Pyridostigmine Bromide Solution
NDC Package 68682-307-05

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

Package Information

Pyridostigmine Bromide solution is pyridostigmine is used to improve muscle strength in patients with a certain muscle disease (myasthenia gravis). This formulation utilizes a solution delivery system. Marketed by Oceanside Pharmaceuticals, this product is identified by NDC 68682-307 and is authorized under FDA application NDA015193.

Identification & Billing

NDC Package Code
68682-307-05
Package Description
473 mL in 1 BOTTLE
Product Code
68682-307
11-Digit Billing Format
68682030705
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
473 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Pyridostigmine Bromide
Non-Proprietary Name
Pyridostigmine Bromide
Substance Name
Pyridostigmine Bromide
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PYRIDOSTIGMINE BROMIDE 60 mg/5mL
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
Oceanside Pharmaceuticals
Product Type
Human Prescription Drug
FDA Application #
NDA015193
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
07-01-2019
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68682-307-05 identifies a specific commercial package of 473 ml in 1 bottle of Pyridostigmine Bromide, a human prescription drug labeled by Oceanside Pharmaceuticals. This solution 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 Oceanside Pharmaceuticals on July 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 Oceanside Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68682030705. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 473 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 (5-3-2)
68682-307-05
11-Digit CMS (5-4-2)
68682-0307-05

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