NDC 69945-035 Ultra-technekow V4

Technetium Tc-99m Injection, Solution Intravenous - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
69945-035
Proprietary Name:
Ultra-technekow V4
Non-Proprietary Name: [1]
Technetium Tc-99m
Substance Name: [2]
Technetium Tc-99m Sodium Pertechnetate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route(s): [4]
  • Intravenous - Administration within or into a vein or veins.
  • Labeler Name: [5]
    Curium Us Llc
    Labeler Code:
    69945
    FDA Application Number: [6]
    NDA017243
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    06-10-2014
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 69945-035-08

    Package Description: 1 INJECTION, SOLUTION in 1 CARTON

    Product Details

    What is NDC 69945-035?

    The NDC code 69945-035 is assigned by the FDA to the product Ultra-technekow V4 which is a human prescription drug product labeled by Curium Us Llc. The generic name of Ultra-technekow V4 is technetium tc-99m. The product's dosage form is injection, solution and is administered via intravenous form. The product is distributed in a single package with assigned NDC code 69945-035-08 1 injection, solution in 1 carton . 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 Ultra-technekow V4?

    The Ultra-Technekow™ V4 generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits.Sodium Pertechnetate Tc 99m is used IN ADULTS as an agent for:     Thyroid Imaging     Salivary Gland Imaging     Urinary Bladder Imaging (direct isotopic cystography) for detection of vesico-ureteral reflux     Nasolacrimal Drainage System Imaging (dacryoscintigraphy)Sodium Pertechnetate Tc 99m is used IN PEDIATRIC PATIENTS as an agent for:     Thyroid Imaging     Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux

    What are Ultra-technekow V4 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 Ultra-technekow V4 UNII Codes?

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

    • TECHNETIUM TC-99M SODIUM PERTECHNETATE (UNII: A0730CX801)
    • TECHNETIUM TC-99M PERTECHNETATE (UNII: PPP8783IQ1) (Active Moiety)

    * 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".