Pyridostigmine Bromide Tablet
NDC Package 58657-810-30

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

Package Information

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 delivery system. Marketed by Method Pharmaceuticals, Llc, this product is identified by NDC 58657-810 and is authorized under FDA application ANDA211181.

Identification & Billing

NDC Package Code
58657-810-30
Package Description
30 CARTON in 1 CARTON / 3 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK
Product Code
58657-810
11-Digit Billing Format
58657081030
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Pyridostigmine Bromide
Non-Proprietary Name
Pyridostigmine Bromide
Substance Name
Pyridostigmine Bromide
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PYRIDOSTIGMINE BROMIDE 30 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
Method Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA211181
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-01-2019
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (58657-810). Click a package code to view its specific billing and regulatory data.

58657-810-10
21 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK
58657-810-21
21 TABLET in 1 BOTTLE

* 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 58657-810-30 identifies a specific commercial package of 30 carton in 1 carton / 3 blister pack in 1 carton / 10 tablet in 1 blister pack of Pyridostigmine Bromide, a human prescription drug labeled by Method Pharmaceuticals, Llc. This tablet 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 Method Pharmaceuticals, Llc on June 01, 2019. 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 Method Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58657081030. 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)
58657-810-30
11-Digit CMS (5-4-2)
58657-0810-30

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