Methimazole tablets, USP 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
Methimazole tablets, USP are administered orally. The total daily dosage is usually given in 3 divided doses at approximately 8-hour intervals. The initial daily dosage is 15 mg for mild hyperthyroidism, 30 mg 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 mg to 15 mg daily. Initially, the daily dosage is 0....
www.fda.gov/medwatchMethimazole tablets, 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.
Each tablet contains 5 mg or 10 mg (43.8 mcmol or 87.6 mcmol) methimazole USP, an orally administered antithyroid drug.
Each tablet also contains anhydrous lactose, colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch (corn) and talc.
The molecular weight is 114.16, and the molecular formula is C 4H 6N 2S. The structural formula is as follows:
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.
Methimazole tablets, USP are indicated:
Methimazole is contraindicated in the presence of hypersensitivity to the drug or any of the other product components.
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 in the first trimester of pregnancy. If methimazole is 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 in the first trimester of pregnancy it may be appropriate to use other agents in pregnant women requiring treatment for hyperthyroidism. If methimazole is used, the lowest possible dose to control the maternal disease should be given.
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, aplastic anemia (pancytopenia), ANCA-positive vasculitis, hepatitis, or exfoliative dermatitis, and the patient’s bone marrow indices should be monitored.
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.
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).
Patients who receive methimazole should be under close surveillance and should be cautioned to report immediately any evidence of illness, particularly sore throat, skin eruptions, fever, headache, or general malaise. In such cases, white-blood-cell and differential counts should be obtained to determine whether agranulocytosis has developed. Particular care should be exercised with patients who are receiving additional drugs known to cause agranulocytosis.
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.
Because methimazole may cause hypoprothrombinemia and bleeding, prothrombin time should be monitored during therapy with the drug, especially before surgical procedures.
Thyroid function tests should be monitored periodically during therapy. Once clinical evidence of hyperthyroidism has resolved, the finding of a rising serum TSH indicates that a lower maintenance dose of methimazole should be employed.
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.
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.
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 clearance may decrease when hyperthyroid patients on a stable theophylline regimen become euthyroid; a reduced dose of theophylline may be needed.
In a 2 year study, rats were given methimazole at doses of 0.5 mg/kg/day, 3 mg/kg/day and 18 mg/kg/day. These doses were 0.3, 2, and 12 times the 15 mg/day maximum human maintenance dose (when calculated on the basis of surface area). Thyroid hyperplasia, adenoma, and carcinoma developed in rats at the two higher doses. The clinical significance of these findings is unclear.
See WARNINGS.
If methimazole is used during the first trimester of pregnancy or if the patient becomes pregnant while taking this drug, the patient should be warned of the potential hazard to the fetus.
In pregnant women with untreated or inadequately treated Graves’ disease, there is an increased risk of adverse events of maternal heart failure, spontaneous abortion, preterm birth, stillbirth and fetal or neonatal hyperthyroidism.
Because methimazole crosses placental membranes and can induce goiter and cretinism in the developing fetus, hyperthyroidism should be closely monitored in pregnant women and treatment adjusted such that a sufficient, but not excessive, dose be given during pregnancy. In many pregnant women, the thyroid dysfunction diminishes as the pregnancy proceeds; consequently, a reduction of dosage may be possible. In some instances, anti-thyroid therapy can be discontinued several weeks or months before delivery.
Due to the rare occurrence of congenital malformations associated with methimazole use, it may be appropriate to use an alternative anti-thyroid medication in pregnant women requiring treatment for hyperthyroidism particularly in the first trimester of pregnancy during organogenesis.
Given the potential maternal adverse effects of propylthiouracil (e.g., hepatotoxicity), it may be preferable to switch from propylthiouracil to methimazole for the second and third trimesters.
Methimazole is present in breast milk. However, several studies found no effect on clinical status in nursing infants of mothers taking methimazole. A long-term study of 139 thyrotoxic lactating mothers and their infants failed to demonstrate toxicity in infants who are nursed by mothers receiving treatment with methimazole. Monitor thyroid function at frequent (weekly or biweekly) intervals.
Because of postmarketing reports of severe liver injury in pediatric patients treated with propylthiouracil, methimazole is the preferred choice when an antithyroid drug is required for a pediatric patient (see DOSAGE AND ADMINISTRATION).
Major adverse reactions (which occur with much less frequency than the minor adverse reactions) include inhibition of myelopoieses (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.
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.
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.
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.
Methimazole tablets, USP are administered orally. The total daily dosage is usually given in 3 divided doses at approximately 8-hour intervals.
The initial daily dosage is 15 mg for mild hyperthyroidism, 30 mg 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 mg to 15 mg daily.
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.
