FDA.reportPublic FDA data

15 ML amivantamab-lpuj 160 MG/ML / hyaluronidase-lpuj 2000 UNT/ML Injection

RxCUI
2735796
RxNorm name
15 ML amivantamab-lpuj 160 MG/ML / hyaluronidase-lpuj 2000 UNT/ML Injection
Display name
15 ML amivantamab-lpuj 160 MG/ML / hyaluronidase-lpuj 2000 UNT/ML Injection
Full name
15 ML amivantamab-lpuj 160 MG/ML / hyaluronidase-lpuj 2000 UNT/ML Injection
Term type
SCD
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: 2735796

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
9e58b045-e352-4f62-99bf-77fae1bebc6915 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 2400 MG / hyaluronidase-lpuj 30000 UNT per 15 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-77fae1bebc69amivantamab-lpuj 2400 MG / hyaluronidase-lpuj 30000 UNT in 15 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