Indium DTPA In 111

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)

Brand name: Indium DTPA In 111
Generic name: INDIUM IN-111 PENTETATE DISODIUM
Manufacturer: Medi-Physics, Inc. dba GE Healthcare
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 4fea5871-b515-4f69-a297-11507ddd7817
SPL ID: 3dfabc30-f669-4287-9948-038c3a502d1f
Version: 6
Effective date: 2024-01-10
Source export date: 2026-10-12
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:33:10

Harmonized routes table
Harmonized routes
INTRATHECAL

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 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	NDA	017707	derived:openfda.application_number
application number		NDA017707	openfda.application_number
brand name		Indium DTPA In 111	openfda.brand_name
generic name		INDIUM IN-111 PENTETATE DISODIUM	openfda.generic_name
manufacturer name		Medi-Physics, Inc. dba GE Healthcare	openfda.manufacturer_name
ndc	package	17156-251-08	openfda.package_ndc
ndc	product	17156-251	openfda.product_ndc
ndc11	package	17156025108	derived:openfda.package_ndc
spl id		3dfabc30-f669-4287-9948-038c3a502d1f	id
spl set id		4fea5871-b515-4f69-a297-11507ddd7817	set_id
unii		7UIT3ZGC8E	openfda.unii

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 The contents of the vial are radioactive. Adequate shielding of the preparation must be maintained at all times. Since the drug is excreted by the kidneys, caution should be exercised in patients with severely impaired renal function.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS Aseptic meningitis and pyrogenic reactions have been rarely (less than 0.4%) observed following cisternography with Pentetate lndium Disodium In 111. One death has been reported to have occurred within 20 minutes following the administration of Pentetate Indium Disodium In 111 and appears to be drug related. In addition, two cases of septic meningitis have also been reported. There have also been reports of skin reactions and vomiting following administration of Pentetate lndium Disodium In 111. Relationship of the drug to these latter occurrences has not been established.

Reported adverse events (FAERS/openFDA)#

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