FDA.reportPublic FDA data

Phenoxybenzamine hydrochloride

Product NDC
69238-1502
Requested package NDC
69238-1502-1
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. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

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

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

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

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A212568-001PHENOXYBENZAMINE HYDROCHLORIDE10MGCAPSULE / ORALAB2020-10-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A212568-001AB1a50c72e98297…

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. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

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
application applno (ANDA): 212568
application number: ANDA212568

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