FDA.reportPublic FDA data

amivantamab-lpuj 1600 MG / hyaluronidase-lpuj 20000 UNT per 10 ML Injection

RxCUI
2729297
RxNorm name
amivantamab-lpuj 1600 MG / hyaluronidase-lpuj 20000 UNT per 10 ML Injection
Display name
amivantamab-lpuj 1600 MG / hyaluronidase-lpuj 20000 UNT per 10 ML Injection
Full name
amivantamab-lpuj 1600 MG / hyaluronidase-lpuj 20000 UNT per 10 ML Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:10

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761484Rybrevant Fasproamivantamab and hyaluronidase-lpuj351(a)Rx2026-06-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rybrevant FasproAMIVANTAMAB AND HYALURONIDASE-LPUJ (HUMAN RECOMBINANT)Janssen Biotech, Inc.9e58b045-e352-4f62-99bf-77fae1bebc692026-06-17Warnings, Adverse reactionsExact identifier
rxcui: 2729297

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
9e58b045-e352-4f62-99bf-77fae1bebc69amivantamab-lpuj 1600 MG / hyaluronidase-lpuj 20000 UNT per 10 ML InjectionSY4These highlights do not include all the information needed to use RYBREVANT FASPRO safely and effectively. See full prescribing information for RYBREVANT FASPRO. RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) injection, for subcutaneous use Initial U.S. Approval: 202520260218
9e58b045-e352-4f62-99bf-77fae1bebc6910 ML amivantamab-lpuj 160 MG/ML / hyaluronidase-lpuj 2000 UNT/ML InjectionSCD4These highlights do not include all the information needed to use RYBREVANT FASPRO safely and effectively. See full prescribing information for RYBREVANT FASPRO. RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) injection, for subcutaneous use Initial U.S. Approval: 202520260218
9e58b045-e352-4f62-99bf-77fae1bebc69amivantamab-lpuj 1600 MG / hyaluronidase-lpuj 20000 UNT in 10 ML InjectionPSN4These highlights do not include all the information needed to use RYBREVANT FASPRO safely and effectively. See full prescribing information for RYBREVANT FASPRO. RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) injection, for subcutaneous use Initial U.S. Approval: 202520260218