alfuzosin hydrochloride extended release

Generic: alfuzosin hydrochloride

Labeler: cipla usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name alfuzosin hydrochloride extended release
Generic Name alfuzosin hydrochloride
Labeler cipla usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

alfuzosin hydrochloride 10 mg/1

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-844
Product ID 69097-844_497e0a60-9b09-4dcc-8cc6-1f13196f2db4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090284
Listing Expiration 2026-12-31
Marketing Start 2016-06-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69097844
Hyphenated Format 69097-844

Supplemental Identifiers

RxCUI
861132
UPC
0369097844073
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 extended release (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
  • 30 TABLET in 1 BOTTLE (69097-844-02)
  • 90 TABLET in 1 BOTTLE (69097-844-05)
  • 100 TABLET in 1 BOTTLE (69097-844-07)
  • 500 TABLET in 1 BOTTLE (69097-844-12)
source: ndc

Packages (4)

69097-844-02 30 TABLET in 1 BOTTLE (69097-844-02) 69097-844-05 90 TABLET in 1 BOTTLE (69097-844-05) 69097-844-07 100 TABLET in 1 BOTTLE (69097-844-07) 69097-844-12 500 TABLET in 1 BOTTLE (69097-844-12)

Ingredients (1)

alfuzosin hydrochloride (10 mg/1)

Linked Drug Pages (1)

Alfuzosin Hydrochloride extended release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "497e0a60-9b09-4dcc-8cc6-1f13196f2db4", "openfda": {"upc": ["0369097844073"], "unii": ["75046A1XTN"], "rxcui": ["861132"], "spl_set_id": ["3cc028d5-309f-4ce3-a2d7-5804ab57677d"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (69097-844-02)", "package_ndc": "69097-844-02", "marketing_start_date": "20160630"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (69097-844-05)", "package_ndc": "69097-844-05", "marketing_start_date": "20160630"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (69097-844-07)", "package_ndc": "69097-844-07", "marketing_start_date": "20160630"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (69097-844-12)", "package_ndc": "69097-844-12", "marketing_start_date": "20160630"}], "brand_name": "Alfuzosin Hydrochloride extended release", "product_id": "69097-844_497e0a60-9b09-4dcc-8cc6-1f13196f2db4", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha-Antagonists [MoA]", "alpha-Adrenergic Blocker [EPC]"], "product_ndc": "69097-844", "generic_name": "Alfuzosin Hydrochloride", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Alfuzosin Hydrochloride", "brand_name_suffix": "extended release", "active_ingredients": [{"name": "ALFUZOSIN HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA090284", "marketing_category": "ANDA", "marketing_start_date": "20160630", "listing_expiration_date": "20261231"}