naxitamab-gqgk 40 MG per 10 ML Injection

RxCUI: 2474239
RxNorm name: naxitamab-gqgk 40 MG per 10 ML Injection
Display name: naxitamab-gqgk 40 MG per 10 ML Injection
Full name: naxitamab-gqgk 40 MG per 10 ML Injection
Term type: SY
Status: DailyMed mapping
Updated: 2026-06-04 23:38:51

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
761171	Danyelza	naxitamab-gqgk	351(a)	Rx	2026-06-01

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DANYELZA	NAXITAMAB	BTG International Inc.	b0f5ee96-369f-4cb9-a783-3bfa70fe8f90	2026-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 2474239

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set ID	RxNorm string	TTY	SPL version	Label	Effective
29a80c6b-8bad-4650-8c7f-f18490c868ec	naxitamab-gqgk 40 MG per 10 ML Injection	SY	9	These 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: 2020	20250903
29a80c6b-8bad-4650-8c7f-f18490c868ec	10 ML naxitamab-gqgk 4 MG/ML Injection	SCD	9	These 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: 2020	20250903
29a80c6b-8bad-4650-8c7f-f18490c868ec	naxitamab-gqgk 40 MG in 10 ML Injection	PSN	9	These 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: 2020	20250903