Pyridostigmine Bromide Powder
NDC Package 46016-1012-0

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 powders is pyridostigmine is used to improve muscle strength in patients with a certain muscle disease (myasthenia gravis). This formulation utilizes a powder delivery system. Marketed by Procos S.p.a., this product is identified by NDC 46016-1012.

Identification & Billing

NDC Package Code
46016-1012-0
Package Description
50 kg in 1 CONTAINER
Product Code
46016-1012
11-Digit Billing Format
46016101200

Clinical Specifications

Proprietary Name
Pyridostigmine Bromide
Non-Proprietary Name
Pyridostigmine Bromide
Substance Name
Pyridostigmine Bromide
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
PYRIDOSTIGMINE BROMIDE 50 kg/50kg
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
Procos S.p.a.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
11-12-2012
Listing Expiration
12-31-2026
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 46016-1012-0 identifies a specific commercial package of 50 kg in 1 container of Pyridostigmine Bromide (UNFINISHED drug), a bulk ingredient labeled by Procos S.p.a.. This powder 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 Procos S.p.a. on November 12, 2012. 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 Procos S.p.a. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 46016101200. 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 (5-4-1)
46016-1012-0
11-Digit CMS (5-4-2)
46016-1012-00

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