NDC 69945-097

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 ID: 69945-097_3760d200-b48e-46ea-975f-6b17a6d8d8a3
• NDC: 69945-097
• Product Type: Human Prescription Drug
• Proprietary Name: Xenon, Xe-133
• Generic Name: Xenon
• Dosage Form: Gas
• Route of Administration: RESPIRATORY (INHALATION)
• Marketing Start Date: 2016-03-30
• Marketing Category: NDA / NDA
• Application Number: NDA018327
• Labeler Name: Curium US LLC
• Substance Name: XENON XE-133
• Active Ingredient Strength: 5 mCi/mL
• Pharm Classes: Inhalation Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 69945-097-11

1 CAN in 1 CONTAINER (69945-097-11) > 1 BOTTLE in 1 CAN > 2 mL in 1 BOTTLE

• Marketing Start Date: 2016-03-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69945-097-15 [69945009715]

Xenon, Xe-133 GAS

• Marketing Category: NDA
• Application Number: NDA018327
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-03-30

NDC 69945-097-13 [69945009713]

Xenon, Xe-133 GAS

• Marketing Category: NDA
• Application Number: NDA018327
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-03-30

NDC 69945-097-11 [69945009711]

Xenon, Xe-133 GAS

• Marketing Category: NDA
• Application Number: NDA018327
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-03-30

Drug Details

Active Ingredients

Ingredient	Strength
XENON XE-133	5 mCi/mL

OpenFDA Data

• SPL SET ID: 5eb971be-8808-4aeb-9898-0d22d5dffe04
• Manufacturer:
  • Curium US LLC
• UNII:
  • X3P9A5HNYF

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
69945-097	Xenon, Xe-133	Xenon
69945-098	Xenon, Xe-133	Xenon