NDC 69945-098

Xenon, Xe-133

Xenon

Xenon, Xe-133 is a Respiratory (inhalation) Gas in the Human Prescription Drug category. It is labeled and distributed by Curium Us Llc. The primary component is Xenon Xe-133.

Product ID69945-098_3760d200-b48e-46ea-975f-6b17a6d8d8a3
NDC69945-098
Product TypeHuman Prescription Drug
Proprietary NameXenon, Xe-133
Generic NameXenon
Dosage FormGas
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2016-03-30
Marketing CategoryNDA / NDA
Application NumberNDA018327
Labeler NameCurium US LLC
Substance NameXENON XE-133
Active Ingredient Strength10 mCi/mL
Pharm ClassesInhalation Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 69945-098-21

1 CAN in 1 CONTAINER (69945-098-21) > 1 BOTTLE in 1 CAN > 2 mL in 1 BOTTLE
Marketing Start Date2016-03-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69945-098-25 [69945009825]

Xenon, Xe-133 GAS
Marketing CategoryNDA
Application NumberNDA018327
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-03-30

NDC 69945-098-23 [69945009823]

Xenon, Xe-133 GAS
Marketing CategoryNDA
Application NumberNDA018327
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-03-30

NDC 69945-098-21 [69945009821]

Xenon, Xe-133 GAS
Marketing CategoryNDA
Application NumberNDA018327
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-03-30

Drug Details

Active Ingredients

IngredientStrength
XENON XE-13310 mCi/mL

OpenFDA Data

SPL SET ID:5eb971be-8808-4aeb-9898-0d22d5dffe04
Manufacturer
UNII

Pharmacological Class

  • Inhalation Diagnostic Agent [EPC]
  • Radiopharmaceutical Activity [MoA]

NDC Crossover Matching brand name "Xenon, Xe-133" or generic name "Xenon"

NDCBrand NameGeneric Name
69945-097Xenon, Xe-133Xenon
69945-098Xenon, Xe-133Xenon

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