Phenoxybenzamine hydrochloride
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
- Phenoxybenzamine hydrochloride
- Generic name
- PHENOXYBENZAMINE HYDROCHLORIDE
- Manufacturer
- Amneal Pharmaceuticals NY LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 0be6a394-cd10-42fc-97cf-ad53d81d8d93
- SPL ID
- 7e30ff83-c617-4830-b75e-1897242c3a1a
- Version
- 12
- Effective date
- 2026-07-03
- Source export date
- 2026-10-12
- 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/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:39:23
| Harmonized routes |
|---|
| ORAL |
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 | 212568 | derived:openfda.application_number |
| application number | ANDA212568 | openfda.application_number | |
| brand name | Phenoxybenzamine hydrochloride | openfda.brand_name | |
| generic name | PHENOXYBENZAMINE HYDROCHLORIDE | openfda.generic_name | |
| manufacturer name | Amneal Pharmaceuticals NY LLC | openfda.manufacturer_name | |
| ndc | package | 60219-1502-1 | openfda.package_ndc |
| ndc | product | 60219-1502 | openfda.product_ndc |
| ndc11 | package | 60219150201 | derived:openfda.package_ndc |
| rxcui | 861402 | openfda.rxcui | |
| spl id | 7e30ff83-c617-4830-b75e-1897242c3a1a | id | |
| spl set id | 0be6a394-cd10-42fc-97cf-ad53d81d8d93 | set_id | |
| unii | X1IEG24OHL | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNING Phenoxybenzamine hydrochloride-induced alpha -adrenergic blockade leaves beta -adrenergic receptors unopposed. Compounds that stimulate both types of receptors may, therefore, produce an exaggerated hypotensive response and tachycardia.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS The following adverse reactions have been observed, but there are insufficient data to support an estimate of their frequency. Autonomic Nervous System*: Postural hypotension, tachycardia, inhibition of ejaculation, nasal congestion, miosis. *These so-called “side effects” are actually evidence of adrenergic blockade and vary according to the degree of blockade. Miscellaneous: Gastrointestinal irritation, drowsiness, fatigue. To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.