Quick answers
- What is Doxazosin used for?
- The FDA-approved label (Cardura, Viatris Specialty LLC, October 15, 2023) says: “CARDURA is an alpha 1 adrenergic antagonist indicated for: • Signs and symptoms of Benign Prostatic Hyperplasia (BPH) • Treatment of Hypertension 1.1 Benign Prostatic Hyperplasia (BPH) CARDURA is indicated for the treatment of the signs and symptoms of BPH. 1.2 Hypertension CARDURA is indicated for the treatment of hypertension, to lower blood pressure. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Doxazosin have a boxed warning?
- No. None of the 64 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Doxazosin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Doxazosin been recalled?
- FDA enforcement reports list 8 recalls of products of this medicine; the newest started January 21, 2026 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Doxazosin?
- 31 companies list prescription products of Doxazosin in the FDA NDC Directory, including A-S Medication Solutions, Aphena Pharma Solutions - Tennessee, LLC and Bryant Ranch Prepack.
What Doxazosin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
CARDURA is an alpha 1 adrenergic antagonist indicated for: • Signs and symptoms of Benign Prostatic Hyperplasia (BPH) • Treatment of Hypertension 1.1 Benign Prostatic Hyperplasia (BPH) CARDURA is indicated for the treatment of the signs and symptoms of BPH. 1.2 Hypertension CARDURA is indicated for the treatment of hypertension, to lower blood pressure. …
— FDA label: Cardura, Viatris Specialty LLC, effective October 15, 2023. Read the full label on DailyMed →
The FDA has 64 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 64 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Tablet, film coated, extended release |
|---|---|
| Route | Oral |
| Prescription products | 130 in the FDA NDC Directory |
| Brand names | Cardura, Cardura XL |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| doxazosin mesylate 1 mg tablet | Generic | $0.0663 per tablet |
| doxazosin mesylate 2 mg tablet | Generic | $0.0580 per tablet |
| doxazosin mesylate 4 mg tablet | Generic | $0.0802 per tablet |
| doxazosin mesylate 4 mg tablet, film coated, extended release | Brand: Cardura XL | $6.99 per tablet |
| doxazosin mesylate 8 mg tablet | Generic | $0.0944 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- A-S Medication Solutions12 products
- Aphena Pharma Solutions - Tennessee, LLC10 products
- Bryant Ranch Prepack9 products
- NuCare Pharmaceuticals, Inc.7 products
- Mylan Pharmaceuticals Inc.7 products
- Viatris Specialty LLC6 products
- Teva Pharmaceuticals USA, Inc.4 products
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.4 products
- Zydus Pharmaceuticals USA Inc.4 products
- Golden State Medical Supply, Inc.4 products
- Upsher-Smith Laboratories, LLC4 products
- Rising Pharma Holdings, Inc.4 products
- Aurobindo Pharma Limited4 products
- Remedyrepack Inc.4 products
- Accord Healthcare Inc.4 products
- Zydus Lifesciences Limited4 products
- Unichem Pharmaceuticals (USA), Inc.4 products
- AvPAK4 products
- Apotex Corp.4 products
- Chartwell RX, LLC4 products
- American Health Packaging3 products
- Major Pharmaceuticals3 products
- AvKARE3 products
- Northwind Health Company, LLC3 products
- Roerig3 products
- Preferred Pharmaceuticals Inc.2 products
- Proficient Rx LP2 products
- PD-Rx Pharmaceuticals, Inc.1 product
- Unichem Laboratories Limited, India1 product
- Cardinal Health 107, LLC1 product
- Direct_Rx1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA019668 CARDURA | Viatris | November 2, 1990 | 23, latest June 23, 2021 2021: Labeling · 2016: Labeling · 2014: Manufacturing (CMC) |
| NDA021269 CARDURA XL | Viatris | February 22, 2005 | 8, latest June 22, 2021 2021: Labeling · 2017: Labeling · 2015: Labeling |
Generic approvals (10)
- ANDA075536Teva · October 18, 2000
- ANDA075580Apotex · October 18, 2000
- ANDA075646Chartwell Rx · October 18, 2000
- ANDA075509Aurobindo Pharma USA · October 19, 2000
- ANDA202824Accord Hlthcare · June 11, 2014
- ANDA208719Zydus Pharms · July 7, 2017
- ANDA205210Heritage Pharma · February 13, 2018
- ANDA209013Somerset Theraps LLC · April 17, 2018
- ANDA212727Rising · March 15, 2022
- ANDA212329Unichem · January 10, 2024
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
January 21, 2026 · Class III · Ongoing · D-0306-2026
Tablets/Capsules Imprinted with Wrong ID
Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Pharmaceuticals (USA), Inc., 1 Tower Center Boulevard, Suite 2200, East Brunswick, NJ 08816 USA, manufactured by Unichem Laboratories — Unichem Pharmaceuticals USA Inc.
-
December 23, 2024 · Class II · Terminated · D-0204-2025
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-078-93 — Viatris Inc
-
December 23, 2024 · Class II · Terminated · D-0203-2025
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-079-93 — Viatris Inc
-
March 16, 2023 · Class II · Ongoing · D-0550-2023
CGMP Deviations
Doxazosin Tablets, USP, 4mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-109-52 — Northwind Pharmaceuticals LLC
-
February 7, 2023 · Class II · Terminated · D-0387-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Doxazosin Tablets USP, 2 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-414-01 UPC 3 16729 41401 2; b) 1,000-count NDC 16729-414-17 UPC 3 16729 41417 3; Manufactured for: Accord Healthcare, Inc., Durham, NC 2770 — Accord Healthcare, Inc.
-
February 7, 2023 · Class II · Terminated · D-0386-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Doxazosin Tablets USP 1 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-211-01 UPC 3 16729 21101 7; b) 1,000-count bottle NDC 16729-211-17 UPC 3 16729 21117 8; Manufactured for: Accord Healthcare, Inc., Durham, N — Accord Healthcare, Inc.
-
February 7, 2023 · Class II · Terminated · D-0389-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Doxazosin Tablets USP, 8 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-415-01 UPC 3 16729 41501 9; b) 1,000 Tablets NDC 16729-415-17 UPC 3 16729 41517 0; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. — Accord Healthcare, Inc.
-
February 7, 2023 · Class II · Terminated · D-0388-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Doxazosin Tablets USP, 4 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-213-01 UPC 3 16729 21301 1; b) 1,000-count bottle NDC 16729-213-17 UPC 3 16729 21317 2; Manufactured for: Accord Healthcare, Inc., Durham, — Accord Healthcare, Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Cardura, Viatris Specialty LLC, effective October 15, 2023; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →