FDA.reportPublic FDA data

DANYELZA 40 MG in 10 ML Injection

RxCUI
2474244
RxNorm name
DANYELZA 40 MG in 10 ML Injection
Display name
DANYELZA 40 MG in 10 ML Injection
Full name
DANYELZA 40 MG in 10 ML Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:51

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761171Danyelzanaxitamab-gqgk351(a)Rx2026-09-01

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
DANYELZANAXITAMABBTG International Inc.b0f5ee96-369f-4cb9-a783-3bfa70fe8f902026-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2474244

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
29a80c6b-8bad-4650-8c7f-f18490c868ecDANYELZA 40 MG in 10 ML Injection [PSN] · 10 ML naxitamab-gqgk 4 MG/ML Injection [Danyelza] [SBD] · 10 ML Danyelza 4 MG/ML Injection [SY] · Danyelza 40 MG per 10 ML Injection [SY]49These highlights do not include all the information needed to use DANYELZA safely and effectively. See full prescribing information for DANYELZA. DANYELZA ® (naxitamab-gqgk) injection, for intravenous use Initial U.S. Approval: 202020250903