FDA.reportPublic FDA data

nipocalimab-aahu 300 MG per 1.62 ML Injection

RxCUI
2712699
RxNorm name
nipocalimab-aahu 300 MG per 1.62 ML Injection
Display name
nipocalimab-aahu 300 MG per 1.62 ML Injection
Full name
nipocalimab-aahu 300 MG per 1.62 ML Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:07

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761430Imaavynipocalimab-aahu351(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
IMAAVYNIPOCALIMAB-AAHUJanssen Biotech, Inc.8886274c-f2b2-48af-85c1-2f90bfe304b82026-08-21Warnings, Adverse reactionsExact identifier
rxcui: 2712699

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
8886274c-f2b2-48af-85c1-2f90bfe304b8nipocalimab-aahu 300 MG in 1.62 ML Injection [PSN] · 1.62 ML nipocalimab-aahu 185 MG/ML Injection [SCD] · nipocalimab-aahu 300 MG per 1.62 ML Injection [SY]34These highlights do not include all the information needed to use IMAAVY safely and effectively. See full prescribing information for IMAAVY. IMAAVY™ (nipocalimab-aahu) injection, for intravenous use Initial U.S. Approval: 202520250507