Vigafyde Solution
NDC Package 80789-003-15

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

Package Information

Vigafyde (vigabatrin) solution 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 solution delivery system. Marketed by Upsher-smith Laboratories, Llc, this product is identified by NDC 80789-003 and is authorized under FDA application NDA217684.

Identification & Billing

NDC Package Code
80789-003-15
Package Description
1 BOTTLE in 1 CARTON / 150 mL in 1 BOTTLE
Product Code
80789-003
11-Digit Billing Format
80789000315
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Vigafyde
Non-Proprietary Name
Vigabatrin
Substance Name
Vigabatrin
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
VIGABATRIN 100 mg/mL
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
Upsher-smith Laboratories, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA217684
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-18-2024
Listing Expiration
12-31-2027
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 80789-003-15 identifies a specific commercial package of 1 bottle in 1 carton / 150 ml in 1 bottle of Vigafyde, a human prescription drug labeled by Upsher-smith Laboratories, Llc. This solution 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 Upsher-smith Laboratories, Llc on June 18, 2024. The current certification is valid through December 31, 2027.

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 Upsher-smith Laboratories, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80789000315. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
80789-003-15
11-Digit CMS (5-4-2)
80789-0003-15

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