Vigabatrin Tablet
NDC Package 42799-950-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Vigabatrin tablets is vigabatrin is used to treat babies, one month to 2 years old who have a condition known as infantile spasms. This formulation utilizes a tablet delivery system. Marketed by Edenbridge Pharmaceuticals Llc., this product is identified by NDC 42799-950 and is authorized under FDA application ANDA215109.

Identification & Billing

NDC Package Code
42799-950-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
42799-950
11-Digit Billing Format
42799095001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
RxCUI: 199521 - vigabatrin 500 MG Oral Tablet

Clinical Specifications

Proprietary Name
Vigabatrin
Non-Proprietary Name
Vigabatrin
Substance Name
Vigabatrin
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
VIGABATRIN 500 mg/1
Pharmacologic Class
Anti-epileptic Agent - [EPC] (Established Pharmacologic Class)
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
Edenbridge Pharmaceuticals Llc.
Product Type
Human Prescription Drug
FDA Application #
ANDA215109
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-29-2022
Listing Expiration
12-31-2026
Exclude Flag
N
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 42799-950-01 identifies a specific commercial package of 100 tablet in 1 bottle of Vigabatrin, a human prescription drug labeled by Edenbridge Pharmaceuticals Llc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package. This tablet is formulated for oral use and contains vigabatrin 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 Edenbridge Pharmaceuticals Llc. on June 29, 2022. The current certification is valid through December 31, 2026.

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 Edenbridge Pharmaceuticals Llc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42799095001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
42799-950-01
11-Digit CMS (5-4-2)
42799-0950-01

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