Durlaza
NDC Package 58487-001-01

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 inactivated by the FDA.

Durlaza is indicated to:Reduce the risk of death and myocardial infarction (MI) in patients with chronic coronary artery disease, such as patients with a history of MI or unstable angina pectoris or with chronic stable anginaReduce the risk of death and recurrent stroke in patients who have had an ischemic stroke or transient ischemic attackLimitation of Use: Use immediate-release aspirin, not DURLAZA in situations where a rapid onset of action is required (such as acute treatment of myocardial infarction or before percutaneous coronary intervention). Marketed by New Haven Pharmaceuticals, Inc., this product is identified by NDC 58487-001 and is authorized under FDA application NDA200671.

Identification & Billing

NDC Package Code
58487-001-01
Package Description
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code
58487-001
11-Digit Billing Format
58487000101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Durlaza
Dosage Form
-
Usage Information
DURLAZA is indicated to:Reduce the risk of death and myocardial infarction (MI) in patients with chronic coronary artery disease, such as patients with a history of MI or unstable angina pectoris or with chronic stable anginaReduce the risk of death and recurrent stroke in patients who have had an ischemic stroke or transient ischemic attackLimitation of Use: Use immediate-release aspirin, not DURLAZA in situations where a rapid onset of action is required (such as acute treatment of myocardial infarction or before percutaneous coronary intervention).

Regulatory & Marketing

Labeler Name
New Haven Pharmaceuticals, Inc.
FDA Application #
NDA200671
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-25-2015
Listing Expiration
12-31-2017
Exclude Flag
I
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 (58487-001). Click a package code to view its specific billing and regulatory data.

58487-001-02
90 CAPSULE, EXTENDED RELEASE 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 58487-001-01 identifies a specific commercial package of 30 capsule, extended release in 1 bottle of Durlaza, labeled by New Haven Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. 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 New Haven Pharmaceuticals, Inc. on September 25, 2015. The current certification is valid through December 31, 2017.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58487000101. 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)
58487-001-01
11-Digit CMS (5-4-2)
58487-0001-01

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