Home FDA labels f88c1028-afc6-4b57-80e8-386ee541b355 FDA label f88c1028-afc6-4b57-80e8-386ee541b355 openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)
SPL set ID 23298d65-1dc8-4237-9075-99d3b01bd963
SPL ID f88c1028-afc6-4b57-80e8-386ee541b355
Version 4
Effective date 2011-12-31
Source export date 2026-10-12
Source partition 13
Source file https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 03:03:02 Harmonized identifier links# Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
Harmonized identifiers page 1 of 1 · 2 matching rows.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings WARNINGS CONTENTS OF THE VIAL OF INDIUM In 111 CHLORIDE SOLUTION ARE INTENDED ONLY TO BE USED AS AN INGREDIENT FOR RADIOLABELING PROSTASCINT FOR USE IN IN VIVO DIAGNOSTIC IMAGING PROCEDURES OR TO BE USED AS AN INGREDIENT FOR RADIOLABELING ZEVALIN™ FOR USE IN RADIOIMMUNOTHERAPY PROCEDURES, AND ARE NOT TO BE ADMINISTERED DIRECTLY TO HUMANS.
Adverse reactions cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions sections page 1 of 1 · 1 matching rows.
adverse reactions ADVERSE REACTIONS Please refer to the package insert for ProstaScint or Zevalin for this information on the final drug product.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.