NDC 54702-501 Oraltag

Iohexol For Solution Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
54702-501
Proprietary Name:
Oraltag
Non-Proprietary Name: [1]
Iohexol
Substance Name: [2]
Iohexol
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
For Solution - A product, usually a solid, intended for solution prior to administration.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Interpharma Praha, A.s.
    Labeler Code:
    54702
    FDA Application Number: [6]
    NDA205383
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    07-01-2016
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Packages

    NDC Code 54702-501-52

    Package Description: 12 POUCH in 1 CASE / 1 BOTTLE, PLASTIC in 1 POUCH (54702-501-51) / 1 FOR SOLUTION in 1 BOTTLE, PLASTIC (54702-501-21)

    NDC Code 54702-501-62

    Package Description: 25 POUCH in 1 CASE / 1 BOTTLE, PLASTIC in 1 POUCH (54702-501-51) / 1 FOR SOLUTION in 1 BOTTLE, PLASTIC (54702-501-21)

    NDC Code 54702-501-98

    Package Description: 12 POUCH in 1 CASE / 1 BOTTLE, PLASTIC in 1 POUCH (54702-501-99) / 1 FOR SOLUTION in 1 BOTTLE, PLASTIC (54702-501-21)

    Product Details

    What is NDC 54702-501?

    The NDC code 54702-501 is assigned by the FDA to the product Oraltag which is a human prescription drug product labeled by Interpharma Praha, A.s.. The generic name of Oraltag is iohexol. The product's dosage form is for solution and is administered via oral form. The product is distributed in 3 packages with assigned NDC codes 54702-501-52 12 pouch in 1 case / 1 bottle, plastic in 1 pouch (54702-501-51) / 1 for solution in 1 bottle, plastic (54702-501-21), 54702-501-62 25 pouch in 1 case / 1 bottle, plastic in 1 pouch (54702-501-51) / 1 for solution in 1 bottle, plastic (54702-501-21), 54702-501-98 12 pouch in 1 case / 1 bottle, plastic in 1 pouch (54702-501-99) / 1 for solution in 1 bottle, plastic (54702-501-21). 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 Oraltag?

    This medication is used before X-ray imaging tests (such as CT scans). Iohexol contains iodine and belongs to a class of drugs known as contrast media or dyes. It works by adding contrast to body parts and fluids in these imaging tests. Iohexol improves the images obtained during a CT scan, so your doctor can more easily diagnose your condition.

    What are Oraltag 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.
    • IOHEXOL 4.5 g/1 - An effective non-ionic, water-soluble contrast agent which is used in myelography, arthrography, nephroangiography, arteriography, and other radiographic procedures. Its low systemic toxicity is the combined result of low chemotoxicity and low osmolality.

    Which are Oraltag UNII Codes?

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

    Which are the Pharmacologic Classes for Oraltag?

    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.

    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".