{
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"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (57894-510-01) / 10 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "57894-0510-01",
"ProductNDC": "57894-510",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rybrevant Faspro",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Amivantamab And Hyaluronidase-lpuj (human Recombinant)",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20251217",
"EndMarketingDate": null,
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761433",
"LabelerName": "Janssen Biotech, Inc.",
"SubstanceName": "AMIVANTAMAB; HYALURONIDASE (HUMAN RECOMBINANT)",
"StrengthNumber": "1600; 20000",
"StrengthUnit": "mg/10mL; mg/10mL",
"Pharm_Classes": "Endoglycosidase [EPC], Glycoside Hydrolases [CS]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251217",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}