Methimazole Tablets, USP, for oral administration, are available as
5 mg
White, round, biconvex, beveled tablets, scored on one side and debossed “E” over “205” on the other side and supplied as:
Unit dose packages of 100 (10 x 10) NDC 68084-275-01
10 mg
White, round, biconvex, beveled tablets, scored on one side and debossed “E” over “210” on the other side and supplied as:
Unit dose packages of 100 (10 x 10) NDC 68084-276-01
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
FOR YOUR PROTECTION: Do not use if blister is torn or broken.
KEEP THIS ANDALL MEDICATION OUT OF THE REACH OF CHILDREN.
WARNING – This drug may cause toxic reaction. If such reactions occur, discontinue the drug. Constant supervision of patient is essential.
To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
American Health Packaging unit dose blisters (see
How Supplied section) contain drug product from Sandoz Inc. as follows:
(5 mg / 100 UD) NDC 68084-275-01 packaged from NDC 0185-0205
(10 mg / 100 UD) NDC 68084-276-01 packaged from NDC 0185-0210
Distributed by:
American Health Packaging
Columbus, OH 43217
8227601/1215OS
NDC 68084-275-01
Methimazole
Tablets, USP
5 mg
100 Tablets (10 x 10)
Each Tablet Contains:
Methimazole USP..............................................................5 mg
WARNING: This drug may cause toxic reaction. If such reactions
occur, discontinue the drug. Constant supervision of patient is
essential.
Usual Dosage: See package insert for full prescribing information.
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].
Keep this and all drugs out of reach of children.
FOR YOUR PROTECTION: Do not use if blister is torn or broken.
Rx Only
The drug product contained in this package is from
NDC # 0185-0205, Sandoz Inc.
Distributed by:
American Health Packaging
Columbus, Ohio 43217
027501
0227501/1215OS
Methimazole
Tablet, USP
5 mg
NDC 68084-276-01
Methimazole
Tablets, USP
10 mg
100 Tablets (10 x 10)
Each Tablet Contains:
Methimazole USP..............................................................10 mg
WARNING: This drug may cause toxic reaction. If such reactions
occur, discontinue the drug. Constant supervision of patient is
essential.
Usual Dosage: See package insert for full prescribing information.
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].
Keep this and all drugs out of reach of children.
FOR YOUR PROTECTION: Do not use if blister is torn or broken.
Rx Only
The drug product contained in this package is from
NDC # 0185-0210, Sandoz Inc.
Distributed by:
American Health Packaging
Columbus, Ohio 43217
027601
0227601/0116OS
Methimazole
Tablet, USP
10 mg
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68084-275-01 | EA - Each | 68084-275 | f006e226-1d86-4713-be12-f9bb849b5ea5 | 1 | 2012-07-24 |
| 68084-275-11 | EA - Each | 68084-275 | 52c880b5-38cd-42ea-b414-a5c66b26f213 | 1 | 2012-07-24 |
| 68084-276-01 | EA - Each | 68084-276 | 86242a4b-31f1-4505-a652-5af59929dcae | 1 | 2012-07-24 |
| 68084-276-11 | EA - Each | 68084-276 | 898c4509-e4b9-430b-b94c-1d16ac1ffb73 | 1 | 2012-07-24 |
| 0185-0205-01 | EA - Each | 0185-0205 | 97b5edea-688b-48ee-a498-3080d86bab3b | 1 | 2012-07-24 |
| 0185-0205-10 | EA - Each | 0185-0205 | 479f7fbc-ffa8-4bf4-a9d6-f096eac4723c | 1 | 2012-07-24 |
| 0185-0210-01 | EA - Each | 0185-0210 | 4d75731c-a9cb-498a-ba2e-38ebfafaa2f2 | 1 | 2012-07-24 |
| 0185-0210-10 | EA - Each | 0185-0210 | df8f11aa-b794-481a-aad4-873f2d264570 | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| METHIMAZOLE | ACTIVE INGREDIENT | 554Z48XN5E | 4 | |
| METHIMAZOLE | ACTIVE MOIETY | 554Z48XN5E | 4 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 4 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 4 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 4 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 4 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68084-275 | 68084-275-11, 68084-275-01 |
| 68084-276 | 68084-276-11, 68084-276-01 |
| 0185-0205 | |
| 0185-0210 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ANHYDROUS LACTOSE | 3SY5LH9PMK | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| TALC | 7SEV7J4R1U | IACT |
| METHIMAZOLE | 554Z48XN5E | ACTIB |
| ANHYDROUS LACTOSE | 3SY5LH9PMK | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| TALC | 7SEV7J4R1U | IACT |
| METHIMAZOLE | 554Z48XN5E | ACTIB |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | GRANULE / ORAL | 629 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY | 47.5 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / BUCCAL | 17.5 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | GRANULE, FOR SUSPENSION / ORAL | 14 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION, EXTENDED RELEASE / ORAL | 113 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUPPOSITORY / RECTAL | 14 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION / ORAL | 400 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, CHEWABLE / ORAL | 1412 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | DROPS / ORAL | NA | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / SUBLINGUAL | 409 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, FOR SUSPENSION / ORAL | 24 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, DELAYED RELEASE / ORAL | 40 mg | ||
| ANHYDROUS LACTOSE | ANHYDROUS LACTOSE | 3SY5LH9PMK | CAPSULE, EXTENDED RELEASE / ORAL | 869 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | RING / VAGINAL | 2 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION / ORAL | 900 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / SUBLINGUAL | 17.5 mg | ||
| ANHYDROUS LACTOSE | ANHYDROUS LACTOSE | 3SY5LH9PMK | GRANULE, FOR SUSPENSION / ORAL | 3025 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 69 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, SOLUBLE / ORAL | 2 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | CREAM / VAGINAL | 586 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | CAPSULE, DELAYED RELEASE / ORAL | 2087 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 9 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | POWDER, FOR SUSPENSION / ORAL | NA | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | PASTILLE / ORAL | NA | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 150 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 357 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| TALC | TALC | 7SEV7J4R1U | LOZENGE / ORAL | 50 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | DROPS / ORAL | NA | ||
| ANHYDROUS LACTOSE | ANHYDROUS LACTOSE | 3SY5LH9PMK | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 375 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, ORALLY DISINTEGRATING / ORAL | 80 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SUSPENSION / ORAL | 64 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 20 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 520 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / SUBLINGUAL | 10 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION/ DROPS / ORAL | 90 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, DELAYED RELEASE / ORAL | 420 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, DELAYED RELEASE / ORAL | 349 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED / ORAL | 3 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, EXTENDED RELEASE / ORAL | 5119 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, ORALLY DISINTEGRATING / ORAL | 366 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE PARTICLES / ORAL | 170 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / TOPICAL | 6 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 750 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | INSERT / VAGINAL | 69 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | CAPSULE, COATED PELLETS / ORAL | 265 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, SUGAR COATED / ORAL | NA | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET / SUBLINGUAL | 505 mg | ||
| TALC | TALC | 7SEV7J4R1U | OINTMENT / TOPICAL | 74.6 %w/w | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | GRANULE / ORAL | 8946 mg | ||
