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)Rx2026-06-01

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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DARZALEXDARATUMUMABJanssen Biotech, Inc.a4d0efe9-5e54-467e-9eb4-56fa7d53b60b2026-06-05Warnings, Adverse reactionsExact identifier
rxcui: 1721956

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
a4d0efe9-5e54-467e-9eb4-56fa7d53b60bDARZALEX 100 MG in 5 ML InjectionPSN43These 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
a4d0efe9-5e54-467e-9eb4-56fa7d53b60b5 ML daratumumab 20 MG/ML Injection [Darzalex]SBD43These 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
a4d0efe9-5e54-467e-9eb4-56fa7d53b60bDarzalex 100 MG per 5 ML InjectionSY43These 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
a4d0efe9-5e54-467e-9eb4-56fa7d53b60b5 ML Darzalex 20 MG/ML InjectionSY43These 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