PHENOXYBENZAMINE HYDROCHLORIDE

Product NDC
72603-229
11-digit product format
726030229
Labeler code
72603
Product ID
72603-229_26f154d8-7509-4ed1-b9f4-4359987af757
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENOXYBENZAMINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA215600
Marketing category
ANDA
Marketing start
2024-10-01
Marketing end
2026-09-30
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

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
A215600-001PHENOXYBENZAMINE HYDROCHLORIDEPHENOXYBENZAMINE HYDROCHLORIDE10MGCAPSULE / ORALAB2023-05-08

Therapeutic equivalence codes#

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

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

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 22:54:322026-06A215600-001PHENOXYBENZAMINE HYDROCHLORIDE10MGCAPSULE / ORALAB2023-05-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A215600-001AB1a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHENOXYBENZAMINE HYDROCHLORIDEPHENOXYBENZAMINE HYDROCHLORIDENorthStar Rx LLC48a047c0-f409-420b-990a-2cab953a96cd2026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215600
application number: ANDA215600
ndc (product): 72603-229
PHENOXYBENZAMINE HYDROCHLORIDEPHENOXYBENZAMINE HYDROCHLORIDEBurel Pharmaceuticals, LLC609aa41e-4cb5-4cdf-9137-f429c21b4fab2024-08-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215600
application number: ANDA215600
PHENOXYBENZAMINE HYDROCHLORIDEPHENOXYBENZAMINE HYDROCHLORIDEAurobindo Pharma Limited75f26681-a079-4ff3-9fff-75526041374c2024-02-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215600
application number: ANDA215600

Additional Listing Data#

Finished product
Yes
Brand name base
PHENOXYBENZAMINE HYDROCHLORIDE

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENOXYBENZAMINE HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
X1IEG24OHLInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
861402Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
48a047c0-f409-420b-990a-2cab953a96cdAvailable on FDA.report

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
72603-229-01PHENOXYBENZAMINE HYDROCHLORIDE100 in 1 BOTTLECAPSULE1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-229-01EA - Each72603-229f0143b81-3e29-4a75-af39-bd1d05f8314c12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-229PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE [NORTHSTAR RX LLC]2Current NDC, 1 package rows20241001_48a047c0-f409-420b-990a-2cab953a96cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861402phenoxybenzamine HCl 10 MG Oral CapsulePSN48a047c0-f409-420b-990a-2cab953a96cd2
861402phenoxybenzamine hydrochloride 10 MG Oral CapsuleSCD48a047c0-f409-420b-990a-2cab953a96cd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72603-229-0172603022901100 CAPSULE in 1 BOTTLE (72603-229-01) 100 capsule2024-10-012026-09-30NoNoHistorical