United States · FDA National Drug Code directory

DANYELZA

A source-listed medicine record.

Factual source checks only. This page is not a clinically reviewed monograph. Historical or discontinued records may be included; listing does not confirm approval, current availability or pharmacy stock.

Medicine identity

Source reference
50633-230_5878035d-081a-1653-e063-6394a90af965
Product NDC
50633-230
Form
INJECTION
Composition / generic term
Naxitamab
Labeler
BTG International Inc.
Marketing category
BLA
Marketing start / end (source format)
20260901
Source listing expiry
20271231

Source-listed ingredients

  • NAXITAMAB — 40 mg/10mL

These values do not establish equivalence or a dose recommendation.

Packages

  • 1 VIAL, SINGLE-DOSE in 1 CARTON (50633-230-01) / 10 mL in 1 VIAL, SINGLE-DOSE · 50633-230-01

Source and coverage

Open FDA National Drug Code directory

Snapshot retrieved: 2026-09-17. This is the acquisition date, not a medical review date.

Clinical information, images and comparisons appear only when separately reviewed for this record. Coverage may be incomplete. Ask a pharmacist or clinician about your treatment.

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