METHIMAZOLE tablet

1. Principal Display Panel
2. Package Label Principal Display Panel -
3. Package Label Principal Display Panel - 10 Mg(100 Tablets)
4. Description
5. Clinical Pharmacology
6. Indications And Usage
7. Contraindications
8. Warnings
9. Precautions
10. Adverse Reactions
11. Overdosage
12. Dosage And Administration
13. How Supplied
14. Methimazole Tablets, Usp, 5 Mg X 100 Tablets - Label
15. Methimazole Tablets, Usp, 10 Mg X 100 Tablets - Label
16. Description
17. Clinical Pharmacology
18. Indications And Usage
19. Contraindications
20. Warnings
21. Precautions
22. Adverse Reactions
23. Overdosage
24. Dosage And Administration
25. How Supplied
26. Packaging Information
27. Package/label Display Panel Carton 5 Mg
28. Package/label Display Panel Blister 5 Mg
29. Package/label Display Panel Carton 10 Mg
30. Package/label Display Panel Blister 10 Mg
31. Principal Display Panel - Container Label - 5 Mg
32. Principal Display Panel - Container Label - 10 Mg
33. Package Label Principal Display Panel - 10 Mg (1000 Tablets)
34. Package Label.principal Display Panel
35. Storage
36. Methimazole
37. References
38. Methimazole Tablet
39. Methimazole 10mg Tablet

Principal Display Panel ⮝

METHIMAZOLE methimazole tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-0681(NDC:64376-656) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHIMAZOLE (UNII: 554Z48XN5E) (METHIMAZOLE - UNII:554Z48XN5E) METHIMAZOLE 10 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) STARCH, CORN (UNII: O8232NY3SJ) MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics Color WHITE (to off-white) Score 2 pieces Shape ROUND (biconvex) Size 9mm Flavor Imprint Code BP;656 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68788-0681-2 20 in 1 BOTTLE; Type 0: Not a Combination Product 02/27/2014 2 NDC:68788-0681-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/27/2014 3 NDC:68788-0681-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 02/27/2014 4 NDC:68788-0681-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 02/27/2014 5 NDC:68788-0681-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/27/2014

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202068 02/27/2014

Labeler - Preferred Pharmaceuticals, Inc. (791119022)

Registrant - Preferred Pharmaceuticals, Inc. (791119022)

Establishment
Name	Address	ID/FEI	Business Operations
Preferred Pharmaceuticals, Inc.		791119022	REPACK(68788-0681)

Revised: 12/2016 Document Id: 2f5d3988-e004-4c55-9659-4ba724a43d5d 34391-3 Set id: 665bf04b-9732-4e24-944b-6599ba2730de Version: 3 Effective Time: 20161216 Preferred Pharmaceuticals, Inc.

Package Label Principal Display Panel - ⮝

METHIMAZOLE methimazole tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-3027(NDC:23155-071) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHIMAZOLE (UNII: 554Z48XN5E) (METHIMAZOLE - UNII:554Z48XN5E) METHIMAZOLE 10 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U)

Product Characteristics Color white (WHITE TO OFF WHITE) Score 2 pieces Shape ROUND Size 8mm Flavor Imprint Code HP;71 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68071-3027-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 07/30/2018

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040734 01/15/2012

Labeler - NuCare Pharmaceuticals,Inc. (010632300)

Establishment
Name	Address	ID/FEI	Business Operations
NuCare Pharmaceuticals,Inc.		010632300	relabel(68071-3027)

Revised: 7/2018 Document Id: 723f830c-a500-55d1-e053-2a91aa0a403c 34391-3 Set id: 723f830c-a4ff-55d1-e053-2a91aa0a403c Version: 1 Effective Time: 20180730 NuCare Pharmaceuticals,Inc.

