 30 tablets AB FDA listed
Methimazole 5 mg 68788-8883-01 Preferred 100 tablets AB FDA listed
Methimazole 5 mg 70518-1506-00 REMEDYREPACK 30 tablets AB FDA listed
Methimazole 5 mg 71335-2881-01 Bryant 100 tablets AB FDA listed
Methimazole 5 mg 71335-3026-01 Bryant 500 tablets AB FDA listed
Methimazole 5 mg 72162-1802-01 Bryant 100 tablets AB FDA listed
Methimazole 5 mg 73190-0084-01 AvKARE 100 tablets AB FDA listed
methimazole 5 mg 76483-0082-00 SQUARE 100 tablets AB FDA listed
Methimazole 5 mg 70518-4747-00 REMEDYREPACK 100 tablets AB FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2021
On the market since
Apr 2021
📍
2026
Currently FDA-listed
5 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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 64980-0264-01, 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
26.4K
Units reimbursed last 4 qtrs
1.8M
Gross reimbursed last 4 qtrs
$359.3K
Avg / prescription
$13.62
Avg / unit
$0.2005
Latest quarter Q4 2025
7.4KRx
Medicaid pays / ea
$0.2005
gross reimbursed
vs
NADAC / ea
$0.0707
acquisition cost
=
Spread
+$0.1298
+184% 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
61% FFS 39% MCO
Fee-for-service · 15,991 Rx Managed care · 10,389 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 18,613 units · 238 per 100k residents WA Idaho: no data reported ID Montana: 1,201 units · 106 per 100k residents MT North Dakota: no data reported ND Minnesota: 1,382 units · 24.1 per 100k residents MN Wisconsin: 6,623 units · 112 per 100k residents WI Michigan: 9,699 units · 96.6 per 100k residents MI New York: 15,881 units · 81.1 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 5,559 units · 131 per 100k residents OR Nevada: 55,643 units · 1,742 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 480 units · 15.0 per 100k residents IA Illinois: 4,834 units · 38.5 per 100k residents IL Indiana: 2,907 units · 42.4 per 100k residents IN Ohio: 8,054 units · 68.3 per 100k residents OH Pennsylvania: 8,555 units · 66.0 per 100k residents PA New Jersey: 5,237 units · 56.4 per 100k residents NJ Massachusetts: no data reported MA California: 1,118,537 units · 2,871 per 100k residents CA Utah: 990 units · 29.0 per 100k residents UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 631 units · 10.2 per 100k residents MO Kentucky: no data reported KY West Virginia: 1,170 units · 66.1 per 100k residents WV Virginia: 8,544 units · 98.0 per 100k residents VA Maryland: 3,659 units · 59.2 per 100k residents MD Connecticut: 803 units · 22.2 per 100k residents CT Rhode Island: no data reported RI Arizona: 78,383 units · 1,055 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 3,234 units · 45.4 per 100k residents TN North Carolina: 13,081 units · 121 per 100k residents NC South Carolina: 2,184 units · 40.6 per 100k residents SC Delaware: no data reported DE Oklahoma: 5,121 units · 126 per 100k residents OK Louisiana: 31,825 units · 696 per 100k residents LA Mississippi: 3,404 units · 116 per 100k residents MS Alabama: 9,135 units · 179 per 100k residents AL Georgia: 4,908 units · 44.5 per 100k residents GA D.C.: no data reported DC Hawaii: 47,411 units · 3,304 per 100k residents HI Texas: 75,312 units · 247 per 100k residents TX Florida: 221,512 units · 980 per 100k residents FL
Units reimbursed · per 100k residents
10.23,304
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 Hawaii 3,304 /100k
2 California 2,871 /100k
3 Nevada 1,742 /100k
4 Arizona 1,055 /100k
5 Florida 980 /100k
6 Louisiana 696 /100k
7 Texas 247 /100k
8 Washington 238 /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.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Methimazole — the program that covers self-administered drugs. 10 manufacturers.
⚠️ 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 Methimazole. 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
$2.92M
Claims incl. refills
257.2K
Beneficiaries
179.3K
Spend / beneficiary
$16.29
Spend / claim
$11.35
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
64980-0264-01 You're viewing this 100 TABLET in 1 BOTTLE (64980-264-01) 2021-04-22 Active

📄 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.
🎯 Indications and Usage 46 words

INDICATIONS AND USAGE Methimazole tablets are indicated: • In patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option. • To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.

