alfuzosin hydrochloride

Generic: alfuzosin hydrochloride

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name alfuzosin hydrochloride
Generic Name alfuzosin hydrochloride
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

alfuzosin hydrochloride 10 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-249
Product ID 65862-249_d8c832c1-9455-4647-822a-ee4f35ba0560
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079060
Listing Expiration 2026-12-31
Marketing Start 2012-08-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862249
Hyphenated Format 65862-249

Supplemental Identifiers

RxCUI
861132
UPC
0365862249302
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 ANDA079060 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-249-01)
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-249-05)
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-249-30)
  • 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-249-90)
  • 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-249-99)
source: ndc

Packages (5)

65862-249-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-249-01) 65862-249-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-249-05) 65862-249-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-249-30) 65862-249-90 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-249-90) 65862-249-99 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-249-99)

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": "d8c832c1-9455-4647-822a-ee4f35ba0560", "openfda": {"upc": ["0365862249302"], "unii": ["75046A1XTN"], "rxcui": ["861132"], "spl_set_id": ["d163369b-e44b-4591-b166-7ddd0c1c13c0"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-249-01)", "package_ndc": "65862-249-01", "marketing_start_date": "20120830"}, {"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-249-05)", "package_ndc": "65862-249-05", "marketing_start_date": "20120830"}, {"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-249-30)", "package_ndc": "65862-249-30", "marketing_start_date": "20120830"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-249-90)", "package_ndc": "65862-249-90", "marketing_start_date": "20120830"}, {"sample": false, "description": "1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-249-99)", "package_ndc": "65862-249-99", "marketing_start_date": "20120830"}], "brand_name": "Alfuzosin Hydrochloride", "product_id": "65862-249_d8c832c1-9455-4647-822a-ee4f35ba0560", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Antagonists [MoA]", "alpha-Adrenergic Blocker [EPC]"], "product_ndc": "65862-249", "generic_name": "Alfuzosin Hydrochloride", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Alfuzosin Hydrochloride", "active_ingredients": [{"name": "ALFUZOSIN HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA079060", "marketing_category": "ANDA", "marketing_start_date": "20120830", "listing_expiration_date": "20261231"}