Package Label Principal Display Panel - 10 Mg(100 Tablets) ⮝

METHIMAZOLE methimazole tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:23155-070 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHIMAZOLE (UNII: 554Z48XN5E) (METHIMAZOLE - UNII:554Z48XN5E) METHIMAZOLE 5 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U)

Product Characteristics Color WHITE (WHITE TO OFF WHITE) Score 2 pieces Shape ROUND Size 6mm Flavor Imprint Code HP;70 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:23155-070-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 01/15/2012 2 NDC:23155-070-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/15/2012

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040734 01/15/2012

METHIMAZOLE methimazole tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:23155-071 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHIMAZOLE (UNII: 554Z48XN5E) (METHIMAZOLE - UNII:554Z48XN5E) METHIMAZOLE 10 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U)

Product Characteristics Color WHITE (WHITE TO OFF WHITE) Score 2 pieces Shape ROUND Size 8mm Flavor Imprint Code HP;71 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:23155-071-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/15/2012 2 NDC:23155-071-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 01/15/2012

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040734 01/15/2012

Labeler - Heritage Pharmaceuticals Inc. (780779901)

Establishment
Name	Address	ID/FEI	Business Operations
Heritage Pharma Labs, Inc		189630168	ANALYSIS(23155-070, 23155-071) , LABEL(23155-070, 23155-071) , MANUFACTURE(23155-070, 23155-071) , PACK(23155-070, 23155-071)

Revised: 11/2018 Document Id: 707c2490-50a2-4ca6-ae3c-ac7d9310d2a9 34391-3 Set id: 8c3a9aaa-cdde-404b-9af6-5a88ef649aac Version: 8 Effective Time: 20181106 Heritage Pharmaceuticals Inc.

Description ⮝

Methimazole (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 or 10 mg (43.8 or 87.6 mol) methimazole, an orally administered antithyroid drug.

Each tablet also contains lactose monohydrate, magnesium stearate, pregelatinized starch and talc.

The molecular weight is 114.17, and the molecular formula is C 4H 6N 2S. The structural formula is as follows:

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.

Indications And Usage ⮝

Methimazole is 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.

Contraindications ⮝

Methimazole is contraindicated in the presence of hypersensitivity to the drug or any of the other product components.

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 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

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.

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).

Precautions ⮝

General

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.

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.

Laboratory Tests

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.

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.

-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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a 2 year study, rats were given methimazole at doses of 0.5, 3, 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.

Pregnancy

Pregnancy Category D

(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.

Nursing Mothers

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.

Pediatric Use

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).

Adverse Reactions ⮝

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.

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.

Dosage And Administration ⮝

Methimazole is 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.

How Supplied ⮝

Methimazole Tablets USP, 5 mg - round, white to off white bi-convex tablet. Debossed HP bisect 70 on one side and plain on the reverse side.

They are available in:

Bottles of 100 NDC 60429-380-01

Methimazole Tablets USP, 10 mg - round, white to off white bi-convex tablet. Debossed HP bisect 71 on one side and plain on the reverse side.

They are available in:

1. Bottles of 100 NDC 60429-381-01

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 for:

Heritage Pharmaceuticals Inc.

Eatontown, NJ 07724

1.866.901.DRUG (3784)

Marketed/Packaged by:

GSMS, Incorporated

Camarillo, CA 93012

51U000000174US02

Revised: 12/2015

Methimazole Tablets, Usp, 5 Mg X 100 Tablets - Label ⮝

NDC 0185-0205-01

Methimazole Tablets, USP

5 mg

Rx only

100 Tablets

Sandoz

Methimazole Tablets, Usp, 10 Mg X 100 Tablets - Label ⮝

NDC 0185-0210-01

Methimazole Tablets, USP

10 mg

Rx only

100 Tablets

Sandoz

METHIMAZOLE methimazole tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0185-0205 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHIMAZOLE (UNII: 554Z48XN5E) (METHIMAZOLE - UNII:554Z48XN5E) METHIMAZOLE 5 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics Color WHITE Score 2 pieces Shape ROUND Size 6mm Flavor Imprint Code E;205 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0185-0205-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2001 09/27/2022 2 NDC:0185-0205-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2001 06/27/2022

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040411 03/27/2001 10/27/2022

METHIMAZOLE methimazole tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0185-0210 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHIMAZOLE (UNII: 554Z48XN5E) (METHIMAZOLE - UNII:554Z48XN5E) METHIMAZOLE 10 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics Color WHITE Score 2 pieces Shape ROUND Size 9mm Flavor Imprint Code E;210 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0185-0210-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2001 10/27/2022 2 NDC:0185-0210-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2001 06/27/2022

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040411 03/27/2001 10/27/2022

Labeler - Eon Labs, Inc. (012656273)

Revised: 2/2019 Document Id: 3b0906f3-98c9-496d-9c4f-7783d938c53d 34391-3 Set id: a57ff449-e3b7-48b6-9acf-c719a9770e8a Version: 21 Effective Time: 20190207 Eon Labs, Inc.

