FDA.reportPublic FDA data

Phenoxybenzamine hydrochloride

Product NDC
69238-1502
11-digit product format
692381502
Labeler code
69238
Product ID
69238-1502_2b4f097e-fd61-43cb-b6ed-01fbf2868cf7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenoxybenzamine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA212568
Marketing category
ANDA
Marketing start
2020-10-30
Marketing end
0000-00-00
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
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69238-1502IInactivated by FDA2026-07-31
excluded packagepackage69238-150269238-1502-1IInactivated by FDA2026-07-31

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212568-001PHENOXYBENZAMINE HYDROCHLORIDEPHENOXYBENZAMINE HYDROCHLORIDE10MGCAPSULE / ORALAB2020-10-27

Therapeutic equivalence codes#

Application-product, TE code table
Application-productTE code
A212568-001AB

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 HYDROCHLORIDEAmneal Pharmaceuticals NY LLC0be6a394-cd10-42fc-97cf-ad53d81d8d932026-07-03Warnings, 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 Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
805d9e5d-594b-7d44-2033-963b5e3698baProduct name520240723
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69238-1502-12022-01-28C16284748780-1d6a99b3a-0070-a426-e053-dadaa90af4c2Phenoxybenzamine Hydrochloride Capsules, USP (10 mg) Rx only Adrenergic, alpha -receptor-blocking agent

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1502-1Phenoxybenzamine hydrochloride100 in 1 BOTTLECAPSULE1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1502PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE [AMNEAL PHARMACEUTICALS NY LLC]5Legacy NDC, 1 package rows20201220_1daacf09-355c-4e22-88b0-dcd1e18f13d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861402phenoxybenzamine HCl 10 MG Oral CapsulePSN1daacf09-355c-4e22-88b0-dcd1e18f13d25
861402phenoxybenzamine hydrochloride 10 MG Oral CapsuleSCD1daacf09-355c-4e22-88b0-dcd1e18f13d25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1502-169238150201100 CAPSULE in 1 BOTTLE (69238-1502-1) 100 capsule2020-10-300000-00-00NoNoCurrent