Pyridostigmine Bromide Granules Dc 16% Granule
NDC Package 57631-108-00

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Pyridostigmine Bromide Granules Dc 16% granules is pyridostigmine is used to improve muscle strength in patients with a certain muscle disease (myasthenia gravis). This formulation utilizes a granule delivery system. Marketed by Invatech Pharma Solutions Llc, this product is identified by NDC 57631-108.

Identification & Billing

NDC Package Code
57631-108-00
Package Description
7.5 GRANULE in 1 DRUM
Product Code
57631-108
11-Digit Billing Format
57631010800

Clinical Specifications

Proprietary Name
Pyridostigmine Bromide Granules Dc 16%
Non-Proprietary Name
Pyridostigmine Bromide Granules Dc 16%
Substance Name
Pyridostigmine Bromide
Dosage Form
Granule - A small particle or grain.
Active Ingredient(s)
PYRIDOSTIGMINE BROMIDE 30 mg/1
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
Invatech Pharma Solutions Llc
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
01-28-2019
Listing Expiration
12-31-2027
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 57631-108-00 identifies a specific commercial package of 7.5 granule in 1 drum of Pyridostigmine Bromide Granules Dc 16% (UNFINISHED drug), drug for further processing labeled by Invatech Pharma Solutions Llc. This granule is formulated for 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 Invatech Pharma Solutions Llc on January 28, 2019. The current certification is valid through December 31, 2027.

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 Invatech Pharma Solutions Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57631010800. 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)
57631-108-00
11-Digit CMS (5-4-2)
57631-0108-00

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