69945-098 NDC - XENON, XE-133 (XENON)

Drug Information

Product NDC: 69945-098

Proprietary Name: Xenon, Xe-133

Non Proprietary Name: Xenon

Active Ingredient(s):
  • 10 mCi/mL XENON XE-133


Administration Route(s): RESPIRATORY (INHALATION)

Dosage Form(s): GAS

Pharmacy Class(es):
  • Inhalation Diagnostic Agent [EPC];
  • Radiopharmaceutical Activity [MoA]

Labeler Information

Labeler Name: Curium US LLC
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA018327
Marketing Category: NDA
Start Marketing Date:3/30/2016

Package Information

No. Package Code Package Description Billing Unit
169945-098-211 CAN in 1 CONTAINER (69945-098-21) / 1 BOTTLE in 1 CAN / 2 mL in 1 BOTTLE
269945-098-233 CAN in 1 CONTAINER (69945-098-23) / 1 BOTTLE in 1 CAN / 2 mL in 1 BOTTLE
369945-098-255 CAN in 1 CONTAINER (69945-098-25) / 1 BOTTLE in 1 CAN / 2 mL in 1 BOTTLE

NDC Record

Field Name Field Value Definition
PRODUCT NDC69945-098The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates 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.
PROPRIETARY NAMEXenon, Xe-133The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEXenonThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEGASThe translation of the dosage form Code submitted by the firm.
ROUTE NAMERESPIRATORY (INHALATION)The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE3/30/2016This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct 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.
APPLICATION NUMBERNDA018327This 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.
LABELER NAMECurium US LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEXENON XE-133An 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.
ACTIVE NUMERATOR STRENGTH10 
ACTIVE INGRED UNITmCi/mL 
PHARM CLASSESInhalation Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA] 

Download Record

Download this NDC record in Text format: Export

Download this NDC record in Excel (CSV) format: Export

Download this NDC record in XML format: Export

This page was last updated on: 2/1/2023