PHENOXYBENZAMINE HYDROCHLORIDE

Product NDC
59651-327
11-digit product format
596510327
Labeler code
59651
Product ID
59651-327_3aeb0006-90e3-477a-9c81-0a8a671061d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENOXYBENZAMINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
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

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
unfinished productproduct59651-327UNFINISHEDActive or certified unfinished drug listing2026-07-31
unfinished packagepackage59651-32759651-327-09UNFINISHEDActive or certified unfinished drug listing2026-07-31

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 HYDROCHLORIDEAurobindo Pharma Limited75f26681-a079-4ff3-9fff-75526041374c2024-02-16Warnings, 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
59651-327-01PHENOXYBENZAMINE HYDROCHLORIDE100 in 1 BOTTLECAPSULE1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-327PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]2Current NDC, 1 package rows20240218_75f26681-a079-4ff3-9fff-75526041374c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861402phenoxybenzamine HCl 10 MG Oral CapsulePSN75f26681-a079-4ff3-9fff-75526041374c2
861402phenoxybenzamine hydrochloride 10 MG Oral CapsuleSCD75f26681-a079-4ff3-9fff-75526041374c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-327-0159651032701100 CAPSULE in 1 BOTTLE (59651-327-01) 100 capsule2023-05-08NoNoCurrent
59651-327-09596510327091200 CAPSULE in 1 BAG (59651-327-09)1200 capsule08-MAY-23Current