Vigabatrin
NDC Package 16729-521-11

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 Accord Healthcare Inc., this product is identified by NDC 16729-521 and is authorized under FDA application ANDA214425.

Identification & Billing

NDC Package Code
16729-521-11
Package Description
50 POWDER, FOR SOLUTION in 1 CARTON
Product Code
16729-521
11-Digit Billing Format
16729052111
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
50 EA

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
Accord Healthcare Inc.
FDA Application #
ANDA214425
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-28-2021
End Marketing Date
02-28-2023
Listing Expiration
02-28-2023
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 16729-521-11 identifies a specific commercial package of 50 powder, for solution in 1 carton of Vigabatrin, labeled by Accord Healthcare Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 50 billable units per package. 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 Accord Healthcare Inc. on April 28, 2021. The current certification is valid through February 28, 2023.

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 Accord Healthcare Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16729052111. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 50 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)
16729-521-11
11-Digit CMS (5-4-2)
16729-0521-11

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