Indium In 111 Oxyquinoline
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
- Brand name
- Indium In 111 Oxyquinoline
- Generic name
- INDIUM IN-111 OXYQUINOLINE
- Manufacturer
- BWXT Medical Ltd.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 7dbfc0f9-0e2e-4aed-85bd-32cf7c74d402
- SPL ID
- 0864f662-e3ce-4426-8c3c-e318f755a89d
- Version
- 4
- Effective date
- 2024-11-01
- Source export date
- 2026-09-28
- Source partition
- 7
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:44:46
| Harmonized routes |
|---|
| INTRAVENOUS |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | ANDA | 202586 | derived:openfda.application_number |
| application number | ANDA202586 | openfda.application_number | |
| brand name | Indium In 111 Oxyquinoline | openfda.brand_name | |
| generic name | INDIUM IN-111 OXYQUINOLINE | openfda.generic_name | |
| manufacturer name | BWXT Medical Ltd. | openfda.manufacturer_name | |
| ndc | package | 72536-0920-1 | openfda.package_ndc |
| ndc | product | 72536-0920 | openfda.product_ndc |
| ndc11 | package | 72536092001 | derived:openfda.package_ndc |
| spl id | 0864f662-e3ce-4426-8c3c-e318f755a89d | id | |
| spl set id | 7dbfc0f9-0e2e-4aed-85bd-32cf7c74d402 | set_id | |
| unii | LGX9OL562T | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS The content of the vial of indium In 111 oxyquinoline solution is intended only for use in the preparation of indium In 111 oxyquinoline labeled autologous leukocytes, and is not to be administered directly. Autologous leukocyte labeling is not recommended in leukopenic patients because of the small number of available leukocytes. Due to radiation exposure, indium In 111 oxyquinoline labeled leukocytes could cause fetal harm when administered to pregnant women. If this radiopharmaceutical is used during pregnancy, the patient should be informed of the potential hazard to the fetus. Indium In 111 oxyquinoline labeled autologous leukocytes should be used only when the benefit to be obtained exceeds the risks involved in children under eighteen years of age owing to the high radiation burden and the potential for delayed manifestation of long-term adverse effects.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Sensitivity reactions (urticaria) have been reported. The presence of fever may mask pyrogenic reactions from indium In 111 oxyquinoline labeled leukocytes. The possibility of delayed adverse reactions has not been studied.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.