⏱️ Dosage and Administration 96 words

DOSAGE AND ADMINISTRATION Methimazole tablets are administered orally. The total daily dosage is usually given in 3 divided doses at approximately 8-hour intervals. Adult - The initial daily dosage is 15 mg for mild hyperthyroidism, 30 to 40 mg for moderately severe hyperthyroidism, and 60 mg for severe hyperthyroidism, divided into 3 doses at 8-hour intervals.

The maintenance dosage is 5 to 15 mg daily. Pediatric - Initially, the daily dosage is 0.4 mg/kg of body weight divided into 3 doses and given at 8-hour intervals. The maintenance dosage is approximately 1/2 of the initial dose.

Contraindications 20 words

CONTRAINDICATIONS Methimazole tablets are contraindicated in the presence of hypersensitivity to the drug or any of the other product components.

⚠️ Warnings ~2 min read

WARNINGS First Trimester Use of Methimazole and Congenital Malformations Methimazole crosses the placental membranes and can cause fetal harm, when administered in the first trimester of pregnancy. Rare instances of congenital defects, including aplasia cutis, craniofacial malformations (facial dysmorphism; choanal atresia), gastrointestinal malformations (esophageal atresia with or without tracheoesophageal fistula), omphalocele and abnormalities of the omphalomesenteric duct have occurred in infants born to mothers who received methimazole tablets in the first trimester of pregnancy.

If methimazole tablets are used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be warned of the potential hazard to the fetus. Because of the risk for congenital malformations associated with use of methimazole tablets in the first trimester of pregnancy, it may be appropriate to use other agents in pregnant women requiring treatment for hyperthyroidism. If methimazole tablets are used, the lowest possible dose to control the maternal disease should be given.

Agranulocytosis Agranulocytosis is potentially a life-threatening adverse reaction of methimazole therapy. Patients should be instructed to immediately report to their physicians any symptoms suggestive of agranulocytosis, such as fever or sore throat. Leukopenia, thrombocytopenia, and aplastic anemia (pancytopenia) may also occur.

The drug should be discontinued in the presence of agranulocytosis or aplastic anemia (pancytopenia), and the patient's bone marrow indices should be monitored. Liver Toxicity Although there have been reports of hepatotoxicity (including acute liver failure) associated with methimazole, the risk of hepatotoxicity appears to be less with methimazole than with propylthiouracil, especially in the pediatric population. Symptoms suggestive of hepatic dysfunction (anorexia, pruritis, right upper quadrant pain, etc.) should prompt evaluation of liver function (bilirubin, alkaline phosphatase) and hepatocellular integrity (ALT, AST).

Drug treatment should be discontinued promptly in the event of clinically significant evidence of liver abnormality including hepatic transaminase values exceeding 3 times the upper limit of normal. Hypothyroidism Methimazole can cause hypothyroidism necessitating routine monitoring of TSH and free T4 levels with adjustments in dosing to maintain a euthyroid state. Because the drug readily crosses placental membranes, methimazole can cause fetal goiter and cretinism when administered to a pregnant woman.

For this reason, it is important that a sufficient, but not excessive, dose be given during pregnancy (see PRECAUTIONS, Pregnancy ). Vasculitis Cases of vasculitis resulting in severe complications have been reported in patients receiving methimazole therapy. These cases of vasculitis include: leukocytoclastic cutaneous vasculitis, acute kidney injury and glomerulonephritis, alveolar/pulmonary hemorrhage, CNS vasculitis, and neuropathy.

Most cases were associated with anti-neutrophilic cytoplasmic antibodies (ANCA)-positive vasculitis. In some cases, vasculitis resolved/improved with drug discontinuation; however, more severe cases required treatment with additional measures including corticosteroids, immunosuppressant therapy, and plasmapheresis. If vasculitis is suspected, discontinue therapy and initiate appropriate intervention.

🤒 Adverse Reactions 142 words

ADVERSE REACTIONS Major adverse reactions (which occur with much less frequency than the minor adverse reactions) include inhibition of myelopoiesis (agranulocytosis, granulocytopenia, thrombocytopenia, and aplastic anemia), drug fever, a lupus-like syndrome, insulin autoimmune syndrome (which can result in hypoglycemic coma), hepatitis (jaundice may persist for several weeks after discontinuation of the drug), periarteritis, and hypoprothrombinemia. Nephritis occurs very rarely. There have been postmarketing case reports of acute pancreatitis.

