Vigabatrin Powder, For Solution
NDC Package 43598-697-50

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

Package Information

Vigabatrin powders 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 powder, for solution delivery system. Marketed by Dr. Reddy�s Laboratories Inc.,, this product is identified by NDC 43598-697 and is authorized under FDA application ANDA211481.

Identification & Billing

NDC Package Code
43598-697-50
Package Description
50 PACKET in 1 CARTON / 10 mL in 1 PACKET (43598-697-11)
Product Code
43598-697
11-Digit Billing Format
43598069750
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
RxCUI: 250820 - vigabatrin 500 MG Powder for Oral Solution

Clinical Specifications

Proprietary Name
Vigabatrin
Non-Proprietary Name
Vigabatrin
Substance Name
Vigabatrin
Dosage Form
Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
VIGABATRIN 50 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
Dr. Reddy�s Laboratories Inc.,
Product Type
Human Prescription Drug
FDA Application #
ANDA211481
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-21-2018
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 43598-697-50 identifies a specific commercial package of 50 packet in 1 carton / 10 ml in 1 packet (43598-697-11) of Vigabatrin, a human prescription drug labeled by Dr. Reddy�s Laboratories Inc.,. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This powder, for 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 Dr. Reddy�s Laboratories Inc., on November 21, 2018. 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 Dr. Reddy�s Laboratories Inc., product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43598069750. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
43598-697-50
11-Digit CMS (5-4-2)
43598-0697-50

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