FDA.reportPublic FDA data

DARZALEX 100 MG in 5 ML Injection

RxCUI
1721956
RxNorm name
DARZALEX 100 MG in 5 ML Injection
Display name
DARZALEX 100 MG in 5 ML Injection
Full name
DARZALEX 100 MG in 5 ML Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:12

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761036Darzalexdaratumumab351(a)Rx2026-08-01

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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No records found.

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
a4d0efe9-5e54-467e-9eb4-56fa7d53b60bDARZALEX 100 MG in 5 ML Injection [PSN] · 5 ML daratumumab 20 MG/ML Injection [Darzalex] [SBD] · 5 ML Darzalex 20 MG/ML Injection [SY] · Darzalex 100 MG per 5 ML Injection [SY]443These highlights do not include all the information needed to use DARZALEX safely and effectively. See full prescribing information for DARZALEX. DARZALEX ® (daratumumab) injection, for intravenous use Initial U.S. Approval: 201520251117