There are reports of a vasculitis, often associated with the presence of anti-neutrophilic cytoplasmic antibodies (ANCA), resulting in severe complications (see WARNINGS ). Minor adverse reactions include skin rash, urticaria, nausea, vomiting, epigastric distress, arthralgia, paresthesia, loss of taste, abnormal loss of hair, myalgia, headache, pruritus, drowsiness, neuritis, edema, vertigo, skin pigmentation, jaundice, sialadenopathy, and lymphadenopathy. To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 118 words

Drug Interactions Anticoagulants (oral): Due to potential inhibition of vitamin K activity by methimazole, the activity of oral anticoagulants (e.g., warfarin) may be increased; additional monitoring of PT/INR should be considered, especially before surgical procedures. β-adrenergic blocking agents: Hyperthyroidism may cause an increased clearance of beta blockers with a high extraction ratio. A dose reduction of beta-adrenergic blockers may be needed when a hyperthyroid patient becomes euthyroid. Digitalis glycosides: Serum digitalis levels may be increased when hyperthyroid patients on a stable digitalis glycoside regimen become euthyroid; a reduced dosage of digitalis glycosides may be needed.

Theophylline: Theophylline clearance may decrease when hyperthyroid patients on a stable theophylline regimen become euthyroid; a reduced dose of theophylline may be needed.

🧒 Pediatric Use 36 words

Pediatric Use Because of postmarketing reports of severe liver injury in pediatric patient treated with propylthiouracil, methimazole is the preferred choice when an antithyroid drug is required for a pediatric patient (see DOSAGE AND ADMINISTRATION ).

🆘 Overdosage 129 words

OVERDOSAGE Signs and Symptoms Symptoms may include nausea, vomiting, epigastric distress, headache, fever, joint pain, pruritus, and edema. Aplastic anemia (pancytopenia) or agranulocytosis may be manifested in hours to days. Less frequent events are hepatitis, nephrotic syndrome, exfoliative dermatitis, neuropathies, and CNS stimulation or depression.

No information is available on the median lethal dose of the drug or the concentration of methimazole in biologic fluids associated with toxicity and/or death. Treatment To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center. In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in the patient.

In the event of an overdose, appropriate supportive treatment should be initiated as dictated by the patient’s medical status.

🧬 Clinical Pharmacology 71 words

CLINICAL PHARMACOLOGY Methimazole inhibits the synthesis of thyroid hormones and thus is effective in the treatment of hyperthyroidism. The drug does not inactivate existing thyroxine and tri-iodothyronine that are stored in the thyroid or circulating in the blood nor does it interfere with the effectiveness of thyroid hormones given by mouth or by injection. Methimazole is readily absorbed in the gastrointestinal tract, metabolized in the liver, and excreted in the urine.

📦 How Supplied / Storage and Handling 115 words

HOW SUPPLIED Methimazole tablets, USP are available in: Methimazole Tablets, USP 5 mg - White to off-white, round tablets debossed with "655" on one side and "B/P" on the other side. Bottles of 100 NDC 64980-264-01 Methimazole Tablets, USP 10 mg - White to off-white, round tablets debossed with "656" on one side and "B/P" on the other side. Bottles of 100 NDC 64980-265-01 STORAGE Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Dispense in tight, light-resistant container. Manufactured by: Appco Pharma LLC Piscataway, NJ 08854 Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Revised : 02/2025 200681 PIR26501-01

📋 Description 90 words

DESCRIPTION Methimazole, USP (1-methylimidazole-2-thiol) is a white, crystalline substance that is freely soluble in water. It differs chemically from the drugs of the thiouracil series primarily because it has a 5- instead of a 6-membered ring. Methimazole tablet, USP contains 5 or 10 mg (43.8 or 87.6 μmol) methimazole, an orally administered antithyroid drug.

Each tablet also contains lactose monohydrate, magnesium stearate, and pregelatinized maize starch. The molecular weight is 114.16, and the molecular formula is C 4 H 6 N 2 S. The structural formula is as follows: methimazole-struc.jpg

💬 Information for Patients 75 words

Information for Patients Patients should be advised that if they become pregnant or intend to become pregnant while taking an antithyroid drug, they should contact their physician immediately about their therapy. Inform patients that cases of vasculitis resulting in severe complications have occurred with methimazole tablets. Inform patients to promptly report symptoms that may be associated with vasculitis including new rash, hematuria or decreased urine output, dyspnea or hemoptysis (see WARNINGS and ADVERSE REACTIONS ).

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.