FDA.reportPublic FDA data

DANYELZA

Product NDC
73042-201
11-digit product format
730420201
Labeler code
73042
Product ID
73042-201_75b08b15-496c-4b4c-bf71-f0220b0d58b3
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
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
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct73042-201IInactivated by FDA2026-07-31
excluded packagepackage73042-20173042-201-01IInactivated by FDA2026-07-31

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DANYELZANAXITAMABBTG International Inc.b0f5ee96-369f-4cb9-a783-3bfa70fe8f902026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761171

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.]8Current NDC, Legacy NDC, 2 package rows20250523_29a80c6b-8bad-4650-8c7f-f18490c868ec.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761171Danyelzanaxitamab-gqgk351(a)Rx2026-06-01

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