Provocholine Inhalation Solution
NDC Package 64281-116-12

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) solution is methacholine is used as a test to determine whether you may have asthma. This formulation utilizes a solution delivery system. Marketed by Methapharm Inc., this product is identified by NDC 64281-116 and is authorized under FDA application NDA019193.

Identification & Billing

NDC Package Code
64281-116-12
Package Description
2 CARTON in 1 CARTON / 6 VIAL, PLASTIC in 1 CARTON (64281-116-06) / 3 mL in 1 VIAL, PLASTIC (64281-116-00)
Product Code
64281-116
11-Digit Billing Format
64281011612

Clinical Specifications

Proprietary Name
Provocholine Inhalation Solution
Non-Proprietary Name
Methacholine Chloride Inhalation Solution
Substance Name
Methacholine Chloride
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
Active Ingredient(s)
METHACHOLINE CHLORIDE 48 mg/3mL
Pharmacologic Class
Usage Information
Methacholine is used as a test to determine whether you may have asthma. It is a cholinergic drug that causes wheezing and shortness of breath.

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
04-14-2026
Listing Expiration
12-31-2027
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 64281-116-12 identifies a specific commercial package of 2 carton in 1 carton / 6 vial, plastic in 1 carton (64281-116-06) / 3 ml in 1 vial, plastic (64281-116-00) of Provocholine Inhalation Solution, a human prescription drug labeled by Methapharm Inc.. This solution is formulated for respiratory (inhalation) use and contains methacholine chloride 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 April 14, 2026. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Methacholine is used as a test to determine whether you may have asthma. It is a cholinergic drug that causes wheezing and shortness of breath.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64281011612. 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)
64281-116-12
11-Digit CMS (5-4-2)
64281-0116-12

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