Xenon
XENON Xe 133 GAS FOR DIAGNOSTIC USE
Approved
Approval ID
35bdc182-2a41-41d2-8fe7-aa0c140d4425
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 28, 2022
Manufacturers
FDA
Lantheus Medical Imaging, Inc.
DUNS: 176786812
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Xenon XE-133
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code11994-128
Application NumberNDA017284
Product Classification
M
Marketing Category
C73594
G
Generic Name
Xenon XE-133
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateNovember 28, 2022
FDA Product Classification
INGREDIENTS (2)
XENON XE-133Active
Quantity: 20 mCi in 1 1
Code: X3P9A5HNYF
Classification: ACTIB
CARBON DIOXIDEInactive
Code: 142M471B3J
Classification: IACT
Xenon XE-133
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code11994-127
Application NumberNDA017284
Product Classification
M
Marketing Category
C73594
G
Generic Name
Xenon XE-133
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateNovember 28, 2022
FDA Product Classification
INGREDIENTS (2)
XENON XE-133Active
Quantity: 10 mCi in 1 1
Code: X3P9A5HNYF
Classification: ACTIB
CARBON DIOXIDEInactive
Code: 142M471B3J
Classification: IACT