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NDC 50633-910 Thyrosafe

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

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 50633-910?
  5. Thyrosafe Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Patient Education

Product Information

NDC Product Code:
50633-910
Proprietary Name:
Thyrosafe
Non-Proprietary Name: [1]
Potassium Iodide
Substance Name: [2]
Potassium Iodide
NDC Directory Status:
Human Otc 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]
    Btg International Inc.
    Labeler Code:
    50633
    Product Label ID:
    47762f8f-30e2-445d-aaa1-e04479f8dd5b
    FDA Application Number: [6]
    ANDA076350
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    09-30-2002
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325 - WHITE)
    Shape:
    ROUND (C48348)
    Size(s):
    9 MM
    Score:
    4

    Product Packages

    NDC Code 50633-910-20

    Package Description: 160 BOX in 1 CARTON / 20 BLISTER PACK in 1 BOX / 1 TABLET in 1 BLISTER PACK

    Product Details

    What is NDC 50633-910?

    The NDC code 50633-910 is assigned by the FDA to the product Thyrosafe which is a human over the counter drug product labeled by Btg International Inc.. The generic name of Thyrosafe is potassium iodide. The product's dosage form is tablet and is administered via oral form. The product is distributed in a single package with assigned NDC code 50633-910-20 160 box in 1 carton / 20 blister pack in 1 box / 1 tablet in 1 blister pack. 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 Thyrosafe?

    Potassium iodide is used to loosen and break up mucus in the airways. This helps you cough up the mucus so you can breathe more easily if you have long-term lung problems (e.g., asthma, chronic bronchitis, emphysema). This medication is known as an expectorant. Potassium iodide is also used along with antithyroid medicines to prepare the thyroid gland for surgical removal, to treat certain overactive thyroid conditions (hyperthyroidism), and to protect the thyroid in a radiation exposure emergency. It works by shrinking the size of the thyroid gland and decreasing the amount of thyroid hormones produced. In a radiation emergency, potassium iodide blocks only the thyroid from absorbing radioactive iodine, protecting it from damage and reducing the risk of thyroid cancer. Use this medication along with other emergency measures that will be recommended to you by public health and safety officials (e.g., finding safe shelter, evacuation, controlling food supply).

    What are Thyrosafe 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.
    • POTASSIUM IODIDE 65 mg/1 - An inorganic compound that is used as a source of iodine in thyrotoxic crisis and in the preparation of thyrotoxic patients for thyroidectomy. (From Dorland, 27th ed)

    Which are Thyrosafe UNII Codes?

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

    Which are Thyrosafe 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 Thyrosafe?

    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:

    * Please review the disclaimer below.

    Patient Education

    Potassium Iodide


    Potassium iodide is used to protect the thyroid gland from taking in radioactive iodine that may be released during a nuclear radiation emergency. Radioactive iodine can damage the thyroid gland. You should only take potassium iodide if there is a nuclear radiation emergency and public officials tell you that you should take it. Potassium iodide is in a class of medications called anti-thyroid medications. It works by blocking radioactive iodine from entering the thyroid gland. Potassium iodide can protect you from the effects of radioactive iodine that may be released during a nuclear radiation emergency, but will not protect you from other dangerous substances that may be released during the emergency. Public officials may tell you to do other things to protect yourself during the emergency. Follow all of these directions carefully.
    [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".