Description  ⮝

Methimazole (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 or 10 mg (43.8 or 87.6 mol) methimazole, an orally administered antithyroid drug. Each tablet also contains lactose monohydrate, magnesium stearate and pregelatinized starch.

The molecular weight is 114.17, and the molecular formula is C4H6N2S. The structural formula is as follows:

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 triiodothyronine 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.

The actions and use of methimazole are similar to those of propylthiouracil. On a weight basis, the drug is at least 10 times as potent as propylthiouracil, but methimazole may be less consistent in action.

Methimazole is readily absorbed from the gastrointestinal tract. It is metabolized rapidly and requires frequent administration.

Methimazole is excreted in the urine.

In laboratory animals, various regimens that continuously suppress thyroid function and thereby increase TSH secretion result in thyroid tissue hypertrophy. Under such conditions, the appearance of thyroid and pituitary neoplasms has also been reported.

Regimens that have been studied in this regard include antithyroid agents as well as dietary iodine deficiency, subtotal thyroidectomy, implantation of autonomous thyrotropic hormone-secreting pituitary tumors, and administration of chemical goitrogens.

Indications And Usage  ⮝

Methimazole is indicated in the medical treatment of hyperthyroidism. Long-term therapy may lead to remission of the disease.

Methimazole may be used to ameliorate hyperthyroidism in preparation for subtotal thyroidectomy or radioactive iodine therapy.

Methimazole is also used when thyroidectomy is contraindicated or not advisable.

Contraindications  ⮝

Methimazole is contraindicated in the presence of hypersensitivity to the drug and in nursing mothers because the drug is excreted in milk.

Warnings  ⮝

Agranulocytosis is potentially a serious side effect. Patients should be instructed to report to their physicians any symptoms 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), hepatitis, or exfoliative dermatitis. The patient s bone marrow function should be monitored.

Due to the similar hepatic toxicity profiles of methimazole and propylthiouracil, attention is drawn to the severe hepatic reactions which have occurred with both drugs. There have been rare reports of fulminant hepatitis, hepatic necrosis, encephalopathy, and death.

Symptoms suggestive of hepatic dysfunction (anorexia, pruritus, right upper quadrant pain, etc.) should prompt evaluation of liver function. 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 fetal harm when administered to a pregnant woman. Methimazole readily crosses the placental membranes and can induce goiter and even cretinism in the developing fetus. In addition, rare instances of congenital defects: aplasia cutis, as manifested by scalp defects; esophageal atresia with tracheoesophageal fistula; and choanal atresia with absent/ hypoplastic nipples, have occurred in infants born to mothers who received methimazole during 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.

Since the above congenital defects have been reported in offspring of patients treated with methimazole, it may be appropriate to use other agents in pregnant women requiring treatment for hyperthyroidism.

Postpartum patients receiving methimazole should not nurse their babies.

Precautions  ⮝

General

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 made to determine whether agranulocytosis has developed. Particular care should be exercised with patients who are receiving additional drugs known to cause agranulocytosis.

Laboratory Tests

Because methimazole may cause hypoprothrombinemia and bleeding, prothrombin time should be monitored during therapy with the drug, especially before surgical procedures (see General under PRECAUTIONS).

Periodic monitoring of thyroid function is warranted, and the finding of an elevated TSH warrants a decrease in the dosage of methimazole.

Drug Interactions

Anticoagulants (oral) - The activity of oral anticoagulants may be potentiated by anti-vitamin-K activity attributed to methimazole.

-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 required.

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

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a 2 year study, rats were given methimazole at doses of 0.5, 3, 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.

Pregnancy

Category D (See WARNINGS)

Methimazole used judiciously is an effective drug in hyperthyroidism complicated by pregnancy. In many pregnant women, the thyroid dysfunction diminishes as the pregnancy proceeds; consequently, a reduction in dosage may be possible. In some instances, use of methimazole can be discontinued 2 or 3 weeks before delivery.

Nursing Mothers

The drug appears in human breast milk and its use is contraindicated in nursing mothers (see WARNINGS).

Pediatric use

(See DOSAGE AND ADMINISTRATION).

