cardura

Generic: doxazosin

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

Drug Facts

Product Profile

Brand Name cardura
Generic Name doxazosin
Labeler viatris specialty llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

doxazosin mesylate 8 mg/1

Manufacturer
Viatris Specialty LLC

Identifiers & Regulatory

Product NDC 58151-077
Product ID 58151-077_438349cb-eae0-43b5-b045-d447b1c9a376
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019668
Listing Expiration 2027-12-31
Marketing Start 2025-04-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58151077
Hyphenated Format 58151-077

Supplemental Identifiers

RxCUI
104367 104368 104369 197625 197626 197627 197628 205544
UPC
0358151074013
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 (source: ndc)
Generic Name doxazosin (source: ndc)
Application Number NDA019668 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING CARDURA (doxazosin) is available as tablets for oral administration. Each tablet contains doxazosin mesylate equivalent to 1 mg (white), 2 mg (white), 4 mg (white) or 8 mg (white) of doxazosin as the free base. NDC and Pack Size Strength Description NDC 58151-074-01 (Bottle of 100) 1 mg White, round tablets with “CN1” on one side and “VLE” on the other side. NDC 58151-075-01 (Bottle of 100) 2 mg White, oblong tablets with score and “CN 2” on one side and “VLE” on the other side. NDC 58151-076-01 (Bottle of 100) 4 mg White, rhombus shaped tablets with break score and “CN 4” on one side and VLE on the other side. NDC 58151-077-01 (Bottle of 100) 8 mg White, capsule shaped tablets with break score and “CN 8” on one side and “VLE” on the other side. Recommended Storage: Store at 25°C (77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
  • PRINCIPAL DISPLAY PANEL – 1 mg NDC 58151-074-01 Cardura ® (doxazosin) tablets 1 mg* 100 Tablets Rx only Store at 25°C (77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Recommended Dosage See prescribing information. *Each tablet contains doxazosin mesylate equivalent to 1 mg doxazosin as a free base. Made in Germany Distributed by: Viatris Specialty LLC Morgantown, WV 26505 U.S.A. © 2023 Viatris Inc. RUPJ074A Cardura (doxazosin) Tablets 1 mg Bottle Label
  • PRINCIPAL DISPLAY PANEL – 2 mg NDC 58151-075-01 Cardura ® (doxazosin) tablets 2 mg* 100 Tablets Rx only Store at 25°C (77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Recommended Dosage See prescribing information. *Each tablet contains doxazosin mesylate equivalent to 2 mg doxazosin as a free base. Made in Germany Distributed by: Viatris Specialty LLC Morgantown, WV 26505 U.S.A. © 2023 Viatris Inc. RUPJ075A Cardura (doxazosin) Tablets 2 mg Bottle Label
  • PRINCIPAL DISPLAY PANEL – 4 mg NDC 58151-076-01 Cardura ® (doxazosin) tablets 4 mg* 100 Tablets Rx only Store at 25°C (77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Recommended Dosage See prescribing information. *Each tablet contains doxazosin mesylate equivalent to 4 mg doxazosin as a free base. Made in Germany Distributed by: Viatris Specialty LLC Morgantown, WV 26505 U.S.A. © 2023 Viatris Inc. RUPJ076A Cardura (doxazosin) Tablets 4 mg Bottle Label
  • PRINCIPAL DISPLAY PANEL – 8 mg NDC 58151-077-01 Cardura® (doxazosin) tablets 8 mg* 100 Tablets Rx only Store at 25°C (77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Recommended Dosage See prescribing information. *Each tablet contains doxazosin mesylate equivalent to 8 mg doxazosin as a free base. Made in Germany Distributed by: Viatris Specialty LLC Morgantown, WV 26505 U.S.A. © 2023 Viatris Inc. RUPJ077A Cardura (doxazosin) Tablets 8 mg Bottle Label
source: label

Packages (0)

No package records.

Ingredients (1)

doxazosin mesylate (8 mg/1)

Linked Drug Pages (1)

Cardura ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "438349cb-eae0-43b5-b045-d447b1c9a376", "openfda": {"upc": ["0358151074013"], "unii": ["86P6PQK0MU"], "rxcui": ["104367", "104368", "104369", "197625", "197626", "197627", "197628", "205544"], "spl_set_id": ["5e1f5e49-2da1-43ab-9795-228a8bcc5a82"], "manufacturer_name": ["Viatris Specialty LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Cardura", "product_id": "58151-077_438349cb-eae0-43b5-b045-d447b1c9a376", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha-Antagonists [MoA]", "alpha-Adrenergic Blocker [EPC]"], "product_ndc": "58151-077", "generic_name": "doxazosin", "labeler_name": "Viatris Specialty LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cardura", "active_ingredients": [{"name": "DOXAZOSIN MESYLATE", "strength": "8 mg/1"}], "application_number": "NDA019668", "marketing_category": "NDA", "marketing_start_date": "20250423", "listing_expiration_date": "20271231"}