Proair Digihaler
NDC Package 59310-540-20

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.

Proair Digihaler is use of ProAir Digihaler is contraindicated in patients with a history of hypersensitivity to albuterol and/or severe hypersensitivity to milk proteins. Marketed by Teva Respiratory, Llc, this product is identified by NDC 59310-540 and is authorized under FDA application NDA205636.

Identification & Billing

NDC Package Code
59310-540-20
Package Description
1 INHALER in 1 BOX / 200 POWDER, METERED in 1 INHALER
Product Code
59310-540
11-Digit Billing Format
59310054020
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

Clinical Specifications

Proprietary Name
Proair Digihaler
Dosage Form
-
Usage Information
Use of ProAir Digihaler is contraindicated in patients with a history of hypersensitivity to albuterol and/or severe hypersensitivity to milk proteins. Rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate. There have been reports of anaphylactic reactions in patients using inhalation therapies containing lactose [see Warnings and Precautions (5.6)].

Regulatory & Marketing

Labeler Name
Teva Respiratory, Llc
FDA Application #
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
Listing Expiration
02-28-2026
Exclude Flag
D
Sample Package
Yes

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 (59310-540). Click a package code to view its specific billing and regulatory data.

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

* 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 59310-540-20 identifies a specific commercial package of 1 inhaler in 1 box / 200 powder, metered in 1 inhaler of Proair Digihaler, labeled by Teva Respiratory, Llc. 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 Teva Respiratory, Llc on October 04, 2019. The current certification is valid through February 28, 2026.

How is this Teva Respiratory, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59310054020. 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)
59310-540-20
11-Digit CMS (5-4-2)
59310-0540-20

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