Adverse Reactions  ⮝

Major adverse reactions (which occur with much less frequency than the minor adverse reactions) include inhibition of myelopoiesis (agranulocytosis, granulocytopenia, and thrombocytopenia), 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.

It should be noted that about 10% of patients with untreated hyperthyroidism have leukopenia (white blood cell count of less than 4,000/mm3), often with relative granulopenia.

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. Although not well studied, methimazole-induced agranulocytosis is generally associated with doses of 40 mg or more in patients older than 40 years of age.

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.

Telephone numbers of certified poison control centers are listed in the Physicians Desk Reference (PDR) . In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient.

Protect the patient s airway and support ventilation and perfusion. Meticulously monitor and maintain, within acceptable limits, the patient s vital signs, blood gases, serum electrolytes, etc. The patient s bone marrow function should be monitored. Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which, in many cases, is more effective than emesis or lavage; consider charcoal instead of or in addition to gastric emptying. Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. Safeguard the patient s airway when employing gastric emptying or charcoal.

Forced diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion have not been established as beneficial for an overdose of methimazole.

Dosage And Administration  ⮝

Methimazole is administered orally. It is usually given in 3 equal doses at approximately 8-hour intervals.

Adults

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.

How Supplied  ⮝

Methimazole Tablets, USP 10 mg - white to off-white, round, biconvex tablets, with B to the left and P to right of the break line on one side and 656 on the other.

They are available in:

Bottle of 20 - 68788-0681-2

Bottle of 30 - 68788-0681-3

Bottle of 60 - 68788-0681-6

Bottle of 90 - 68788-0681-9

Bottle of 100 - 68788-0681-1

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.

Dispense in a tight, light-resistant container. Keep tightly closed.

Store at controlled room temperature 15 30 C (59 86 F).

Manufactured for:
Boca Pharmacal, LLC
a Subsidiary of Qualitest Pharmaceuticals
Huntsville, AL 35811
1-800-444-4011

Iss. 12/14

QT-TED-655

Repackaged By: Preferred Pharmaceuticals Inc.

Packaging Information ⮝

American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Par Pharmaceutical as follows:
(5 mg / 100 UD) NDC 60687-357-01 packaged from NDC 49884-640
(10 mg / 100 UD) NDC 60687-370-01 packaged from NDC 49884-641

Distributed by:
American Health Packaging
Columbus, OH 43217

8435701/0218F

Package/label Display Panel Carton 5 Mg ⮝

NDC 60687- 357-01

Methimazole
Tablets, USP

5 mg

100 Tablets (10 x 10) Rx Only

Each Tablet Contains:
Methimazole ................................................................................ 5 mg

Usual Dosage: See package insert for full prescribing information.

WARNING: This drug may cause toxic reactions. If such reactions
occur, discontinue the drug. Constant supervision of patient is
essential.

Store at controlled room temperature 15 to 30 C (59 to 86 F).

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from
NDC # 49884-640, Par Pharmaceutical.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

735701
0435701/0619OS

Package/label Display Panel Blister 5 Mg ⮝

Methimazole
Tablet, USP

5 mg

Package/label Display Panel Carton 10 Mg ⮝

NDC 60687- 370-01

Methimazole
Tablets, USP

10 mg

100 Tablets (10 x 10) Rx Only

Each Tablet Contains:
Methimazole ..............................................................................10 mg

Usual Dosage: See package insert for full prescribing information.

WARNING: This drug may cause toxic reactions. If such reactions
occur, discontinue the drug. Constant supervision of patient is
essential.

Store at controlled room temperature 15 to 30 C (59 to 86 F).

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from
NDC # 49884-641, Par Pharmaceutical.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

737001
0437001/0619OS

Package/label Display Panel Blister 10 Mg ⮝

Methimazole
Tablet, USP

10 mg

METHIMAZOLE methimazole tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-357(NDC:49884-640) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHIMAZOLE (UNII: 554Z48XN5E) (METHIMAZOLE - UNII:554Z48XN5E) METHIMAZOLE 5 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U)

Product Characteristics Color white (off-white) Score 2 pieces Shape ROUND Size 6mm Flavor Imprint Code EM;5 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60687-357-01 100 in 1 BOX, UNIT-DOSE 08/28/2018 1 NDC:60687-357-11 1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040350 08/28/2018

