FDA.reportPublic FDA data

Darzalex 400 MG in 20 ML Injection

RxCUI
1726440
RxNorm name
Darzalex 400 MG in 20 ML Injection
Display name
Darzalex 400 MG in 20 ML Injection
Full name
Darzalex 400 MG in 20 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: 1726440

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
a4d0efe9-5e54-467e-9eb4-56fa7d53b60bDarzalex 400 MG in 20 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-9eb4-56fa7d53b60bDarzalex 400 MG per 20 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-9eb4-56fa7d53b60b20 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
a4d0efe9-5e54-467e-9eb4-56fa7d53b60b20 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