FDA.reportPublic FDA data

6.5 ML nipocalimab-aahu 185 MG/ML Injection

RxCUI
2712708
RxNorm name
6.5 ML nipocalimab-aahu 185 MG/ML Injection
Display name
6.5 ML nipocalimab-aahu 185 MG/ML Injection
Full name
6.5 ML nipocalimab-aahu 185 MG/ML Injection
Term type
SCD
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)Rx2026-06-01

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
IMAAVYNIPOCALIMAB-AAHUJanssen Biotech, Inc.8886274c-f2b2-48af-85c1-2f90bfe304b82025-05-07Warnings, Adverse reactionsExact identifier
rxcui: 2712708

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
8886274c-f2b2-48af-85c1-2f90bfe304b86.5 ML nipocalimab-aahu 185 MG/ML InjectionSCD4These 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
8886274c-f2b2-48af-85c1-2f90bfe304b8nipocalimab-aahu 1200 MG per 6.5 ML InjectionSY4These 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
8886274c-f2b2-48af-85c1-2f90bfe304b8nipocalimab-aahu 1,200 MG in 6.5 ML InjectionPSN4These 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