Home NDC 50633-230 DANYELZA
Product NDC 50633-230
11-digit product format 506330230
Labeler code 50633
Product ID 50633-230_52bb5505-85d0-256a-e063-6294a90a73a8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Naxitamab
Dosage form INJECTION
Route INTRAVENOUS
Labeler BTG International 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]
Listing certified through 2027-12-31
Current FDA listing Yes 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.
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.
DailyMed Product Concepts# 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