Vistogard Granule
NDC Package 50633-220-04

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

Vistogard (uridine triacetate) granules is vISTOGARD® is indicated for the emergency treatment of adult and pediatric patients: following a fluorouracil or capecitabine overdose regardless of the presence of symptoms, orwho exhibit early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous system, and/or early-onset, unusually severe adverse reactions (e.g., gastrointestinal toxicity and/or neutropenia) within 96 hours following the end of fluorouracil or capecitabine administration. This formulation utilizes a granule delivery system. Marketed by Btg International Inc, this product is identified by NDC 50633-220 and is authorized under FDA application NDA208159.

Identification & Billing

NDC Package Code
50633-220-04
Package Description
4 PACKET in 1 CARTON / 10 g in 1 PACKET (50633-220-10)
Product Code
50633-220
11-Digit Billing Format
50633022004
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Vistogard
Non-Proprietary Name
Uridine Triacetate
Substance Name
Uridine Triacetate
Dosage Form
Granule - A small particle or grain.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
URIDINE TRIACETATE 951 mg/g
Pharmacologic Class
Usage Information
VISTOGARD® is indicated for the emergency treatment of adult and pediatric patients: following a fluorouracil or capecitabine overdose regardless of the presence of symptoms, orwho exhibit early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous system, and/or early-onset, unusually severe adverse reactions (e.g., gastrointestinal toxicity and/or neutropenia) within 96 hours following the end of fluorouracil or capecitabine administration.

Regulatory & Marketing

Labeler Name
Btg International Inc
Product Type
Human Prescription Drug
FDA Application #
NDA208159
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-31-2024
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (50633-220). Click a package code to view its specific billing and regulatory data.

50633-220-20
20 PACKET in 1 CARTON / 10 g in 1 PACKET (50633-220-10)

* 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 50633-220-04 identifies a specific commercial package of 4 packet in 1 carton / 10 g in 1 packet (50633-220-10) of Vistogard, a human prescription drug labeled by Btg International Inc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This granule is formulated for oral use and contains uridine triacetate 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 Btg International Inc on July 31, 2024. The current certification is valid through December 31, 2027.

How is this Btg International Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50633022004. 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)
50633-220-04
11-Digit CMS (5-4-2)
50633-0220-04

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