Vigabatrin
NDC Package 0591-3955-00

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. 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 Actavis Pharma, Inc., this product is identified by NDC 0591-3955 and is authorized under FDA application ANDA209824.

Identification & Billing

NDC Package Code
0591-3955-00
Package Description
10 mL in 1 BOX
Product Code
0591-3955
11-Digit Billing Format
00591395500

Clinical Specifications

Proprietary Name
Vigabatrin
Dosage Form
-
Active Ingredient(s)
VIGABATRIN 50 mg/mL
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
Actavis Pharma, Inc.
FDA Application #
ANDA209824
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-14-2020
End Marketing Date
01-31-2024
Listing Expiration
01-31-2024
Exclude Flag
D
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0591-3955). Click a package code to view its specific billing and regulatory data.

0591-3955-50
50 PACKET in 1 CARTON / 10 mL in 1 PACKET (0591-3955-11)

* 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 0591-3955-00 identifies a specific commercial package of 10 ml in 1 box of Vigabatrin, labeled by Actavis Pharma, Inc.. 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 Actavis Pharma, Inc. on May 14, 2020. The current certification is valid through January 31, 2024.

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 Actavis Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00591395500. 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)
0591-3955-00
11-Digit CMS (5-4-2)
00591-3955-00

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