NDC Package 59310-540-20 Proair Digihaler

Albuterol Sulfate Powder, Metered Respiratory (inhalation) - View Billable Units, 11-Digit Format, RxNorm

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Package Information

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:

59310-540-20

Package Description:

1 INHALER in 1 BOX / 200 POWDER, METERED in 1 INHALER

Product Code:

59310-540

Proprietary Name:

Proair Digihaler

Non-Proprietary Name:

Albuterol Sulfate

Substance Name:

Albuterol Sulfate

Usage Information:

Albuterol (also known as salbutamol) is used to treat wheezing and shortness of breath caused by breathing problems such as asthma. It is a quick-relief medication. Albuterol belongs to a class of drugs known as bronchodilators. It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. Controlling symptoms of breathing problems can decrease time lost from work or school.

11-Digit NDC Billing Format:

59310054020

NDC to RxNorm Crosswalk:

RxCUI: 2166796 - albuterol 90 MCG /INHAL Dry Powder Inhaler with sensor, 200 Actuations
RxCUI: 2166796 - Sensor 200 ACTUAT albuterol 0.09 MG/ACTUAT Dry Powder Inhaler
RxCUI: 2166797 - ProAir digihaler 90 MCG /INHAL Dry Powder Inhaler, 200 Actuations
RxCUI: 2166797 - Sensor 200 ACTUAT albuterol 0.09 MG/ACTUAT Dry Powder Inhaler [ProAir]
RxCUI: 2166797 - Sensor 200 ACTUAT ProAir 0.09 MG/ACTUAT Dry Powder Inhaler

Product Type:

Human Prescription Drug

Labeler Name:

Teva Respiratory, Llc

Dosage Form:

Powder, Metered - An powder dosage form that is situated inside a container that has a mechanism to deliver a specified quantity.

Administration Route(s):

Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.

Active Ingredient(s):

ALBUTEROL SULFATE 90 ug/1

Pharmacologic Class(es):

Sample Package:

Yes

FDA Application Number:

NDA205636

Marketing Category:

NDA - A product marketed under an approved New Drug Application.

Start Marketing Date:

10-04-2019

End Marketing Date:

02-28-2026

Exclude Flag:

Code Structure:

59310 - Teva Respiratory, Llc
- 59310-540 - Proair Digihaler
  - 59310-540-20 - 1 INHALER in 1 BOX / 200 POWDER, METERED in 1 INHALER

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 Code	Package Description
59310-540-21	1 INHALER in 1 BOX / 200 POWDER, METERED in 1 INHALER

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 59310-540-20?

The NDC Packaged Code 59310-540-20 is assigned to a package of 1 inhaler in 1 box / 200 powder, metered in 1 inhaler of Proair Digihaler, a human prescription drug labeled by Teva Respiratory, Llc. The product's dosage form is powder, metered and is administered via respiratory (inhalation) form.

Is NDC 59310-540 included in the NDC Directory?

Yes, Proair Digihaler with product code 59310-540 is active and included in the NDC Directory. The product was first marketed by Teva Respiratory, Llc on October 04, 2019.

What is the 11-digit format for NDC 59310-540-20?

The 11-digit format is 59310054020. 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 5-3-2 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	59310-540-20	5-4-2	59310-0540-20

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