Mestinon Tablet, Extended Release
NDC Package 0187-3013-30

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

Package Information

Mestinon (pyridostigmine bromide) tablets is pyridostigmine is used to improve muscle strength in patients with a certain muscle disease (myasthenia gravis). This formulation utilizes a tablet, extended release delivery system. Marketed by Bausch Health Us, Llc, this product is identified by NDC 0187-3013 and is authorized under FDA application NDA011665.

Identification & Billing

NDC Package Code
0187-3013-30
Package Description
30 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
0187-3013
11-Digit Billing Format
00187301330
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Mestinon
Non-Proprietary Name
Pyridostigmine Bromide
Substance Name
Pyridostigmine Bromide
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PYRIDOSTIGMINE BROMIDE 180 mg/1
Pharmacologic Class
Usage Information
Pyridostigmine is used to improve muscle strength in patients with a certain muscle disease (myasthenia gravis). It works by preventing the breakdown of a certain natural substance (acetylcholine) in your body. Acetylcholine is needed for normal muscle function.

Regulatory & Marketing

Labeler Name
Bausch Health Us, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA011665
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-12-1959
Listing Expiration
12-31-2026
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 0187-3013-30 identifies a specific commercial package of 30 tablet, extended release in 1 bottle of Mestinon, a human prescription drug labeled by Bausch Health Us, Llc. This tablet, extended release is formulated for oral use and contains pyridostigmine bromide 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 Bausch Health Us, Llc on January 12, 1959. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Pyridostigmine is used to improve muscle strength in patients with a certain muscle disease (myasthenia gravis). It works by preventing the breakdown of a certain natural substance (acetylcholine) in your body. Acetylcholine is needed for normal muscle function.

How is this Bausch Health Us, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00187301330. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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 (4-4-2)
0187-3013-30
11-Digit CMS (5-4-2)
00187-3013-30

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