5 ML dinutuximab 3.5 MG/ML Injection

RxCUI: 1606278
RxNorm name: 5 ML dinutuximab 3.5 MG/ML Injection
Display name: 5 ML dinutuximab 3.5 MG/ML Injection
Full name: 5 ML dinutuximab 3.5 MG/ML Injection
Term type: SCD
Status: DailyMed mapping
Updated: 2026-06-04 23:39:23

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125516	Unituxin	dinutuximab	351(a)	Rx	2026-08-01

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Unituxin	DINUTUXIMAB	United Therapeutics Corporation	d66bdf0d-9d65-45de-ae5b-a58617c27492	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1606278

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 ID	RxNorm mappings	Terms	SPL version	Label	Effective
d66bdf0d-9d65-45de-ae5b-a58617c27492	dinutuximab 17.5 MG in 5 ML Injection [PSN] · 5 ML dinutuximab 3.5 MG/ML Injection [SCD] · dinutuximab 17.5 MG per 5 ML Injection [SY]	3	13	These highlights do not include all the information needed to use UNITUXIN safely and effectively. See Full Prescribing Information for UNITUXIN. UNITUXIN ® (dinutuximab) injection, for intravenous use Initial U.S. Approval: 2015	20251021