FDA.reportPublic FDA data

daratumumab 400 MG per 20 ML Injection

RxCUI
1726439
RxNorm name
daratumumab 400 MG per 20 ML Injection
Display name
daratumumab 400 MG per 20 ML Injection
Full name
daratumumab 400 MG per 20 ML Injection
Term type
SY
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#

UNII substance links page 1 of 1 · 0 matching rows.

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-9eb4-56fa7d53b60bdaratumumab 400 MG in 20 ML Injection [PSN] · 20 ML daratumumab 20 MG/ML Injection [SCD] · daratumumab 400 MG per 20 ML Injection [SY]343These 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