MedPath

Thyroid

Thyroid Tablets USPRx only

Approved
Approval ID

9b517204-3d73-410f-aa86-741f29e51906

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 15, 2023

Manufacturers
FDA

ANI Pharmaceuticals, Inc.

DUNS: 145588013

Products 5

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Thyroid

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code62559-743
Product Classification
G
Generic Name
Thyroid
Product Specifications
Route of AdministrationORAL
Effective DateJune 15, 2023
FDA Product Classification

INGREDIENTS (6)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSE 112Inactive
Code: X7XJ6RM9Q2
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
ANHYDROUS DEXTROSEInactive
Code: 5SL0G7R0OK
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
THYROIDActive
Quantity: 90 mg in 1 1
Code: 6RV024OAUQ
Classification: ACTIB

Thyroid

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code62559-741
Product Classification
G
Generic Name
Thyroid
Product Specifications
Route of AdministrationORAL
Effective DateJune 15, 2023
FDA Product Classification

INGREDIENTS (6)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSE 112Inactive
Code: X7XJ6RM9Q2
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
ANHYDROUS DEXTROSEInactive
Code: 5SL0G7R0OK
Classification: IACT
THYROIDActive
Quantity: 30 mg in 1 1
Code: 6RV024OAUQ
Classification: ACTIB

Thyroid

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code62559-744
Product Classification
G
Generic Name
Thyroid
Product Specifications
Route of AdministrationORAL
Effective DateJune 15, 2023
FDA Product Classification

INGREDIENTS (6)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSE 112Inactive
Code: X7XJ6RM9Q2
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
ANHYDROUS DEXTROSEInactive
Code: 5SL0G7R0OK
Classification: IACT
THYROIDActive
Quantity: 120 mg in 1 1
Code: 6RV024OAUQ
Classification: ACTIB

Thyroid

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code62559-740
Product Classification
G
Generic Name
Thyroid
Product Specifications
Route of AdministrationORAL
Effective DateJune 15, 2023
FDA Product Classification

INGREDIENTS (6)

MICROCRYSTALLINE CELLULOSE 112Inactive
Code: X7XJ6RM9Q2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
ANHYDROUS DEXTROSEInactive
Code: 5SL0G7R0OK
Classification: IACT
THYROIDActive
Quantity: 15 mg in 1 1
Code: 6RV024OAUQ
Classification: ACTIB

Thyroid

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code62559-742
Product Classification
G
Generic Name
Thyroid
Product Specifications
Route of AdministrationORAL
Effective DateJune 15, 2023
FDA Product Classification

INGREDIENTS (6)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSE 112Inactive
Code: X7XJ6RM9Q2
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
ANHYDROUS DEXTROSEInactive
Code: 5SL0G7R0OK
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
THYROIDActive
Quantity: 60 mg in 1 1
Code: 6RV024OAUQ
Classification: ACTIB

Drug Labeling Information

OVERDOSAGE SECTION

LOINC: 34088-5Updated: 6/15/2023

OVERDOSAGE

Signs and Symptoms

Excessive doses of thyroid result in a hypermetabolic state resembling in every respect the condition of endogenous origin. The condition may be self- induced.

Treatment of Overdosage

Dosage should be reduced or therapy temporarily discontinued if signs and symptoms of overdosage appear.

Treatment may be reinstituted at a lower dosage. In normal individuals, normal hypothalamic-pituitary-thyroid axis function is restored in 6 to 8 weeks after thyroid suppression.

Treatment of acute massive thyroid hormone overdosage is aimed at reducing gastrointestinal absorption of the drugs and counteracting central and peripheral effects, mainly those of increased sympathetic activity. Vomiting may be induced initially if further gastrointestinal absorption can reasonably be prevented and barring contraindications such as coma, convulsions, or loss of the gagging reflex. Treatment is symptomatic and supportive. Oxygen may be administered and ventilation maintained. Cardiac glycosides may be indicated if congestive heart failure develops. Measures to control fever, hypoglycemia, or fluid loss should be instituted if needed. Antiadrenergic agents, particularly propranolol, have been used advantageously in the treatment of increased sympathetic activity. Propranolol may be administered intravenously at a dosage of 1 to 3 mg, over a 10-minute period or orally, 80 to 160 mg/day, initially, especially when no contraindications exist for its use.

Other adjunctive measures may include administration of cholestyramine to interfere with thyroxine absorption, and glucocorticoids to inhibit conversion of T4 to T3.

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