Edarbyclor Tablet
NDC Package 60631-412-30

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

Package Information

Edarbyclor (azilsartan kamedoxomil and chlorthalidone) tablets is a medication used to treat high blood pressure (hypertension). This formulation utilizes a tablet delivery system. Marketed by Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals), this product is identified by NDC 60631-412 and is authorized under FDA application NDA202331.

Identification & Billing

NDC Package Code
60631-412-30
Package Description
30 TABLET in 1 BOTTLE
Product Code
60631-412
11-Digit Billing Format
60631041230
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk
  • RxCUI: 1235144 - azilsartan medoxomil 40 MG / chlorthalidone 12.5 MG Oral Tablet
  • RxCUI: 1235150 - edarbyclor 40 MG / 12.5 MG Oral Tablet
  • RxCUI: 1235150 - azilsartan medoxomil 40 MG / chlorthalidone 12.5 MG Oral Tablet [Edarbyclor]
  • RxCUI: 1235150 - Edarbyclor 40/12.5 (azilsartan medoxomil (azilsartan kamedoxomil 42.68 MG) / chlorthalidone) Oral Tablet
  • RxCUI: 1235150 - Edarbyclor 40/12.5 Oral Tablet

Clinical Specifications

Proprietary Name
Edarbyclor
Non-Proprietary Name
Azilsartan Kamedoxomil And Chlorthalidone
Substance Name
Azilsartan Kamedoxomil; Chlorthalidone
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
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
Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)
Product Type
Human Prescription Drug
FDA Application #
NDA202331
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-01-2013
Listing Expiration
12-31-2026
Exclude Flag
N
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 60631-412-30 identifies a specific commercial package of 30 tablet in 1 bottle of Edarbyclor, a human prescription drug labeled by Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals). This tablet is formulated for oral use and contains azilsartan kamedoxomil; chlorthalidone 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 Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) on February 01, 2013. The current certification is valid through December 31, 2026.

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 Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60631041230. 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:

10-Digit Format (5-3-2)
60631-412-30
11-Digit CMS (5-4-2)
60631-0412-30

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