PHENOXYBENZAMINE HYDROCHLORIDE

Product NDC
35573-473
11-digit product format
355730473
Labeler code
35573
Product ID
35573-473_609aa41e-4cb5-4cdf-9137-f429c21b4fab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENOXYBENZAMINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Burel Pharmaceuticals, LLC
Application
ANDA215600
Marketing category
ANDA
Marketing start
2023-05-08
Substance
PHENOXYBENZAMINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A215600-001PHENOXYBENZAMINE HYDROCHLORIDEPHENOXYBENZAMINE HYDROCHLORIDE10MGCAPSULE / ORALAB2023-05-08

Therapeutic equivalence codes#

Application-product, TE code table
Application-productTE code
A215600-001AB

openFDA label cross-check#

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 table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHENOXYBENZAMINE HYDROCHLORIDEPHENOXYBENZAMINE HYDROCHLORIDEBurel Pharmaceuticals, LLC609aa41e-4cb5-4cdf-9137-f429c21b4fab2024-08-09Warnings, Adverse reactionsExact identifier

Warnings cross-check#

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

warnings

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 Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Additional Listing Data#

Finished product
Yes
Brand name base
PHENOXYBENZAMINE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENOXYBENZAMINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX1IEG24OHL
Rxcui861402

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
805d9e5d-594b-7d44-2033-963b5e3698baProduct name520240723

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35573-473-02PHENOXYBENZAMINE HYDROCHLORIDE100 in 1 BOTTLECAPSULE1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35573-473-02EA - Each35573-473238c4aa3-010f-4a38-a1a0-6692f00ca9e612025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35573-473PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE [BUREL PHARMACEUTICALS, LLC]1Current NDC, 1 package rows20250110_609aa41e-4cb5-4cdf-9137-f429c21b4fab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861402phenoxybenzamine HCl 10 MG Oral CapsulePSN609aa41e-4cb5-4cdf-9137-f429c21b4fab1
861402phenoxybenzamine hydrochloride 10 MG Oral CapsuleSCD609aa41e-4cb5-4cdf-9137-f429c21b4fab1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
35573-473-0235573047302100 CAPSULE in 1 BOTTLE (35573-473-02) 100 capsule2023-05-08NoNoCurrent