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  5. NDC Package Code: 0078-0619-15 Arcapta Neohaler

NDC Package 0078-0619-15 Arcapta 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:
0078-0619-15
Package Description:
30 BLISTER PACK in 1 BOX, UNIT-DOSE / 1 CAPSULE in 1 BLISTER PACK (0078-0619-61)
Product Code:
0078-0619
Proprietary Name:
Arcapta Neohaler
Usage Information:
Indacaterol is used to treat trouble breathing and wheezing due to a certain ongoing lung disease (chronic obstructive pulmonary disease-COPD, including chronic bronchitis and/or emphysema). It is used if your breathing problems are not controlled with other medication (such as a quick-relief inhaler). Indacaterol belongs to the class of drugs known as long-acting beta agonists (LABAs). Indacaterol is also known as a bronchodilator. It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. This medication should not be used for severe/sudden breathing problems. Other medications, such as a quick-relief inhaler should be used instead of indacaterol for sudden breathing problems. This medication is not a substitute for corticosteroids (such as beclomethasone, fluticasone, prednisone). Indacaterol 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:
00078061915
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
30 EA
Labeler Name:
Novartis Pharmaceuticals Corporation
Sample Package:
No
FDA Application Number:
NDA022383
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
07-01-2011
End Marketing Date:
08-31-2018
Listing Expiration Date:
08-31-2018
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
0078-0619-066 CAPSULE in 1 BOX, UNIT-DOSE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 0078-0619-15?

The NDC Packaged Code 0078-0619-15 is assigned to a package of 30 blister pack in 1 box, unit-dose / 1 capsule in 1 blister pack (0078-0619-61) of Arcapta Neohaler, labeled by Novartis Pharmaceuticals Corporation. The product's dosage form is and is administered via form.

Is NDC 0078-0619 included in the NDC Directory?

No, Arcapta Neohaler with product code 0078-0619 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Novartis Pharmaceuticals Corporation on July 01, 2011 and its listing in the NDC Directory is set to expire on August 31, 2018 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0078-0619-15?

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 30.

What is the 11-digit format for NDC 0078-0619-15?

The 11-digit format is 00078061915. 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
4-4-20078-0619-155-4-200078-0619-15