Pyridostigmine Bromide
NDC Package 69784-130-01

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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Pyridostigmine Bromide is pyridostigmine is used to improve muscle strength in patients with a certain muscle disease (myasthenia gravis). Marketed by Woodward Pharma Services Llc, this product is identified by NDC 69784-130 and is authorized under FDA application ANDA212405.

Identification & Billing

NDC Package Code
69784-130-01
Package Description
473 mL in 1 BOTTLE
Product Code
69784-130
11-Digit Billing Format
69784013001

Clinical Specifications

Proprietary Name
Pyridostigmine Bromide
Dosage Form
-
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
Woodward Pharma Services Llc
FDA Application #
ANDA212405
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-15-2022
End Marketing Date
12-15-2022
Listing Expiration
12-15-2022
Exclude Flag
D
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 69784-130-01 identifies a specific commercial package of 473 ml in 1 bottle of Pyridostigmine Bromide, labeled by Woodward Pharma Services Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Woodward Pharma Services Llc on December 15, 2022. The current certification is valid through December 15, 2022.

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 Woodward Pharma Services Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69784013001. 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)
69784-130-01
11-Digit CMS (5-4-2)
69784-0130-01

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