alfuzosin hydrochloride

Generic: alfuzosin hydrochloride

Labeler: exelan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name alfuzosin hydrochloride
Generic Name alfuzosin hydrochloride
Labeler exelan pharmaceuticals inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

alfuzosin hydrochloride 10 mg/1

Manufacturer
Exelan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 76282-302
Product ID 76282-302_663c0846-dc2c-409f-9fe0-bf2901ff92da
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090284
Listing Expiration 2026-12-31
Marketing Start 2012-10-02

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76282302
Hyphenated Format 76282-302

Supplemental Identifiers

RxCUI
861132
UPC
0376282302102 0376282302010 0376282302126
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 alfuzosin hydrochloride (source: ndc)
Generic Name alfuzosin hydrochloride (source: ndc)
Application Number ANDA090284 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (76282-302-01)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (76282-302-05)
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (76282-302-10)
  • 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (76282-302-12)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (76282-302-90)
source: ndc

Packages (5)

76282-302-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (76282-302-01) 76282-302-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (76282-302-05) 76282-302-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (76282-302-10) 76282-302-12 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (76282-302-12) 76282-302-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (76282-302-90)

Ingredients (1)

alfuzosin hydrochloride (10 mg/1)

Linked Drug Pages (1)

Alfuzosin hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "663c0846-dc2c-409f-9fe0-bf2901ff92da", "openfda": {"upc": ["0376282302102", "0376282302010", "0376282302126"], "unii": ["75046A1XTN"], "rxcui": ["861132"], "spl_set_id": ["f075a897-7bef-4799-b7e2-7e051c461443"], "manufacturer_name": ["Exelan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (76282-302-01)", "package_ndc": "76282-302-01", "marketing_start_date": "20121002"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (76282-302-05)", "package_ndc": "76282-302-05", "marketing_start_date": "20121002"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (76282-302-10)", "package_ndc": "76282-302-10", "marketing_start_date": "20121002"}, {"sample": false, "description": "120 TABLET, EXTENDED RELEASE in 1 BOTTLE (76282-302-12)", "package_ndc": "76282-302-12", "marketing_start_date": "20221201"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (76282-302-90)", "package_ndc": "76282-302-90", "marketing_start_date": "20190101"}], "brand_name": "Alfuzosin hydrochloride", "product_id": "76282-302_663c0846-dc2c-409f-9fe0-bf2901ff92da", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Antagonists [MoA]", "alpha-Adrenergic Blocker [EPC]"], "product_ndc": "76282-302", "generic_name": "Alfuzosin hydrochloride", "labeler_name": "Exelan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Alfuzosin hydrochloride", "active_ingredients": [{"name": "ALFUZOSIN HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA090284", "marketing_category": "ANDA", "marketing_start_date": "20121002", "listing_expiration_date": "20261231"}