Ganciclovir Injection, Powder, Lyophilized, For Solution
NDC Package 42023-173-25

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

Package Information

Ganciclovir injection is ganciclovir is used to treat herpes infection of the eye. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Endo Usa, Inc., this product is identified by NDC 42023-173 and is authorized under FDA application ANDA204950.

Identification & Billing

NDC Package Code
42023-173-25
Package Description
25 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE (42023-173-01)
Product Code
42023-173
11-Digit Billing Format
42023017325
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
Ganciclovir
Non-Proprietary Name
Ganciclovir
Substance Name
Ganciclovir Sodium
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
GANCICLOVIR SODIUM 500 mg/10mL
Pharmacologic Class
Usage Information
Ganciclovir is used to treat herpes infection of the eye. Although ganciclovir stops the growth of the virus, it is not a cure for the herpes infection. Herpes virus continues to live in the body even between outbreaks of infection. However, treating an outbreak may help the sores in the eye to heal faster and lower the risk of complications (such as decreased vision, blindness). Ganciclovir is an anti-viral drug. This medication treats only herpes eye infections. It will not work for other types of eye infections, such as those caused by bacteria. Unnecessary use or misuse of any anti-infective drug can lead to its decreased effectiveness.

Regulatory & Marketing

Labeler Name
Endo Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA204950
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-06-2016
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J1570
Source: ASP
Ganciclovir sodium injection
HCPCS Dosage 500 MG
Units / Pkg 25

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 42023-173-25 identifies a specific commercial package of 25 vial, single-dose in 1 carton / 10 ml in 1 vial, single-dose (42023-173-01) of Ganciclovir, a human prescription drug labeled by Endo Usa, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, powder, lyophilized, for solution is formulated for intravenous use and contains ganciclovir sodium 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 Endo Usa, Inc. on December 06, 2016. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Ganciclovir is used to treat herpes infection of the eye. Although ganciclovir stops the growth of the virus, it is not a cure for the herpes infection. Herpes virus continues to live in the body even between outbreaks of infection. However, treating an outbreak may help the sores in the eye to heal faster and lower the risk of complications (such as decreased vision, blindness). Ganciclovir is an anti-viral drug. This medication treats only herpes eye infections. It will not work for other types of eye infections, such as those caused by bacteria. Unnecessary use or misuse of any anti-infective drug can lead to its decreased effectiveness.

How is this Endo Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42023017325. 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)
42023-173-25
11-Digit CMS (5-4-2)
42023-0173-25

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