Iosat Tablet
NDC 51803-002

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 51803-002?
  5. Iosat Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Patient Education

Product Information

Iosat (potassium iodide) is a NDA-approved product labeled by Anbex Inc.. Potassium iodide is used to loosen and break up mucus in the airways. It is supplied as a white tablet for oral administration. This product entry covers the primary NDC 51803-002 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
51803-002
Proprietary Name:
Iosat
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
Code Navigator:

Clinical Specifications

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 & Regulatory Data

Labeler Name: [5]
Anbex Inc.
Labeler Code:
51803
Product Label ID:
bab815ee-47ef-4c87-a60d-e0d7863ad871
FDA Application Number: [6]
NDA018664
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
05-01-2013
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
ROUND (C48348)
Size(s):
5 MM
Imprint(s):
IOSAT
Score:
4

Code Structure Chart

Product Details

What is NDC 51803-002?

The NDC code 51803-002 is assigned by the FDA to the product Iosat. It is commonly known by its generic name, potassium iodide. This pharmaceutical product is labeled by Anbex Inc. and is currently categorized as listed product. The medication is a tablet administered via oral route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 51803-002-01, 51803-002-02. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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 Active Ingredients of this product?

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 the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 this product?

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:

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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.
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* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
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.
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".