alfuzosin hydrochloride

Generic: alfuzosin hydrochloride

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name alfuzosin hydrochloride
Generic Name alfuzosin hydrochloride
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

alfuzosin hydrochloride 10 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 43353-945
Product ID 43353-945_15c875e9-bc9e-4d06-83f5-0cc5c6742302
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 43353945
Hyphenated Format 43353-945

Supplemental Identifiers

RxCUI
861132
UNII
75046A1XTN

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
  • 6000 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-945-16)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-945-30)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-945-60)
source: ndc

Packages (3)

43353-945-16 6000 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-945-16) 43353-945-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-945-30) 43353-945-60 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-945-60)

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": "15c875e9-bc9e-4d06-83f5-0cc5c6742302", "openfda": {"unii": ["75046A1XTN"], "rxcui": ["861132"], "spl_set_id": ["790fe381-4a83-402e-b6c0-2ecde9cac7a7"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "6000 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-945-16)", "package_ndc": "43353-945-16", "marketing_start_date": "20140522"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-945-30)", "package_ndc": "43353-945-30", "marketing_start_date": "20150402"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-945-60)", "package_ndc": "43353-945-60", "marketing_start_date": "20150402"}], "brand_name": "Alfuzosin hydrochloride", "product_id": "43353-945_15c875e9-bc9e-4d06-83f5-0cc5c6742302", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Antagonists [MoA]", "alpha-Adrenergic Blocker [EPC]"], "product_ndc": "43353-945", "generic_name": "Alfuzosin hydrochloride", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "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"}