METHIMAZOLE methimazole tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-370(NDC:49884-641) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHIMAZOLE (UNII: 554Z48XN5E) (METHIMAZOLE - UNII:554Z48XN5E) METHIMAZOLE 10 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U)

Product Characteristics Color white (off-white) Score 2 pieces Shape ROUND Size 8mm Flavor Imprint Code EM;10 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60687-370-01 100 in 1 BOX, UNIT-DOSE 09/13/2018 1 NDC:60687-370-11 1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040350 09/13/2018

Labeler - American Health Packaging (929561009)

Establishment
Name	Address	ID/FEI	Business Operations
American Health Packaging		929561009	repack(60687-357, 60687-370)

Revised: 6/2019 Document Id: 8c3d57a2-6dbc-1a41-e053-2a95a90a0bf6 34391-3 Set id: 8e11a745-7e48-47a5-9d71-3f0b90d80550 Version: 3 Effective Time: 20190626 American Health Packaging

Principal Display Panel - Container Label - 5 Mg ⮝

NDC 51293-820-01

ECI Pharmaceuticals

Methimazole
Tablets, USP

5 mg

Rx Only
100 Tablets

Principal Display Panel - Container Label - 10 Mg ⮝

NDC 51293-821-01

ECI Pharmaceuticals

Methimazole
Tablets, USP

10 mg

Rx Only
100 Tablets

METHIMAZOLE methimazole tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51293-820 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHIMAZOLE (UNII: 554Z48XN5E) (METHIMAZOLE - UNII:554Z48XN5E) METHIMAZOLE 5 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, POTATO (UNII: 8I089SAH3T) TALC (UNII: 7SEV7J4R1U)

Product Characteristics Color WHITE Score 2 pieces Shape ROUND Size 7mm Flavor Imprint Code VM Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51293-820-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2016

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040547 07/01/2016

METHIMAZOLE methimazole tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51293-821 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHIMAZOLE (UNII: 554Z48XN5E) (METHIMAZOLE - UNII:554Z48XN5E) METHIMAZOLE 10 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, POTATO (UNII: 8I089SAH3T) TALC (UNII: 7SEV7J4R1U)

Product Characteristics Color WHITE Score 2 pieces Shape ROUND Size 7mm Flavor Imprint Code XM Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51293-821-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2016

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040547 07/01/2016

Labeler - ECI Pharmaceuticals, LLC (962476029)

Registrant - ECI Pharmaceuticals, LLC (962476029)

Revised: 12/2018 Document Id: 6d695680-15d6-4822-9b47-a910814918b8 34391-3 Set id: 68942ec1-763a-4757-96ad-0e749aba348c Version: 3 Effective Time: 20181225 ECI Pharmaceuticals, LLC

Package Label Principal Display Panel - 10 Mg (1000 Tablets) ⮝

METHIMAZOLE methimazole tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-380(NDC:23155-070) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHIMAZOLE (UNII: 554Z48XN5E) (METHIMAZOLE - UNII:554Z48XN5E) METHIMAZOLE 5 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U)

Product Characteristics Color white (white to off-white) Score 2 pieces Shape ROUND Size 6mm Flavor Imprint Code HP;70 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60429-380-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/31/2013

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040734 05/31/2013

METHIMAZOLE methimazole tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-381(NDC:23155-071) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHIMAZOLE (UNII: 554Z48XN5E) (METHIMAZOLE - UNII:554Z48XN5E) METHIMAZOLE 10 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U)

Product Characteristics Color white (white to off-white) Score 2 pieces Shape ROUND Size 8mm Flavor Imprint Code HP;71 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60429-381-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/31/2013

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040734 05/31/2013

Labeler - Golden State Medical Supply Inc. (603184490)

Establishment
Name	Address	ID/FEI	Business Operations
Golden State Medical Supply Inc.		603184490	repack(60429-380, 60429-381) , relabel(60429-380, 60429-381)

Revised: 11/2018 Document Id: 7a1c8048-fb04-846d-e053-2991aa0a2527 34391-3 Set id: 4eff3321-2fce-4bab-94af-7b16e333beed Version: 4 Effective Time: 20181107 Golden State Medical Supply Inc.

