uroxatral

Generic: alfuzosin hcl

Labeler: advanz pharma (us) corp.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name uroxatral
Generic Name alfuzosin hcl
Labeler advanz pharma (us) corp.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

alfuzosin hydrochloride 10 mg/1

Manufacturer
Advanz Pharma (US) Corp.

Identifiers & Regulatory

Product NDC 59212-200
Product ID 59212-200_ffbc758d-7556-4269-8947-baa7ddb88541
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021287
Listing Expiration 2026-12-31
Marketing Start 2013-06-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59212200
Hyphenated Format 59212-200

Supplemental Identifiers

RxCUI
861132 861134
UNII
75046A1XTN

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 uroxatral (source: ndc)
Generic Name alfuzosin hcl (source: ndc)
Application Number NDA021287 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59212-200-10)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (59212-200-30)
source: ndc

Packages (2)

59212-200-10 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59212-200-10) 59212-200-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (59212-200-30)

Ingredients (1)

alfuzosin hydrochloride (10 mg/1)

Linked Drug Pages (1)

Uroxatral ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ffbc758d-7556-4269-8947-baa7ddb88541", "openfda": {"unii": ["75046A1XTN"], "rxcui": ["861132", "861134"], "spl_set_id": ["9fc7f119-f36b-44cf-945d-940160f3afe3"], "manufacturer_name": ["Advanz Pharma (US) Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59212-200-10)", "package_ndc": "59212-200-10", "marketing_start_date": "20130603"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (59212-200-30)", "package_ndc": "59212-200-30", "marketing_start_date": "20190118"}], "brand_name": "Uroxatral", "product_id": "59212-200_ffbc758d-7556-4269-8947-baa7ddb88541", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Antagonists [MoA]", "alpha-Adrenergic Blocker [EPC]"], "product_ndc": "59212-200", "generic_name": "Alfuzosin HCl", "labeler_name": "Advanz Pharma (US) Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Uroxatral", "active_ingredients": [{"name": "ALFUZOSIN HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "NDA021287", "marketing_category": "NDA", "marketing_start_date": "20130603", "listing_expiration_date": "20261231"}