FDA.reportPublic FDA data

5 ML daratumumab 20 MG/ML Injection

RxCUI
1721951
RxNorm name
5 ML daratumumab 20 MG/ML Injection
Display name
5 ML daratumumab 20 MG/ML Injection
Full name
5 ML daratumumab 20 MG/ML Injection
Term type
SCD
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#

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.

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 100 MG in 5 ML Injection [PSN] · 5 ML daratumumab 20 MG/ML Injection [SCD] · daratumumab 100 MG per 5 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