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  5. NDC Package Code: 0078-0664-19 Utibron Neohaler

NDC Package 0078-0664-19 Utibron Neohaler

View Billable Units, 11-Digit Format, RxNorm

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.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0078-0664-19
Package Description:
60 BLISTER PACK in 1 BOX, UNIT-DOSE / 1 CAPSULE in 1 BLISTER PACK (0078-0664-61)
Product Code:
0078-0664
Proprietary Name:
Utibron Neohaler
Usage Information:
This product is used to control and prevent symptoms (such as wheezing and shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema). Controlling symptoms of breathing problems helps you stay active. This inhaler contains 2 medications: indacaterol and glycopyrrolate. Both drugs work by relaxing the muscles around the airways so that they open up and you can breathe more easily. Indacaterol belongs to the class of drugs known as long-acting beta agonists (LABAs). Glycopyrrolate belongs to a class of drugs known as anticholinergics. Both drugs are also known as bronchodilators. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden shortness of breath. If sudden breathing problems occur, use your quick-relief inhaler as prescribed. Indacaterol/glycopyrrolate is not approved to treat asthma. People with asthma using long-acting inhaled beta agonists (such as indacaterol) without also using an inhaled corticosteroid may have an increased risk of serious (sometimes fatal) breathing problems.
11-Digit NDC Billing Format:
00078066419
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
60 EA
Labeler Name:
Novartis Pharmaceuticals Corporation
Sample Package:
No
FDA Application Number:
NDA207930
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
10-29-2015
End Marketing Date:
06-30-2019
Listing Expiration Date:
06-30-2019
Exclude Flag:
D
Code Structure:

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
0078-0664-066 CAPSULE in 1 BOX, UNIT-DOSE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 0078-0664-19?

The NDC Packaged Code 0078-0664-19 is assigned to a package of 60 blister pack in 1 box, unit-dose / 1 capsule in 1 blister pack (0078-0664-61) of Utibron Neohaler, labeled by Novartis Pharmaceuticals Corporation. The product's dosage form is and is administered via form.

Is NDC 0078-0664 included in the NDC Directory?

No, Utibron Neohaler with product code 0078-0664 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Novartis Pharmaceuticals Corporation on October 29, 2015 and its listing in the NDC Directory is set to expire on June 30, 2019 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0078-0664-19?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 60.

What is the 11-digit format for NDC 0078-0664-19?

The 11-digit format is 00078066419. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
4-4-20078-0664-195-4-200078-0664-19