Package Label.principal Display Panel  ⮝

NDC 66336-0623-XX

NDC 66336-0623-30

METHIMAZOLE methimazole tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66336-623(NDC:23155-071) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHIMAZOLE (UNII: 554Z48XN5E) (METHIMAZOLE - UNII:554Z48XN5E) METHIMAZOLE 10 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U)

Product Characteristics Color WHITE (white to off-white) Score 2 pieces Shape ROUND Size 8mm Flavor Imprint Code HP;71 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66336-623-30 30 in 1 BOTTLE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040734 01/16/2012

Labeler - Dispensing Solutions, Inc. (066070785)

Registrant - PSS World Medical, Inc. (101822682)

Establishment
Name	Address	ID/FEI	Business Operations
Dispensing Solutions, Inc.		066070785	relabel(66336-623) , repack(66336-623)

Revised: 7/2013 Document Id: 5c5af70c-6daf-4514-823e-b089adc31785 34391-3 Set id: 06833532-64c2-439a-a4ee-ed30989b61e4 Version: 1 Effective Time: 20130716 Dispensing Solutions, Inc.

Storage ⮝

Store at controlled room temperature 15 to 30 C (59 to 86 F). Dispense in tight, light-resistant container. Manufactured for: Rising Pharmaceuticals, Inc Allendale, NJ 07401 Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977

Methimazole ⮝

METHIMAZOLE methimazole tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-2366(NDC:49884-640) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHIMAZOLE (UNII: 554Z48XN5E) (METHIMAZOLE - UNII:554Z48XN5E) METHIMAZOLE 5 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U)

Product Characteristics Color WHITE (off-white) Score 2 pieces Shape ROUND Size 6mm Flavor Imprint Code EM;5 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-2366-0 90 in 1 BOTTLE; Type 0: Not a Combination Product 04/22/2016

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040350 03/29/2000

Labeler - A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Business Operations
A-S Medication Solutions		830016429	RELABEL(50090-2366) , REPACK(50090-2366)

Revised: 1/2018 Document Id: 7cb58310-5c05-452d-afcd-c0ad87e0749a 34391-3 Set id: 54e30401-7ad3-464b-9aa5-8e4a6527893b Version: 3 Effective Time: 20180123 A-S Medication Solutions

References ⮝

Sandoz Inc.

Princeton, NJ 08540

Rev. 03/06

OS7631

MF0205REV03/06

MG #16035

Methimazole Tablet ⮝

METHIMAZOLE methimazole tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-6408(NDC:49884-641) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHIMAZOLE (UNII: 554Z48XN5E) (METHIMAZOLE - UNII:554Z48XN5E) METHIMAZOLE 10 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U)

Product Characteristics Color WHITE (off-white) Score 2 pieces Shape ROUND Size 8mm Flavor Imprint Code EM;10 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63629-6408-1 45 in 1 BOTTLE; Type 0: Not a Combination Product 09/17/2015 2 NDC:63629-6408-2 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/26/2016

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040350 04/13/2000

Labeler - Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Business Operations
Bryant Ranch Prepack		171714327	REPACK(63629-6408) , RELABEL(63629-6408)

Revised: 2/2017 Document Id: 5fd213cc-2e9d-4571-bc19-9c3a9b710322 34391-3 Set id: 7a1cc4ef-5488-49fa-a7a7-9402c7b413c8 Version: 2 Effective Time: 20170216 Bryant Ranch Prepack

Methimazole 10mg Tablet ⮝

METHIMAZOLE methimazole tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71335-0883(NDC:23155-071) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHIMAZOLE (UNII: 554Z48XN5E) (METHIMAZOLE - UNII:554Z48XN5E) METHIMAZOLE 10 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U)

Product Characteristics Color WHITE (WHITE TO OFF WHITE) Score 2 pieces Shape ROUND Size 8mm Flavor Imprint Code HP;71 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71335-0883-1 30 in 1 BOTTLE; Type 0: Not a Combination Product 06/29/2018 2 NDC:71335-0883-2 15 in 1 BOTTLE; Type 0: Not a Combination Product 06/29/2018

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040734 01/15/2012

Labeler - Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Business Operations
Bryant Ranch Prepack		171714327	REPACK(71335-0883) , RELABEL(71335-0883)

Revised: 12/2018 Document Id: 9b302079-6dd5-419c-b8e9-1c689095bbcc 34391-3 Set id: 381052c4-891c-4ae4-b63e-65229126cbca Version: 3 Effective Time: 20181205 Bryant Ranch Prepack