DANYELZA

Product NDC: 50633-230
11-digit product format: 506330230
Labeler code: 50633
Product ID: 50633-230_5878035d-081a-1653-e063-6394a90af965
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naxitamab
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: BTG International Inc.
Application: BLA761171
Marketing category: BLA
Marketing start: 2026-09-01
Substance: NAXITAMAB
Active strength: 40 mg/10mL
Pharmacologic classes: Glycolipid Disialoganglioside-directed Antibody Interactions [MoA], Glycolipid Disialoganglioside-directed Antibody [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: DANYELZA
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NAXITAMAB	40 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9K8GNJ2874	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2474239	Internal RxNorm lookup
2474244	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
b0f5ee96-369f-4cb9-a783-3bfa70fe8f90	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f35ce0ea-74c7-431f-85f6-2e52a100a245	Product name	1	20210601

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
DANYELZA	NAXITAMAB	BTG International Inc.	b0f5ee96-369f-4cb9-a783-3bfa70fe8f90	2026-08-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA761171 ndc (product): 50633-230

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	2026-09-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9K8GNJ2874	NAXITAMAB	1879925-92-4	NAXITAMAB

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
50633-230-01	50633023001	1 VIAL, SINGLE-DOSE in 1 CARTON (50633-230-01) / 10 mL in 1 VIAL, SINGLE-DOSE	2026-09-01	No	No	Current