NDC 0019-1332 Optiray 300

Ioversol Injection Intra-arterial; Intravenous - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0019-1332
Proprietary Name:
Optiray 300
Non-Proprietary Name: [1]
Ioversol
Substance Name: [2]
Ioversol
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]
  • Intra-arterial - Administration within an artery or arteries.
  • Intravenous - Administration within or into a vein or veins.
  • Intra-arterial - Administration within an artery or arteries.
  • Intravenous - Administration within or into a vein or veins.
  • Intra-arterial - Administration within an artery or arteries.
  • Intravenous - Administration within or into a vein or veins.
  • Labeler Name: [5]
    Liebel-flarsheim Company Llc
    Labeler Code:
    0019
    FDA Application Number: [6]
    NDA019710
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    03-04-2012
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Packages

    NDC Code 0019-1332-00

    Package Description: 20 SYRINGE, PLASTIC in 1 CARTON / 100 mL in 1 SYRINGE, PLASTIC

    NDC Code 0019-1332-06

    Package Description: 25 BOTTLE, GLASS in 1 CARTON / 50 mL in 1 BOTTLE, GLASS

    NDC Code 0019-1332-11

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

    NDC Code 0019-1332-16

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

    NDC Code 0019-1332-21

    Package Description: 12 BOTTLE, GLASS in 1 CARTON / 200 mL in 1 BOTTLE, GLASS

    NDC Code 0019-1332-61

    Package Description: 6 BOTTLE, GLASS in 1 CARTON / 500 mL in 1 BOTTLE, GLASS

    NDC Code 0019-1332-65

    Package Description: 6 BOTTLE, GLASS in 1 CARTON / 500 mL in 1 BOTTLE, GLASS

    NDC Code 0019-1332-75

    Package Description: 20 SYRINGE, PLASTIC in 1 CARTON / 50 mL in 1 SYRINGE, PLASTIC

    NDC Code 0019-1332-78

    Package Description: 20 SYRINGE, PLASTIC in 1 CARTON / 50 mL in 1 SYRINGE, PLASTIC

    NDC Code 0019-1332-83

    Package Description: 20 SYRINGE, PLASTIC in 1 CARTON / 100 mL in 1 SYRINGE, PLASTIC

    NDC Code 0019-1332-90

    Package Description: 20 SYRINGE, PLASTIC in 1 CARTON / 100 mL in 1 SYRINGE, PLASTIC

    NDC Code 0019-1332-91

    Package Description: 20 SYRINGE, PLASTIC in 1 CARTON / 75 mL in 1 SYRINGE, PLASTIC

    Product Details

    What is NDC 0019-1332?

    The NDC code 0019-1332 is assigned by the FDA to the product Optiray 300 which is a human prescription drug product labeled by Liebel-flarsheim Company Llc. The generic name of Optiray 300 is ioversol. The product's dosage form is injection and is administered via intra-arterial; intravenous form. The product is distributed in 12 packages with assigned NDC codes 0019-1332-00 20 syringe, plastic in 1 carton / 100 ml in 1 syringe, plastic, 0019-1332-06 25 bottle, glass in 1 carton / 50 ml in 1 bottle, glass, 0019-1332-11 12 bottle, glass in 1 carton / 100 ml in 1 bottle, glass, 0019-1332-16 12 bottle, glass in 1 carton / 150 ml in 1 bottle, glass, 0019-1332-21 12 bottle, glass in 1 carton / 200 ml in 1 bottle, glass, 0019-1332-61 6 bottle, glass in 1 carton / 500 ml in 1 bottle, glass, 0019-1332-65 6 bottle, glass in 1 carton / 500 ml in 1 bottle, glass, 0019-1332-75 20 syringe, plastic in 1 carton / 50 ml in 1 syringe, plastic, 0019-1332-78 20 syringe, plastic in 1 carton / 50 ml in 1 syringe, plastic, 0019-1332-83 20 syringe, plastic in 1 carton / 100 ml in 1 syringe, plastic, 0019-1332-90 20 syringe, plastic in 1 carton / 100 ml in 1 syringe, plastic, 0019-1332-91 20 syringe, plastic in 1 carton / 75 ml in 1 syringe, plastic. 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 Optiray 300?

    Optiray is indicated for:

    What are Optiray 300 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.

    Which are Optiray 300 UNII Codes?

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

    Which are Optiray 300 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:

    Which are the Pharmacologic Classes for Optiray 300?

    * 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".