NDC 50090-5586 Liothyronine Sodium

Tablet Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
50090-5586
Proprietary Name:
Liothyronine Sodium
Non-Proprietary Name: [1]
Liothyronine Sodium
Substance Name: [2]
Liothyronine Sodium
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    A-s Medication Solutions
    Labeler Code:
    50090
    FDA Application Number: [6]
    ANDA214803
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    02-01-2021
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325 - WHITE TO OFF WHITE)
    Shape:
    ROUND (C48348)
    Size(s):
    6 MM
    Imprint(s):
    582
    Score:
    1

    Product Packages

    NDC Code 50090-5586-0

    Package Description: 100 TABLET in 1 BOTTLE

    NDC Code 50090-5586-1

    Package Description: 90 TABLET in 1 BOTTLE

    Product Details

    What is NDC 50090-5586?

    The NDC code 50090-5586 is assigned by the FDA to the product Liothyronine Sodium which is a human prescription drug product labeled by A-s Medication Solutions. The product's dosage form is tablet and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 50090-5586-0 100 tablet in 1 bottle , 50090-5586-1 90 tablet in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Liothyronine Sodium?

    Liothyronine is used to treat an underactive thyroid (hypothyroidism). It replaces or provides more thyroid hormone, which is normally made by the thyroid gland. Liothyronine is a man-made form of thyroid hormone. 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 helps you stay healthy. For children, having enough thyroid hormone helps them grow and learn normally. This medication is also used to treat other types of thyroid problems (such as certain types of goiters, thyroid cancer). It can also be used to test for certain types of thyroid disease. This medication should not be used to treat infertility unless it is caused by low thyroid hormone levels.

    What are Liothyronine Sodium Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • LIOTHYRONINE SODIUM 5 ug/1 - A T3 thyroid hormone normally synthesized and secreted by the thyroid gland in much smaller quantities than thyroxine (T4). Most T3 is derived from peripheral monodeiodination of T4 at the 5' position of the outer ring of the iodothyronine nucleus. The hormone finally delivered and used by the tissues is mainly T3.

    Which are Liothyronine Sodium UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Liothyronine Sodium Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Liothyronine Sodium?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

    Which are the Pharmacologic Classes for Liothyronine Sodium?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Liothyronine


    Liothyronine is used to treat hypothyroidism (a condition where the thyroid gland does not produce enough thyroid hormone). Liothyronine is also used to treat a goiter (an enlarged thyroid gland) and to test for hyperthyroidism (a condition where the thyroid gland produces too much thyroid hormone). Liothyronine is in a class of medications called thyroid agents. It works by supplying the thyroid hormones normally produced by the body. Currently, there is not enough evidence from clinical studies to support the use of liothyronine, alone or in combination with other medications, as the first choice of therapy to treat hypothyroidism.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".