Northera
NDC Package 76320-100-90

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.

Northera is droxidopa is used to treat symptoms of low blood pressure when standing, caused by a certain medical condition (neurogenic orthostatic hypotension-NOH). Marketed by Chelsea Therapeutics Inc, this product is identified by NDC 76320-100 and is authorized under FDA application NDA203202.

Identification & Billing

NDC Package Code
76320-100-90
Package Description
90 CAPSULE in 1 BOTTLE
Product Code
76320-100
11-Digit Billing Format
76320010090

Clinical Specifications

Proprietary Name
Northera
Dosage Form
-
Usage Information
Droxidopa is used to treat symptoms of low blood pressure when standing, caused by a certain medical condition (neurogenic orthostatic hypotension-NOH). This medication can lessen symptoms of low blood pressure when standing (orthostatic hypotension), such as dizziness, lightheadedness, or the "feeling that you are about to black out." Droxidopa is used by people whose daily activities are severely affected by this condition, even after other treatments are used (such as support stockings, water bolus). It is thought to work by making the blood vessels become more narrow, which increases blood pressure.

Regulatory & Marketing

Labeler Name
Chelsea Therapeutics Inc
FDA Application #
NDA203202
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-18-2014
End Marketing Date
08-31-2014
Listing Expiration
08-31-2014
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 (76320-100). Click a package code to view its specific billing and regulatory data.

76320-100-21
21 CAPSULE 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 76320-100-90 identifies a specific commercial package of 90 capsule in 1 bottle of Northera, labeled by Chelsea Therapeutics 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 Chelsea Therapeutics Inc on February 18, 2014. The current certification is valid through August 31, 2014.

What are the primary indications for this medication?

Droxidopa is used to treat symptoms of low blood pressure when standing, caused by a certain medical condition (neurogenic orthostatic hypotension-NOH). This medication can lessen symptoms of low blood pressure when standing (orthostatic hypotension), such as dizziness, lightheadedness, or the "feeling that you are about to black out." Droxidopa is used by people whose daily activities are severely affected by this condition, even after other treatments are used (such as support stockings, water bolus). It is thought to work by making the blood vessels become more narrow, which increases blood pressure.

How is this Chelsea Therapeutics Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76320010090. 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)
76320-100-90
11-Digit CMS (5-4-2)
76320-0100-90

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