FDA.reportPublic FDA data

14 ML amivantamab-lpuj 160 MG/ML / hyaluronidase-lpuj 2000 UNT/ML Injection [Rybrevant Faspro]

RxCUI
2729307
RxNorm name
14 ML amivantamab-lpuj 160 MG/ML / hyaluronidase-lpuj 2000 UNT/ML Injection [Rybrevant Faspro]
Display name
14 ML amivantamab-lpuj 160 MG/ML / hyaluronidase-lpuj 2000 UNT/ML Injection [Rybrevant Faspro]
Full name
14 ML amivantamab-lpuj 160 MG/ML / hyaluronidase-lpuj 2000 UNT/ML Injection [Rybrevant Faspro]
Term type
SBD
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)Rx2026-08-01

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: 2729307

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
9e58b045-e352-4f62-99bf-77fae1bebc69Rybrevant Faspro 2240 MG / 28000 UNT in 14 ML Injection [PSN] · 14 ML amivantamab-lpuj 160 MG/ML / hyaluronidase-lpuj 2000 UNT/ML Injection [Rybrevant Faspro] [SBD] · Rybrevant Faspro (amivantamab-lpuj 2240 MG / hyaluronidase-lpuj 28000 UNT) per 14 ML Injection [SY] · Rybrevant Faspro 2240 MG / 28000 UNT per 14 ML Injection [SY]44These 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