Metolazone
NDC Package 71406-113-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Metolazone is a "water pill" (diuretic) that increases the amount of urine you make, which causes your body to get rid of excess water. Marketed by Aace Pharmaceuticals, Inc., this product is identified by NDC 71406-113 and is authorized under FDA application ANDA216216.

Identification & Billing

NDC Package Code
71406-113-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
71406-113
11-Digit Billing Format
71406011301

Clinical Specifications

Proprietary Name
Metolazone
Dosage Form
-
Usage Information
Metolazone is a "water pill" (diuretic) that increases the amount of urine you make, which causes your body to get rid of excess water. This drug is used to treat high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This medication also reduces swelling/fluid retention (edema) which can result from conditions such as congestive heart failure or kidney disease. This can help to improve symptoms such as trouble breathing.

Regulatory & Marketing

Labeler Name
Aace Pharmaceuticals, Inc.
FDA Application #
ANDA216216
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-24-2021
End Marketing Date
10-06-2023
Listing Expiration
10-06-2023
Exclude Flag
D
Sample Package
No

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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (71406-113). Click a package code to view its specific billing and regulatory data.

71406-113-10
1000 TABLET in 1 BOTTLE

* 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 71406-113-01 identifies a specific commercial package of 100 tablet in 1 bottle of Metolazone, labeled by Aace Pharmaceuticals, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Aace Pharmaceuticals, Inc. on September 24, 2021. The current certification is valid through October 06, 2023.

What are the primary indications for this medication?

Metolazone is a "water pill" (diuretic) that increases the amount of urine you make, which causes your body to get rid of excess water. This drug is used to treat high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This medication also reduces swelling/fluid retention (edema) which can result from conditions such as congestive heart failure or kidney disease. This can help to improve symptoms such as trouble breathing.

How is this Aace Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71406011301. 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)
71406-113-01
11-Digit CMS (5-4-2)
71406-0113-01

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