Provocholine Powder, For Solution
NDC Package 64281-100-06

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

Package Information

Provocholine (methacholine chloride) powders is methacholine is used as a test to determine whether you may have asthma. This formulation utilizes a powder, for solution delivery system. Marketed by Methapharm Inc., this product is identified by NDC 64281-100 and is authorized under FDA application NDA019193.

Identification & Billing

NDC Package Code
64281-100-06
Package Description
6 VIAL, GLASS in 1 BOX / 100 mg in 1 VIAL, GLASS (64281-100-00)
Product Code
64281-100
11-Digit Billing Format
64281010006
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Provocholine
Non-Proprietary Name
Methacholine Chloride
Substance Name
Methacholine Chloride
Dosage Form
Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.
Administration Route
Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
Active Ingredient(s)
METHACHOLINE CHLORIDE 100 mg/100mg
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
03-27-2013
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J7674
Source: PDAC
METHACHOLINE CHLORIDE ADMINISTERED AS INHALATION SOLUTION THROUGH A NEBULIZER, PER 1 MG
HCPCS Dosage 1 MG
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 64281-100-06 identifies a specific commercial package of 6 vial, glass in 1 box / 100 mg in 1 vial, glass (64281-100-00) of Provocholine, a human prescription drug labeled by Methapharm Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This powder, for 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 March 27, 2013. 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: 64281010006. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
64281-100-06
11-Digit CMS (5-4-2)
64281-0100-06

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