Doxazosin Mesylate Tablet, Multilayer, Extended Release
NDC Package 65427-016-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Doxazosin Mesylate tablets is doxazosin is used alone or with other drugs to treat high blood pressure (hypertension). This formulation utilizes a tablet, multilayer, extended release delivery system. Marketed by Viatris Pharmaceuticals Llc, this product is identified by NDC 65427-016.

Identification & Billing

NDC Package Code
65427-016-01
Package Description
60000 TABLET, MULTILAYER, EXTENDED RELEASE in 1 DRUM
Product Code
65427-016
11-Digit Billing Format
65427001601

Clinical Specifications

Proprietary Name
Doxazosin Mesylate
Non-Proprietary Name
Doxazosin Mesylate
Substance Name
Doxazosin Mesylate
Dosage Form
Tablet, Multilayer, Extended Release - A solid dosage form containing medicinal substances that have been compressed to form a multiple-layered tablet or a tablet-within-a-tablet, the inner tablet being the core and the outer portion being the shell, which, additionally, is covered in a designated coating; the tablet is formulated in such manner as to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form.
Active Ingredient(s)
DOXAZOSIN MESYLATE 8 mg/1
Usage Information
Doxazosin is used alone or with other drugs to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This medication works by relaxing blood vessels so blood can flow more easily. Doxazosin is also used in men to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH). It does not shrink the prostate, but it works by relaxing the muscles in the prostate and part of the bladder. This helps to relieve symptoms of BPH such as difficulty in beginning the flow of urine, weak stream, and the need to urinate frequently or urgently (including during the middle of the night). Doxazosin belongs to a class of drugs known as alpha blockers.

Regulatory & Marketing

Labeler Name
Viatris Pharmaceuticals Llc
Product Type
Drug For Further Processing
Marketing Category
EXPORT ONLY - A product that is only exported and not marketed in the United States.
Start Marketing Date
07-03-2014
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 65427-016-01 identifies a specific commercial package of 60000 tablet, multilayer, extended release in 1 drum of Doxazosin Mesylate (UNFINISHED drug), drug for further processing labeled by Viatris Pharmaceuticals Llc. This tablet, multilayer, extended release is formulated for use and contains doxazosin mesylate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Viatris Pharmaceuticals Llc on July 03, 2014. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Doxazosin is used alone or with other drugs to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This medication works by relaxing blood vessels so blood can flow more easily. Doxazosin is also used in men to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH). It does not shrink the prostate, but it works by relaxing the muscles in the prostate and part of the bladder. This helps to relieve symptoms of BPH such as difficulty in beginning the flow of urine, weak stream, and the need to urinate frequently or urgently (including during the middle of the night). Doxazosin belongs to a class of drugs known as alpha blockers.

How is this Viatris Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65427001601. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
65427-016-01
11-Digit CMS (5-4-2)
65427-0016-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.