Edarbyclor
NDC Package 64764-944-07

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.

Edarbyclor is a medication used to treat high blood pressure (hypertension). Marketed by Takeda Pharmaceuticals America, Inc., this product is identified by NDC 64764-944 and is authorized under FDA application NDA202331.

Identification & Billing

NDC Package Code
64764-944-07
Package Description
5 CARTON in 1 TRAY / 1 BLISTER PACK in 1 CARTON / 7 TABLET in 1 BLISTER PACK
Product Code
64764-944
11-Digit Billing Format
64764094407

Clinical Specifications

Proprietary Name
Edarbyclor
Dosage Form
-
Usage Information
This medication is used to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This product contains two medications: azilsartan and chlorthalidone. Azilsartan works by relaxing blood vessels so blood can flow more easily. It belongs to a class of drugs called angiotensin receptor blockers (ARBs). Chlorthalidone causes your body to get rid of extra salt and water by making more urine. It is called a "water pill" or diuretic.

Regulatory & Marketing

Labeler Name
Takeda Pharmaceuticals America, Inc.
FDA Application #
NDA202331
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-23-2011
End Marketing Date
05-01-2018
Listing Expiration
05-01-2018
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 (64764-944). Click a package code to view its specific billing and regulatory data.

64764-944-30
30 TABLET in 1 BOTTLE
64764-944-90
90 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 64764-944-07 identifies a specific commercial package of 5 carton in 1 tray / 1 blister pack in 1 carton / 7 tablet in 1 blister pack of Edarbyclor, labeled by Takeda Pharmaceuticals America, 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 Takeda Pharmaceuticals America, Inc. on December 23, 2011. The current certification is valid through May 01, 2018.

What are the primary indications for this medication?

This medication is used to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This product contains two medications: azilsartan and chlorthalidone. Azilsartan works by relaxing blood vessels so blood can flow more easily. It belongs to a class of drugs called angiotensin receptor blockers (ARBs). Chlorthalidone causes your body to get rid of extra salt and water by making more urine. It is called a "water pill" or diuretic.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64764094407. 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)
64764-944-07
11-Digit CMS (5-4-2)
64764-0944-07

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