Xenon, Xe-133
Xenon Xe 133 GasRx only Diagnostic
Approved
Approval ID
5eb971be-8808-4aeb-9898-0d22d5dffe04
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2022
Manufacturers
FDA
Curium US LLC
DUNS: 079875617
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Xenon
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69945-097
Application NumberNDA018327
Product Classification
M
Marketing Category
C73594
G
Generic Name
Xenon
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateDecember 15, 2022
FDA Product Classification
INGREDIENTS (2)
XENON XE-133Active
Quantity: 5 mCi in 1 mL
Code: X3P9A5HNYF
Classification: ACTIB
AIRInactive
Code: K21NZZ5Y0B
Classification: IACT
Xenon
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69945-098
Application NumberNDA018327
Product Classification
M
Marketing Category
C73594
G
Generic Name
Xenon
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateDecember 15, 2022
FDA Product Classification
INGREDIENTS (2)
XENON XE-133Active
Quantity: 10 mCi in 1 mL
Code: X3P9A5HNYF
Classification: ACTIB
AIRInactive
Code: K21NZZ5Y0B
Classification: IACT