phenoxybenzamine hydrochloride

Generic: phenoxybenzamine hydrochloride

Labeler: burel pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phenoxybenzamine hydrochloride
Generic Name phenoxybenzamine hydrochloride
Labeler burel pharmaceuticals, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

phenoxybenzamine hydrochloride 10 mg/1

Manufacturer
Burel Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 35573-473
Product ID 35573-473_609aa41e-4cb5-4cdf-9137-f429c21b4fab
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215600
Listing Expiration 2026-12-31
Marketing Start 2023-05-08

Pharmacologic Class

Classes
adrenergic alpha-antagonists [moa] alpha-adrenergic blocker [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 35573473
Hyphenated Format 35573-473

Supplemental Identifiers

RxCUI
861402
UNII
X1IEG24OHL

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name phenoxybenzamine hydrochloride (source: ndc)
Generic Name phenoxybenzamine hydrochloride (source: ndc)
Application Number ANDA215600 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (35573-473-02)
source: ndc

Packages (1)

35573-473-02 100 CAPSULE in 1 BOTTLE (35573-473-02)

Ingredients (1)

phenoxybenzamine hydrochloride (10 mg/1)

Linked Drug Pages (1)

PHENOXYBENZAMINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "609aa41e-4cb5-4cdf-9137-f429c21b4fab", "openfda": {"unii": ["X1IEG24OHL"], "rxcui": ["861402"], "spl_set_id": ["609aa41e-4cb5-4cdf-9137-f429c21b4fab"], "manufacturer_name": ["Burel Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (35573-473-02)", "package_ndc": "35573-473-02", "marketing_start_date": "20230508"}], "brand_name": "PHENOXYBENZAMINE HYDROCHLORIDE", "product_id": "35573-473_609aa41e-4cb5-4cdf-9137-f429c21b4fab", "dosage_form": "CAPSULE", "pharm_class": ["Adrenergic alpha-Antagonists [MoA]", "alpha-Adrenergic Blocker [EPC]"], "product_ndc": "35573-473", "generic_name": "PHENOXYBENZAMINE HYDROCHLORIDE", "labeler_name": "Burel Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PHENOXYBENZAMINE HYDROCHLORIDE", "active_ingredients": [{"name": "PHENOXYBENZAMINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA215600", "marketing_category": "ANDA", "marketing_start_date": "20230508", "listing_expiration_date": "20261231"}