FDA.reportPublic FDA data

DANYELZA

Product NDC
73042-201
Requested package NDC
73042-201-01
11-digit product format
730420201
Labeler code
73042
Product ID
73042-201_117c2751-cc38-4d07-9d3c-339b2fe18916
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naxitamab
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Y-mAbs Therapeutics, Inc.
Application
BLA761171
Marketing category
BLA
Marketing start
2020-11-25
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage73042-20173042-201-01IInactivated by FDA2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f35ce0ea-74c7-431f-85f6-2e52a100a245Product name120210601
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73042-201-01DANYELZA10 mL in 1 VIAL, SINGLE-DOSEINJECTION109
73042-201-01DANYELZA1 in 1 CARTONINJECTION19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73042-201-01ML - Milliliter73042-201e04d1f23-8808-4a7b-8b53-3dbb0ca8979912021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73042-201DANYELZA (NAXITAMAB) INJECTION [Y-MABS THERAPEUTICS, INC.]8Legacy NDC, 2 package rows20250523_29a80c6b-8bad-4650-8c7f-f18490c868ec.zip

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
application number: BLA761171

Purple Book Biologic Products#

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2474244DANYELZA 40 MG in 10 ML InjectionPSN29a80c6b-8bad-4650-8c7f-f18490c868ec9
2474239naxitamab-gqgk 40 MG in 10 ML InjectionPSN29a80c6b-8bad-4650-8c7f-f18490c868ec9
247424410 ML naxitamab-gqgk 4 MG/ML Injection [Danyelza]SBD29a80c6b-8bad-4650-8c7f-f18490c868ec9
247423910 ML naxitamab-gqgk 4 MG/ML InjectionSCD29a80c6b-8bad-4650-8c7f-f18490c868ec9
247424410 ML Danyelza 4 MG/ML InjectionSY29a80c6b-8bad-4650-8c7f-f18490c868ec9
2474244Danyelza 40 MG per 10 ML InjectionSY29a80c6b-8bad-4650-8c7f-f18490c868ec9
2474239naxitamab-gqgk 40 MG per 10 ML InjectionSY29a80c6b-8bad-4650-8c7f-f18490c868ec9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
73042-201-01730420201011 VIAL, SINGLE-DOSE in 1 CARTON (73042-201-01) > 10 mL in 1 VIAL, SINGLE-DOSE2020-11-250000-00-00NoNoCurrent