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

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 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