| ANHYDROUS LACTOSE | ANHYDROUS LACTOSE | 3SY5LH9PMK | TABLET, FOR SUSPENSION / ORAL | 15 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / TOPICAL | 104 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING / ORAL | 100 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 53 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, EXTENDED RELEASE / ORAL | 300 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | LOZENGE / TRANSMUCOSAL | 100 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION / SUBCUTANEOUS | 98 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SUSPENSION / ORAL | 2553 mg | ||
| TALC | TALC | 7SEV7J4R1U | ELIXIR / ORAL | 4.5 mg/5ml |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040411-001 | METHIMAZOLE | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2001-03-27 | |
| A040411-002 | METHIMAZOLE | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2001-03-27 |
| Application-product | TE code |
|---|---|
| A040411-001 | AB |
| A040411-002 | AB |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A040411-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2001-03-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A040411-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2001-03-27 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A040411-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2001-03-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A040411-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2001-03-27 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040411-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2001-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040411-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2001-03-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040411-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2001-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040411-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2001-03-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040411-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2001-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040411-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2001-03-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040411-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2001-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040411-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2001-03-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040411-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2001-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040411-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2001-03-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040411-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2001-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040411-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2001-03-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040411-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2001-03-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040411-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2001-03-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040411-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2001-03-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040411-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2001-03-27 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040411-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2001-03-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040411-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2001-03-27 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040411-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2001-03-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040411-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2001-03-27 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040411-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2001-03-27 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040411-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2001-03-27 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040411-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2001-03-27 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040411-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2001-03-27 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040411-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2001-03-27 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040411-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2001-03-27 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A040411-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2001-03-27 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A040411-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2001-03-27 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040411-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2001-03-27 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040411-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2001-03-27 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A040411-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2001-03-27 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A040411-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2001-03-27 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A040411-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2001-03-27 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A040411-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2001-03-27 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A040411-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2001-03-27 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A040411-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2001-03-27 | 74a2ff9319b5… |
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A040411-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A040411-002 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A040411-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A040411-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A040411-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040411-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040411-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040411-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040411-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040411-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040411-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040411-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040411-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040411-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040411-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040411-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040411-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040411-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040411-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040411-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040411-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040411-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040411-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040411-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040411-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040411-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040411-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040411-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040411-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040411-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040411-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A040411-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040411-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040411-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A040411-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A040411-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A040411-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A040411-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A040411-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A040411-002 | AB | 1 | 74a2ff9319b5… |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 7df2cbb0-3f2d-6ca0-e053-2991aa0a4cfd | f7675cf7-77df-461a-aee4-a6206970431b | 2018-12-26 | Warnings, Adverse reactions | 7df2cbb0-3f2d-6ca0-e053-2991aa0a4cfd f7675cf7-77df-461a-aee4-a6206970431b |
Adverse event summaries are temporarily unavailable. Other product information remains available.