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NDC 67684-1901 Lipiodol

Ethiodized Oil Injection Intra-arterial; Intralymphatic; Intrauterine - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 67684-1901?
  4. Lipiodol Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes

Product Information

NDC Product Code:
67684-1901
Proprietary Name:
Lipiodol
Non-Proprietary Name: [1]
Ethiodized Oil
Substance Name: [2]
Ethiodized Oil
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.
  • Intralymphatic - Administration within the lymph.
  • Intrauterine - Administration within the uterus.
    • Labeler Name: [5]
    Guerbet Llc
    Labeler Code:
    67684
    Product Label ID:
    511d1f64-5cb9-4baa-a123-96205467e59a
    FDA Application Number: [6]
    NDA009190
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    03-21-2014
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 67684-1901-1

    Package Description: 1 AMPULE in 1 CARTON / 10 mL in 1 AMPULE

    NDC Code 67684-1901-2

    Package Description: 1 VIAL in 1 CARTON / 10 mL in 1 VIAL

    Product Details

    What is NDC 67684-1901?

    The NDC code 67684-1901 is assigned by the FDA to the product Lipiodol which is a human prescription drug product labeled by Guerbet Llc. The generic name of Lipiodol is ethiodized oil. The product's dosage form is injection and is administered via intra-arterial; intralymphatic; intrauterine form. The product is distributed in 2 packages with assigned NDC codes 67684-1901-1 1 ampule in 1 carton / 10 ml in 1 ampule, 67684-1901-2 1 vial in 1 carton / 10 ml in 1 vial. 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 Lipiodol?

    Lipiodol is an oil-based radio-opaque contrast agent indicated for:hysterosalpingography in adultslymphography in adult and pediatric patientsselective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC)

    What are Lipiodol 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.
    • ETHIODIZED OIL 480 mg/mL - Ethyl ester of iodinated fatty acid of poppyseed oil. It contains 37% organically bound iodine and has been used as a diagnostic aid (radiopaque medium) and as an antineoplastic agent when part of the iodine is 131-I. (From Merck Index, 11th ed)

    Which are Lipiodol UNII Codes?

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

    Which are Lipiodol 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:

    * 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".