Prescription medicine
Phenoxybenzamine First approved as Dibenzyline
Phenoxybenzamine (Dibenzyline) is a prescription medicine with an FDA approval on record since 1953. FDA's NDC Directory lists it from 5 generic labelers.
- Generic listed
- A presentation discontinued
Check it at the source: the phenoxybenzamine FDA label on DailyMed (effective July 3, 2026, Amneal Pharmaceuticals NY LLC); the NDA 8708 record on Drugs@FDA; every phenoxybenzamine label on DailyMed.
Highlights of the record
FDA label of July 3, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usagePhenoxybenzamine hydrochloride capsules are indicated in the treatment of pheochromocytoma, to control episodes of hypertension and sweating.
Forms and strengths
- 10 mg
Capsule.
On the market
- Earliest approval on file
- January 26, 1953 Dibenzyline, Advanz Pharma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 6 first July 16, 2012; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 5 of which 5 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- None current 3 past records
- Recalls by its makers (FDA)
- 2 since 2022 0 Class I among all firms' recalls; latest January 15, 2024
- FAERS reports
- 26 through July 30, 2026
What is phenoxybenzamine used for?
From the label: indications and usagePhenoxybenzamine hydrochloride capsules are indicated in the treatment of pheochromocytoma, to control episodes of hypertension and sweating. If tachycardia is excessive, it may be necessary to use a beta -blocking agent concomitantly.
Conditions named in the indications of phenoxybenzamine's FDA labels, with every medicine labeled for each:
From other phenoxybenzamine labelsHigh blood pressure: INDICATION AND USAGE Phenoxybenzamine hydrochloride capsules are indicated in the treatment of pheochromocytoma, to control episodes of hypertension and sweating.
FDA pharmacologic class: alpha-Adrenergic Blocker.
Source: FDA drug label (Phenoxybenzamine hydrochloride), Amneal Pharmaceuticals NY LLC, effective July 3, 2026 (SPL set 0be6a394-cd10-42fc-97cf-ad53d81d8d93), via openFDA; the full label on DailyMed
Is there a generic for phenoxybenzamine (Dibenzyline)?
The FDA approved the first generic phenoxybenzamine on July 16, 2012. 6 generic applications are approved; 5 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists phenoxybenzamine from 5 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1953 earliest approval on file
- 2012 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is phenoxybenzamine in shortage?
No phenoxybenzamine presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 3 records are all marked to be discontinued, the latest updated December 1, 2025. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Dibenzyline, Capsule, 10 mg (NDC 59212-001-01) | Advanz Pharma (US) Corp. | To Be Discontinued | December 1, 2025 |
| Dibenzyline, Capsule, 10 mg (NDC 59212-001-02) | Advanz Pharma (US) Corp. | To Be Discontinued | December 1, 2025 |
| Dibenzyline, Capsule, 10 mg (NDC 66993-066-02) | Advanz Pharma (US) Corp. | To Be Discontinued | December 1, 2025 |
Every phenoxybenzamine presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has phenoxybenzamine been recalled?
The FDA's Enforcement Report lists 2 recalls naming phenoxybenzamine since 2022: 0 Class I (the most serious), 2 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| January 15, 2024 | Class II | Amneal Pharmaceuticals of New York, LLC | Failed Impurities/Degradation Specifications: Out of specification for unknown impurity. |
| November 10, 2022 | Class II | Par Formulations Private Limited | Failed Impurities/Degradation Specifications |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the phenoxybenzamine label say about other medicines?
The phenoxybenzamine label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Epinephrine | drug interactions | Drug Interactions 2 – Phenoxybenzamine hydrochloride may interact with compounds that stimulate both alpha- and beta- adrenergic receptors (i.e. epinephrine) to produce an exaggerated hypotensive response and tachycardia (see WARNING ). |
Source: FDA drug label (Phenoxybenzamine hydrochloride), Amneal Pharmaceuticals NY LLC, effective July 3, 2026 (SPL set 0be6a394-cd10-42fc-97cf-ad53d81d8d93), via openFDA; the full label on DailyMed
What do FAERS reports show for phenoxybenzamine?
The FDA Adverse Event Reporting System holds 26 reports that list phenoxybenzamine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 12 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as phenoxybenzamine?
75 other medicines are given the same way (oral) and in the same FDA class as phenoxybenzamine or labeled mainly for the same use (high blood pressure), the same class first. High blood pressure lists all 88 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Carvedilol | High blood pressure | 41 labelers | $0.0179 per tablet 6.25 mg tablet | No current entry |
| Doxazosin | High blood pressure | 29 labelers | $0.0752 per tablet 1 mg tablet | No current entry |
| Prazosin | High blood pressure | 33 labelers | $0.0842 per capsule 1 mg capsule | A presentation being discontinued |
| Terazosin | High blood pressure | 21 labelers | $0.106 per capsule 2 mg capsule | No current entry |
| Metoprolol | High blood pressure | 64 labelers | $0.085 per tablet 100 mg tablet | A presentation being discontinued |
| Diltiazem | High blood pressure | 42 labelers | $0.144 per capsule 24h ER(cd) 120 mg capsule | A presentation being discontinued |
| Lisinopril | High blood pressure | 36 labelers | $0.0254 per tablet 20 mg tablet | No current entry |
| Propranolol | High blood pressure | 38 labelers | $0.0493 per tablet 20 mg tablet | In shortage |
Every medicine labeled for the same conditions as phenoxybenzamine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to phenoxybenzamine
- 75 medicines for the same use
- Other alpha blockers
- the pharmacologic class, with prices and generics
- Phenoxybenzamine side effects
- the label's list beside FAERS reports
- Phenoxybenzamine shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other