XENOVIEW
These highlights do not include all the information needed to use XENOVIEW safely and effectively. See full prescribing information for XENOVIEW.XENOVIEW (xenon Xe 129 hyperpolarized), for oral inhalation
Approved
Approval ID
70e33fe3-c722-439b-b3db-c2a22f229c8a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 30, 2022
Manufacturers
FDA
Polarean, Inc.
DUNS: 078629330
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
xenon Xe 129 hyperpolarized
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code80534-1000
Application NumberNDA214375
Product Classification
M
Marketing Category
C73594
G
Generic Name
xenon Xe 129 hyperpolarized
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateJanuary 4, 2023
FDA Product Classification
INGREDIENTS (1)
XENON XE-129, HYPERPOLARIZEDActive
Quantity: 75 mL in 1 L
Code: 726Q6M95ZA
Classification: ACTIB
xenon Xe 129 hyperpolarized
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code80534-6350
Application NumberNDA214375
Product Classification
M
Marketing Category
C73594
G
Generic Name
xenon Xe 129 hyperpolarized
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateJanuary 4, 2023
FDA Product Classification
INGREDIENTS (3)
XENON XE-129Active
Quantity: 63.5 L in 1 1
Code: 9C7571UDT5
Classification: ACTIB
NITROGENActive
Quantity: 635 L in 1 1
Code: N762921K75
Classification: ACTIB
HELIUMActive
Quantity: 5651.5 L in 1 1
Code: 206GF3GB41
Classification: ACTIB