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  4. NDC Product Code: 0019-0953 Conray

NDC 0019-0953 Conray

Iothalamate Meglumine Injection Intravascular - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 0019-0953?
  4. Conray Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Pharmacologic Classes

Product Information

NDC Product Code:
0019-0953
Proprietary Name:
Conray
Non-Proprietary Name: [1]
Iothalamate Meglumine
Substance Name: [2]
Iothalamate Meglumine
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s): [4]
  • Intravascular - Administration within a vessel or vessels.
    • Labeler Name: [5]
    Liebel-flarsheim Company Llc
    Labeler Code:
    0019
    Product Label ID:
    1292abfc-496f-4df7-9a08-72072953e1f1
    FDA Application Number: [6]
    NDA013295
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    10-14-2003
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 0019-0953-05

    Package Description: 25 VIAL, GLASS in 1 BOX / 50 mL in 1 VIAL, GLASS

    NDC Code 0019-0953-10

    Package Description: 12 BOTTLE, GLASS in 1 BOX / 100 mL in 1 BOTTLE, GLASS

    NDC Code 0019-0953-23

    Package Description: 25 VIAL, GLASS in 1 BOX / 30 mL in 1 VIAL, GLASS

    NDC Code 0019-0953-50

    Package Description: 12 BOTTLE, GLASS in 1 BOX / 150 mL in 1 BOTTLE, GLASS

    Product Details

    What is NDC 0019-0953?

    The NDC code 0019-0953 is assigned by the FDA to the product Conray which is a human prescription drug product labeled by Liebel-flarsheim Company Llc. The generic name of Conray is iothalamate meglumine. The product's dosage form is injection and is administered via intravascular form. The product is distributed in 4 packages with assigned NDC codes 0019-0953-05 25 vial, glass in 1 box / 50 ml in 1 vial, glass, 0019-0953-10 12 bottle, glass in 1 box / 100 ml in 1 bottle, glass, 0019-0953-23 25 vial, glass in 1 box / 30 ml in 1 vial, glass, 0019-0953-50 12 bottle, glass in 1 box / 150 ml in 1 bottle, glass. 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 Conray?

    Conray is indicated for use in excretory urography, cerebral angiography, peripheral arteriography, venography, arthrography, direct cholangiography, endoscopic retrograde cholangiopancreatography, contrast enhancement of computed tomographic brain images, cranial computerized angiotomography, intravenous digital subtraction angiography and arterial digital subtraction angiography. Conray may also be used for enhancement of computed tomographic scans performed for detection and evaluation of lesions in the liver, pancreas, kidneys, abdominal aorta, mediastinum, abdominal cavity and retroperitoneal space. Continuous or multiple scans separated by intervals of 1 to 3 seconds during the first 30 to 90 seconds post-injection of the contrast medium (dynamic CT scanning) may provide enhancement of diagnostic significance, and may be of benefit in establishing diagnoses of certain lesions in these sites with greater assurance than is possible with CT alone, and in supplying additional features of the lesions. In other cases, the contrast agent may allow visualization of lesions not seen with CT alone, or may help to define suspicious lesions seen with unenhanced CT (see CLINICAL PHARMACOLOGY). Subsets of patients in whom delayed body CT scans might be helpful have not been identified. Inconsistent results have been reported and abnormal and normal tissues may be isodense during the time frame used for delayed CT scanning. The risks of such indiscriminate use of contrast media are well known and such use is not recommended. At present, consistent results have been documented using dynamic CT techniques only.

    What are Conray 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.
    • IOTHALAMATE MEGLUMINE 600 mg/mL - A radiopaque medium used for urography, angiography, venography, and myelography. It is highly viscous and binds to plasma proteins.

    Which are Conray UNII Codes?

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

    Which are Conray 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:

    • EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)
    • SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)

    Which are the Pharmacologic Classes for Conray?

    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.

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    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".