Vigabatrin
NDC Package 60219-1424-1

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.

Vigabatrin is used to treat babies, one month to 2 years old who have a condition known as infantile spasms. Marketed by Amneal Pharmaceuticals Ny Llc, this product is identified by NDC 60219-1424 and is authorized under FDA application ANDA210042.

Identification & Billing

NDC Package Code
60219-1424-1
Package Description
100 TABLET in 1 BOTTLE
Product Code
60219-1424
11-Digit Billing Format
60219142401

Clinical Specifications

Proprietary Name
Vigabatrin
Dosage Form
-
Usage Information
Vigabatrin is used to treat babies, one month to 2 years old who have a condition known as infantile spasms. Vigabatrin has also been used in combination with other medications to treat seizure disorders (epilepsy). Vigabatrin decreases the number of seizures in adults and children who have not been able to control their seizures with other treatment. Vigabatrin is an anticonvulsant. It is thought to work by stopping the breakdown of a natural calming substance (GABA) in the brain.

Regulatory & Marketing

Labeler Name
Amneal Pharmaceuticals Ny Llc
FDA Application #
ANDA210042
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-27-2023
End Marketing Date
02-06-2025
Listing Expiration
02-06-2025
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 60219-1424-1 identifies a specific commercial package of 100 tablet in 1 bottle of Vigabatrin, labeled by Amneal Pharmaceuticals Ny 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 Amneal Pharmaceuticals Ny Llc on April 27, 2023. The current certification is valid through February 06, 2025.

What are the primary indications for this medication?

Vigabatrin is used to treat babies, one month to 2 years old who have a condition known as infantile spasms. Vigabatrin has also been used in combination with other medications to treat seizure disorders (epilepsy). Vigabatrin decreases the number of seizures in adults and children who have not been able to control their seizures with other treatment. Vigabatrin is an anticonvulsant. It is thought to work by stopping the breakdown of a natural calming substance (GABA) in the brain.

How is this Amneal Pharmaceuticals Ny Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60219142401. 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)
60219-1424-1
11-Digit CMS (5-4-2)
60219-1424-01

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