cardura xl

Generic: doxazosin mesylate

Labeler: viatris specialty llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name cardura xl
Generic Name doxazosin mesylate
Labeler viatris specialty llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

doxazosin mesylate 8 mg/1

Manufacturer
Viatris Specialty LLC

Identifiers & Regulatory

Product NDC 58151-079
Product ID 58151-079_7fe31b0a-4fb2-427f-83e2-d5b957d6738b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021269
Listing Expiration 2026-12-31
Marketing Start 2024-01-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58151079
Hyphenated Format 58151-079

Supplemental Identifiers

RxCUI
636360 636361 1242404 1242408
UPC
0358151078936
UNII
86P6PQK0MU

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 cardura xl (source: ndc)
Generic Name doxazosin mesylate (source: ndc)
Application Number NDA021269 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58151-079-93)
source: ndc

Packages (1)

58151-079-93 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58151-079-93)

Ingredients (1)

doxazosin mesylate (8 mg/1)

Linked Drug Pages (1)

Cardura XL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7fe31b0a-4fb2-427f-83e2-d5b957d6738b", "openfda": {"upc": ["0358151078936"], "unii": ["86P6PQK0MU"], "rxcui": ["636360", "636361", "1242404", "1242408"], "spl_set_id": ["355bcdce-0481-48ba-8ebd-2009106aaf77"], "manufacturer_name": ["Viatris Specialty LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58151-079-93)", "package_ndc": "58151-079-93", "marketing_start_date": "20240104"}], "brand_name": "Cardura XL", "product_id": "58151-079_7fe31b0a-4fb2-427f-83e2-d5b957d6738b", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Antagonists [MoA]", "alpha-Adrenergic Blocker [EPC]"], "product_ndc": "58151-079", "generic_name": "doxazosin mesylate", "labeler_name": "Viatris Specialty LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cardura", "brand_name_suffix": "XL", "active_ingredients": [{"name": "DOXAZOSIN MESYLATE", "strength": "8 mg/1"}], "application_number": "NDA021269", "marketing_category": "NDA", "marketing_start_date": "20240104", "listing_expiration_date": "20261231"}