Product Details

LEVOTHYROXINE SODIUM tablet 112mcg (0.112mg) 100 Tablets

Manufacturer: Lupin Pharmaceuticals, Inc.

MFG#: 68180-0970-01

NDC: 68180-0970-01

PID: 309364

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Description

Indications and Usage:

Hypothyroidism

Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.

Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression

Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.

Limitations of Use:

  • Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.1)].
  • Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.

Product Properties:

Description N
DESI Drug Ind -; -
Drug Category USES: Levothyroxine is used to treat an underactive thyroid (hypothyroidism). It replaces or provides more thyroid hormone, which is normally produced by the thyroid gland. Low thyroid hormone levels can occur naturally or when the thyroid gland is injured by radiation/medications or removed by surgery. Having enough thyroid hormone is important for maintaining normal mental and physical activity. In children, having enough thyroid hormone is important for normal mental and physical development. This medication is also used to treat other types of thyroid disorders (such as thyroid cancer). This medication should not be used to treat infertility unless it is caused by low thyroid hormone levels.
Drug Type Code COMMON BRAND NAME(S): Levothroid, Levoxyl, Synthroid, Unithroid
HCPCS 1
Medical Coverage -
Termination Date (lee-voe-thye-ROX-een)
Active Ingredients 2132 levothyroxine sodium 55038
AHFS Class 68360400 THYROID AGENTS
DEA Class NC
Dose Form TABLET
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 6652 levothyroxine sodium ORAL TABLET 112 MCG
Inactive Ingredients 10141 red dye; 11039 sodium bicarbonate 144558; 2272 mannitol 69658
OMP Family -
Product Category RX Pharmaceuticals
Strength 112MCG
Common Brand Name -
Drug Interaction -
Allocation Period -
Case Quantity 96
Drug Form Pack Size 100
Form TABLET
Hazard Code -
Listed Chemical -
NIOSH Code -
Orange Book AB Products meeting necessary bioequivalence requirements.
Retail Pack Quantity 1
Returnable Status Returnable
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Unit EA
Unit Size 100
How to Use -
Missed Dose 100
Notes TAB
Overdose A1
Phonetic Pronunciation -
Precautions -
Side Effects -
Storage 01/18/2019
Uses -

Frequently Asked Questions (FAQs)

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LEVOTHYROXINE SODIUM tablet 112mcg (0.112mg) 100 Tablets is manufactured by Lupin Pharmaceuticals, Inc..

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