1. Home
  2. Labeler Index
  3. Cyclomedica Australia Pty Limited
  4. NDC Product Code: 73814-987 Technegas

NDC 73814-987 Technegas

Kit For The Preparation Of Technetium Tc 99m-labeled Carbon Inhalation Aerosol Kit - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 73814-987?
  5. Technegas Uses
  6. Active Ingredients UNII Codes

Product Information

NDC Product Code:
73814-987
Proprietary Name:
Technegas
Non-Proprietary Name: [1]
Kit For The Preparation Of Technetium Tc 99m-labeled Carbon Inhalation Aerosol
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Labeler Name: [5]
Cyclomedica Australia Pty Limited
Labeler Code:
73814
Product Label ID:
10320da4-0c64-4d03-e063-6394a90a1923
FDA Application Number: [6]
NDA022335
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
09-29-2023
Listing Expiration Date: [11]
12-31-2025
Exclude Flag: [12]
N
Code Navigator:

Product Characteristics

Color(s):
BLACK (C48323 - TECHNEGAS CRUCIBLE, BLACK TO DARK GREY)

Code Structure Chart

Product Details

What is NDC 73814-987?

The NDC code 73814-987 is assigned by the FDA to the product Technegas which is a human prescription drug product labeled by Cyclomedica Australia Pty Limited. The generic name of Technegas is kit for the preparation of technetium tc 99m-labeled carbon inhalation aerosol. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 73814-987-20 1 kit in 1 carton * 1 in 1 carton (gs1:19340598000050) * 50 aerosol in 1 carton (73814-986-20). 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 Technegas?

TECHNEGAS, when used with sodium pertechnetate Tc 99m in the Technegas Plus System, provides technetium Tc 99m-labeled carbon inhalation aerosol (Technegas Aerosol), for use in adults and pediatric patients aged 6 years and older for:• visualization of pulmonary ventilation • evaluation of pulmonary embolism when paired with perfusion imaging

Which are Technegas UNII Codes?

The UNII codes for the active 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.

[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.

[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".