Proairhfa
NDC Package 52959-978-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Proairhfa is pROAIR HFA Inhalation Aerosol is contraindicated in patients with a history of hypersensitivity to albuterol and any other PROAIR HFA Inhalation Aerosol components. Marketed by H.j. Harkins Company, Inc., this product is identified by NDC 52959-978 and is authorized under FDA application NDA021457.

Identification & Billing

NDC Package Code
52959-978-01
Package Description
200 AEROSOL, METERED in 1 INHALER
Product Code
52959-978
11-Digit Billing Format
52959097801
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
RxNorm Crosswalk
  • RxCUI: 2123072 - albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProAir
  • RxCUI: 2123072 - NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler
  • RxCUI: 2123072 - albuterol 90 MCG/ACTUAT Metered Dose Inhaler, 200 Actuations, generic for ProAir
  • RxCUI: 745752 - ProAir HFA 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations
  • RxCUI: 745752 - NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler [ProAir]

Clinical Specifications

Proprietary Name
Proairhfa Hfa
Dosage Form
-
Usage Information
PROAIR HFA Inhalation Aerosol is contraindicated in patients with a history of hypersensitivity to albuterol and any other PROAIR HFA Inhalation Aerosol components. Rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate [see Warnings and Precautions (5.6)].

Regulatory & Marketing

Labeler Name
H.j. Harkins Company, Inc.
FDA Application #
NDA021457
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-01-2004
Listing Expiration
12-31-2017
Exclude Flag
I
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 52959-978-01 identifies a specific commercial package of 200 aerosol, metered in 1 inhaler of Proairhfa Hfa, labeled by H.j. Harkins Company, 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 H.j. Harkins Company, Inc. on December 01, 2004. The current certification is valid through December 31, 2017.

How is this H.j. Harkins Company, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52959097801. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. 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)
52959-978-01
11-Digit CMS (5-4-2)
52959-0978-01

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