Ganciclovir
NDC Package 51754-2500-1

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Ganciclovir is iNJECTION is contraindicated in patients who have experienced a clinically significant hypersensitivity reaction (e.g., anaphylaxis) to ganciclovir, valganciclovir or acyclovir. Marketed by Exela Pharma Sciences, Llc, this product is identified by NDC 51754-2500 and is authorized under FDA application NDA209347.

Identification & Billing

NDC Package Code
51754-2500-1
Package Description
250 mL in 1 BAG
Product Code
51754-2500
11-Digit Billing Format
51754250001
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
250 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ganciclovir
Dosage Form
-
Usage Information
GANCICLOVIR INJECTION is contraindicated in patients who have experienced a clinically significant hypersensitivity reaction (e.g., anaphylaxis) to ganciclovir, valganciclovir or acyclovir.

Regulatory & Marketing

Labeler Name
Exela Pharma Sciences, Llc
FDA Application #
NDA209347
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-28-2017
Listing Expiration
12-31-2025
Exclude Flag
I
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 (51754-2500). Click a package code to view its specific billing and regulatory data.

51754-2500-3
10 BAG in 1 POUCH / 250 mL in 1 BAG

* 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 51754-2500-1 identifies a specific commercial package of 250 ml in 1 bag of Ganciclovir, labeled by Exela Pharma Sciences, Llc. This product is billed per "ML" milliliter and contains an estimated amount of 250 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 Exela Pharma Sciences, Llc on February 28, 2017. The current certification is valid through December 31, 2025.

How is this Exela Pharma Sciences, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51754250001. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 250 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 (5-4-1)
51754-2500-1
11-Digit CMS (5-4-2)
51754-2500-01

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