Provocholine Inhalation Solution Kit
NDC Package 64281-110-06

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

Package Information

Provocholine Inhalation Solution (methacholine chloride inhalation solution) kits is provocholine is indicated for the diagnosis of bronchial airway hyperreactivity in subjects who do not have clinically apparent asthma. This formulation utilizes a kit delivery system. Marketed by Methapharm Inc., this product is identified by NDC 64281-110 and is authorized under FDA application NDA019193.

Identification & Billing

NDC Package Code
64281-110-06
Package Description
6 PACKAGE in 1 PACKAGE / 6 CARTON in 1 PACKAGE (64281-110-05) / 1 KIT in 1 CARTON * 1 VIAL, PLASTIC in 1 KIT / 3 mL in 1 VIAL, PLASTIC (64281-113-00) * 1 VIAL, PLASTIC in 1 KIT / 3 mL in 1 VIAL, PLASTIC (64281-115-00) * 1 VIAL, PLASTIC in 1 KIT / 3 mL in 1 VIAL, PLASTIC (64281-114-00) * 1 VIAL, PLASTIC in 1 KIT / 3 mL in 1 VIAL, PLASTIC (64281-116-00) * 1 VIAL, PLASTIC in 1 KIT / 3 mL in 1 VIAL, PLASTIC (64281-112-00) * 1 VIAL, PLASTIC in 1 KIT / 3 mL in 1 VIAL, PLASTIC (64281-111-00)
Product Code
64281-110
11-Digit Billing Format
64281011006
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Provocholine Inhalation Solution
Non-Proprietary Name
Methacholine Chloride Inhalation Solution
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Provocholine is indicated for the diagnosis of bronchial airway hyperreactivity in subjects who do not have clinically apparent asthma.

Regulatory & Marketing

Labeler Name
Methapharm Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA019193
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-03-2022
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage
  • 64281 - Methapharm Inc.
    • 64281-110 - Provocholine Inhalation Solution
      • 64281-110-06 - 6 PACKAGE in 1 PACKAGE / 6 CARTON in 1 PACKAGE (64281-110-05) / 1 KIT in 1 CARTON * 1 VIAL, PLASTIC in 1 KIT / 3 mL in 1 VIAL, PLASTIC (64281-113-00) * 1 VIAL, PLASTIC in 1 KIT / 3 mL in 1 VIAL, PLASTIC (64281-115-00) * 1 VIAL, PLASTIC in 1 KIT / 3 mL in 1 VIAL, PLASTIC (64281-114-00) * 1 VIAL, PLASTIC in 1 KIT / 3 mL in 1 VIAL, PLASTIC (64281-116-00) * 1 VIAL, PLASTIC in 1 KIT / 3 mL in 1 VIAL, PLASTIC (64281-112-00) * 1 VIAL, PLASTIC in 1 KIT / 3 mL in 1 VIAL, PLASTIC (64281-111-00)

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 64281-110-06 identifies a specific commercial package of 6 package in 1 package / 6 carton in 1 package (64281-110-05) / 1 kit in 1 carton * 1 vial, plastic in 1 kit / 3 ml in 1 vial, plastic (64281-113-00) * 1 vial, plastic in 1 kit / 3 ml in 1 vial, plastic (64281-115-00) * 1 vial, plastic in 1 kit / 3 ml in 1 vial, plastic (64281-114-00) * 1 vial, plastic in 1 kit / 3 ml in 1 vial, plastic (64281-116-00) * 1 vial, plastic in 1 kit / 3 ml in 1 vial, plastic (64281-112-00) * 1 vial, plastic in 1 kit / 3 ml in 1 vial, plastic (64281-111-00) of Provocholine Inhalation Solution, 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 March 03, 2022. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64281011006. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
64281-110-06
11-Digit CMS (5-4-2)
64281-0110-06

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