Aridol Bronchial Challenge Test Kit
NDC Package 67850-552-01

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

Package Information

Aridol Bronchial Challenge Test Kit (mannitol) kits is mannitol, the active ingredient in ARIDOL, is a sugar alcohol indicated for the assessment of bronchial hyperresponsiveness in patients 6 years of age or older who do not have clinically apparent asthma.Limitations of Use:ARIDOL is not a standalone test or a screening test for asthma. This formulation utilizes a kit delivery system. Marketed by Methapharm, Inc., this product is identified by NDC 67850-552 and is authorized under FDA application NDA022368.

Identification & Billing

NDC Package Code
67850-552-01
Package Description
1 KIT in 1 KIT * 1 POWDER in 1 KIT * 1 POWDER in 1 KIT * 1 POWDER in 1 CAPSULE * 1 POWDER in 1 KIT
Product Code
67850-552
11-Digit Billing Format
67850055201
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.

Clinical Specifications

Proprietary Name
Aridol Bronchial Challenge Test Kit
Non-Proprietary Name
Mannitol
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Mannitol, the active ingredient in ARIDOL, is a sugar alcohol indicated for the assessment of bronchial hyperresponsiveness in patients 6 years of age or older who do not have clinically apparent asthma.Limitations of Use:ARIDOL is not a standalone test or a screening test for asthma. Bronchial challenge testing with ARIDOL should be used only as part of a physician's overall assessment of asthma.

Regulatory & Marketing

Labeler Name
Methapharm, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA022368
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-05-2010
End Marketing Date
05-31-2027
Exclude Flag
N
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 67850-552-01 identifies a specific commercial package of 1 kit in 1 kit * 1 powder in 1 kit * 1 powder in 1 kit * 1 powder in 1 capsule * 1 powder in 1 kit of Aridol Bronchial Challenge Test Kit, a human prescription drug labeled by Methapharm, Inc.. This kit is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Methapharm, Inc. on October 05, 2010.

How is this Methapharm, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67850055201. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
67850-552-01
11-Digit CMS (5-4-2)
67850-0552-01

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