"80534-0500-1" National Drug Code (NDC)

Xenoview 50 BAG in 1 CARTON (80534-0500-1) / 500 mL in 1 BAG
(Polarean, Inc.)

NDC Code80534-0500-1
Package Description50 BAG in 1 CARTON (80534-0500-1) / 500 mL in 1 BAG
Product NDC80534-0500
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameXenoview
Non-Proprietary NameXenon Xe 129 Hyperpolarized
Dosage FormGAS
UsageRESPIRATORY (INHALATION)
Start Marketing Date20221223
Marketing Category NameNDA
Application NumberNDA214375
ManufacturerPolarean, Inc.
Substance NameXENON XE-129, HYPERPOLARIZED
Strength75
Strength UnitmL/500mL
Pharmacy ClassesHyperpolarized Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]

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