FDA.reportPublic FDA data

daratumumab-fihj 1800 MG / hyaluronidase-fihj 30,000 UNT per 15 mL Injection

RxCUI
2375136
RxNorm name
daratumumab-fihj 1800 MG / hyaluronidase-fihj 30,000 UNT per 15 mL Injection
Display name
daratumumab-fihj 1800 MG / hyaluronidase-fihj 30,000 UNT per 15 mL Injection
Full name
daratumumab-fihj 1800 MG / hyaluronidase-fihj 30,000 UNT per 15 mL Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:57

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761145Darzalex Fasprodaratumumab and hyaluronidase-fihj351(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.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Darzalex FasproDARATUMUMAB AND HYALURONIDASE-FIHJ (HUMAN RECOMBINANT)Janssen Biotech, Inc.4bb241af-4299-4373-8762-2d6709515db02026-09-03Warnings, Adverse reactionsExact identifier
rxcui: 2375136

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
4bb241af-4299-4373-8762-2d6709515db0daratumumab-fihj 1800 MG / hyaluronidase-fihj 30,000 UNT in 15 mL Injection [PSN] · 15 ML daratumumab-fihj 120 MG/ML / hyaluronidase-fihj 2000 UNT/ML Injection [SCD] · daratumumab-fihj 1800 MG / hyaluronidase-fihj 30,000 UNT per 15 mL Injection [SY]331These highlights do not include all the information needed to use DARZALEX FASPRO safely and effectively. See full prescribing information for DARZALEX FASPRO. DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj) injection, for subcutaneous use Initial U.S. Approval: 202020260211