Regonol Injection, Solution
NDC Package 0781-3040-95

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

Package Information

Regonol (pyridostigmine bromide) injection is pyridostigmine is used to improve muscle strength in patients with a certain muscle disease (myasthenia gravis). This formulation utilizes a injection, solution delivery system. Marketed by Sandoz Inc, this product is identified by NDC 0781-3040 and is authorized under FDA application NDA017398.

Identification & Billing

NDC Package Code
0781-3040-95
Package Description
10 AMPULE in 1 CARTON / 2 mL in 1 AMPULE (0781-3040-72)
Product Code
0781-3040
11-Digit Billing Format
00781304095
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Regonol
Non-Proprietary Name
Pyridostigmine Bromide
Substance Name
Pyridostigmine Bromide
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
  • Intravenous - Administration within or into a vein or veins.
  • Parenteral - Administration by injection, infusion, or implantation.
Active Ingredient(s)
PYRIDOSTIGMINE BROMIDE 5 mg/mL
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
Sandoz Inc
Product Type
Human Prescription Drug
FDA Application #
NDA017398
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-10-2005
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 0781-3040-95 identifies a specific commercial package of 10 ampule in 1 carton / 2 ml in 1 ampule (0781-3040-72) of Regonol, a human prescription drug labeled by Sandoz Inc. This injection, solution is formulated for intravenous; parenteral 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 Sandoz Inc on May 10, 2005. 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 Sandoz Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00781304095. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
0781-3040-95
11-Digit CMS (5-4-2)
00781-3040-95

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