"85347-001-01" National Drug Code (NDC)

Piflufolastat F-18 50 mL in 1 VIAL, GLASS (85347-001-01)
(Aphelion LLC)

NDC Code85347-001-01
Package Description50 mL in 1 VIAL, GLASS (85347-001-01)
Product NDC85347-001
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NamePiflufolastat F-18
Non-Proprietary NamePiflufolastat F-18
Dosage FormINJECTION
UsageINTRAVENOUS
Start Marketing Date20260701
Marketing Category NameNDA
Application NumberNDA220089
ManufacturerAphelion LLC
Substance NamePIFLUFOLASTAT F-18
Strength120
Strength UnitmCi/mL
Pharmacy ClassesPositron Emitting Activity [MoA], Radioactive Diagnostic Agent [EPC]

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