Amifampridine Phosphate Tablet
NDC Package 67651-0328-0

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.

Amifampridine Phosphate tablets is amifampridine phosphate is used to treat a certain disorder that affects nerves and muscles (Lambert-Eaton syndrome). This formulation utilizes a tablet delivery system. Marketed by Patheon Pharmaceuticals Inc., this product is identified by NDC 67651-0328.

Identification & Billing

NDC Package Code
67651-0328-0
Package Description
18000 TABLET in 1 DRUM
Product Code
67651-0328
11-Digit Billing Format
67651032800

Clinical Specifications

Proprietary Name
Amifampridine Phosphate
Non-Proprietary Name
Amifampridine Phosphate
Substance Name
Amifampridine Phosphate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Active Ingredient(s)
AMIFAMPRIDINE PHOSPHATE 10 mg/1
Usage Information
Amifampridine phosphate is used to treat a certain disorder that affects nerves and muscles (Lambert-Eaton syndrome). This disorder causes your body's immune system to attack healthy nerve cells, which results in muscle weakness. It is not known exactly how this medication works, but it can help lessen symptoms of muscle weakness and loss of movement caused by Lambert-Eaton syndrome.

Regulatory & Marketing

Labeler Name
Patheon Pharmaceuticals Inc.
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
01-07-2019
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 67651-0328-0 identifies a specific commercial package of 18000 tablet in 1 drum of Amifampridine Phosphate (UNFINISHED drug), drug for further processing labeled by Patheon Pharmaceuticals Inc.. This tablet is formulated for use and contains amifampridine phosphate 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 Patheon Pharmaceuticals Inc. on January 07, 2019. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Amifampridine phosphate is used to treat a certain disorder that affects nerves and muscles (Lambert-Eaton syndrome). This disorder causes your body's immune system to attack healthy nerve cells, which results in muscle weakness. It is not known exactly how this medication works, but it can help lessen symptoms of muscle weakness and loss of movement caused by Lambert-Eaton syndrome.

How is this Patheon Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67651032800. 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)
67651-0328-0
11-Digit CMS (5-4-2)
67651-0328-00

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