| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PHENOXYBENZAMINE HYDROCHLORIDE | PHENOXYBENZAMINE HYDROCHLORIDE | CAPSULE;ORAL | 10MG | No | No |
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A215600-001 | PHENOXYBENZAMINE HYDROCHLORIDE | PHENOXYBENZAMINE HYDROCHLORIDE | 10MG | CAPSULE / ORAL | AB | 2023-05-08 |
| Application-product | TE code |
|---|---|
| A215600-001 | AB |
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| PHENOXYBENZAMINE HYDROCHLORIDE | PHENOXYBENZAMINE HYDROCHLORIDE | NorthStar Rx LLC | 48a047c0-f409-420b-990a-2cab953a96cd | 2026-07-09 | Warnings, Adverse reactions | |
| PHENOXYBENZAMINE HYDROCHLORIDE | PHENOXYBENZAMINE HYDROCHLORIDE | Burel Pharmaceuticals, LLC | 609aa41e-4cb5-4cdf-9137-f429c21b4fab | 2024-08-09 | Warnings, Adverse reactions | |
| PHENOXYBENZAMINE HYDROCHLORIDE | PHENOXYBENZAMINE HYDROCHLORIDE | Aurobindo Pharma Limited | 75f26681-a079-4ff3-9fff-75526041374c | 2024-02-16 | Warnings, Adverse reactions |
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.
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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 Northstar Rx LLC at 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.