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 (canonical bytes are SHA-256 checked before publication)

Brand name: Phenoxybenzamine Hydrochloride
Generic name: PHENOXYBENZAMINE HYDROCHLORIDE
Manufacturer: Novitium Pharma LLC
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 2cb5fcd7-c37f-41de-8beb-0c7eded9ed04
SPL ID: 235c3c98-4dc2-4b5e-8bdc-f21d18cbb7ac
Version: 2
Effective date: 2022-10-18
Source export date: 2026-10-12
Source partition: 1
Source file: https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:26:48

Harmonized routes table
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.

Harmonized identifiers page 1 of 1 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	215042	derived:openfda.application_number
application number		ANDA215042	openfda.application_number
brand name		Phenoxybenzamine Hydrochloride	openfda.brand_name
generic name		PHENOXYBENZAMINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		Novitium Pharma LLC	openfda.manufacturer_name
ndc	package	70954-365-10	openfda.package_ndc
ndc	product	70954-365	openfda.product_ndc
ndc11	package	70954036510	derived:openfda.package_ndc
rxcui		861402	openfda.rxcui
spl id		235c3c98-4dc2-4b5e-8bdc-f21d18cbb7ac	id
spl set id		2cb5fcd7-c37f-41de-8beb-0c7eded9ed04	set_id
unii		X1IEG24OHL	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS 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#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

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 Novitium Pharma, LLC at 1-855-204-1431 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.