warnings
WARNINGS None known.
NEUROLITE
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
- NEUROLITE
- Generic name
- BICISATE DIHYDROCHLORIDE
- Manufacturer
- Lantheus Medical Imaging, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- f9adbcd5-1ac1-42d8-b18a-a76c9204014c
- SPL ID
- 6a6da20d-b33c-4e9e-98da-8d9b7cc963ca
- Version
- 12
- Effective date
- 2022-11-18
- Source export date
- 2026-09-28
- Source partition
- 6
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:43:03
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 | NDA | 020256 | derived:openfda.application_number |
| application number | NDA020256 | openfda.application_number | |
| brand name | NEUROLITE | openfda.brand_name | |
| generic name | BICISATE DIHYDROCHLORIDE | openfda.generic_name | |
| manufacturer name | Lantheus Medical Imaging, Inc. | openfda.manufacturer_name | |
| ndc | package | 11994-006-05 | openfda.package_ndc |
| ndc | package | 11994-006-02 | openfda.package_ndc |
| ndc | package | 11994-004-01 | openfda.package_ndc |
| ndc | package | 11994-002-01 | openfda.package_ndc |
| ndc | product | 11994-006 | openfda.product_ndc |
| ndc11 | package | 11994000201 | derived:openfda.package_ndc |
| ndc11 | package | 11994000602 | derived:openfda.package_ndc |
| ndc11 | package | 11994000605 | derived:openfda.package_ndc |
| ndc11 | package | 11994000401 | derived:openfda.package_ndc |
| spl id | 6a6da20d-b33c-4e9e-98da-8d9b7cc963ca | id | |
| spl set id | f9adbcd5-1ac1-42d8-b18a-a76c9204014c | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS In clinical trials, Neurolite has been administered to 1063 subjects (255 normals, 808 patients). Of these, 566 (53%) were men and 494 (47%) were women. The mean age was 58 years (range 17 to 92 years). In the 808 patients, who had experienced neurologic events, there were 11 (1.4%) deaths, none of which were clearly attributed to Neurolite. A total of 60 subjects experienced adverse reactions; the adverse reaction rates were comparable in the <65 year, and the >65 year age groups. The following adverse effects were observed in ≤ 1% of the subjects: headache, dizziness, seizure, agitation/anxiety, malaise/somnolence, parosmia, hallucinations, rash, nausea, syncope, cardiac failure, hypertension, angina, and apnea/cyanosis. In clinical trials of 197 patients, there were inconsistent changes in the serum calcium and phosphate levels. The cause of the changes has not been identified and their frequency and magnitude have not been clearly characterized. None of the changes required medical intervention.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.