Cardura Tablet, Film Coated, Extended Release
NDC Package 58151-079-93
Package Information
Cardura (doxazosin mesylate) tablets is doxazosin is used alone or with other drugs to treat high blood pressure (hypertension). This formulation utilizes a tablet, film coated, extended release delivery system. Marketed by Viatris Specialty Llc, this product is identified by NDC 58151-079 and is authorized under FDA application NDA021269.
Identification & Billing
- RxCUI: 1242404 - Cardura XL 4 MG 24HR Extended Release Oral Tablet
- RxCUI: 1242404 - 24 HR doxazosin 4 MG Extended Release Oral Tablet [Cardura]
- RxCUI: 1242404 - 24 HR Cardura 4 MG Extended Release Oral Tablet
- RxCUI: 1242404 - Cardura XL 4 MG (as doxazosin mesylate 5.1 MG) 24 HR Extended Release Oral Tablet
- RxCUI: 1242404 - Cardura XL 4 MG 24 HR Extended Release Oral Tablet
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 58151 - Viatris Specialty Llc
- 58151-079 - Cardura
- 58151-079-93 - 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
- 58151-079 - Cardura
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.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 58151-079-93 identifies a specific commercial package of 30 tablet, film coated, extended release in 1 bottle of Cardura XL, a human prescription drug labeled by Viatris Specialty Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This tablet, film coated, extended release is formulated for oral 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 Specialty Llc on January 04, 2024. 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 Specialty Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 58151007993. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.