Phentolamine Mesylate
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
- Phentolamine Mesylate
- Generic name
- PHENTOLAMINE MESYLATE
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- ed6c506c-5535-4b7c-ae1a-d63f09d796c9
- SPL ID
- 264ee71e-7e33-4693-b993-8ee0cc2f8d48
- Version
- 9
- Effective date
- 2024-03-13
- Source export date
- 2026-09-28
- Source partition
- 4
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:24:06
| Harmonized routes |
|---|
| INTRAMUSCULAR, 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 | 040235 | derived:openfda.application_number |
| application number | ANDA040235 | openfda.application_number | |
| brand name | Phentolamine Mesylate | openfda.brand_name | |
| generic name | PHENTOLAMINE MESYLATE | openfda.generic_name | |
| manufacturer name | Hikma Pharmaceuticals USA Inc. | openfda.manufacturer_name | |
| ndc | package | 0143-9564-01 | openfda.package_ndc |
| ndc | package | 0143-9564-10 | openfda.package_ndc |
| ndc | product | 0143-9564 | openfda.product_ndc |
| ndc11 | package | 00143956401 | derived:openfda.package_ndc |
| ndc11 | package | 00143956410 | derived:openfda.package_ndc |
| rxcui | 1361023 | openfda.rxcui | |
| spl id | 264ee71e-7e33-4693-b993-8ee0cc2f8d48 | id | |
| spl set id | ed6c506c-5535-4b7c-ae1a-d63f09d796c9 | set_id | |
| unii | Y7543E5K9T | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Myocardial infarction, cerebrovascular spasm, and cerebrovascular occlusion have been reported to occur following the administration of phentolamine, usually in association with marked hypotensive episodes. For screening tests in patients with hypertension, the generally available urinary assay of catecholamines or other biochemical assays have largely replaced the phentolamine and other pharmacological tests for reasons of accuracy and safety. None of the chemical or pharmacological tests is infallible in the diagnosis of pheochromocytoma. The phentolamine blocking test is not the procedure of choice and should be reserved for cases in which additional confirmatory evidence is necessary and the relative risks involved in conducting the test have been considered.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Acute and prolonged hypotensive episodes, tachycardia, and cardiac arrhythmias have been reported. In addition, weakness, dizziness, flushing, orthostatic hypotension, nasal stuffiness, nausea, vomiting, and diarrhea may occur.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.