Ganciclovir Sodium Injection, Powder, Lyophilized, For Solution
NDC Package 70436-231-55

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 Sodium injection is ganciclovir is an anti-viral drug. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Slate Run Pharmaceuticals, Llc, this product is identified by NDC 70436-231 and is authorized under FDA application ANDA204204.

Identification & Billing

NDC Package Code
70436-231-55
Package Description
25 VIAL in 1 CARTON / 10 mL in 1 VIAL
Product Code
70436-231
11-Digit Billing Format
70436023155
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 Sodium
Non-Proprietary Name
Ganciclovir Sodium
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 an anti-viral drug. It is used to prevent disease caused by a virus called cytomegalovirus (CMV) in people who have received organ or bone marrow transplants. CMV disease can lead to serious infections in the body, including an infection in the eye, called CMV retinitis, that can cause blindness. Ganciclovir is also used to treat people with weakened immune systems (including people with AIDS) who have CMV retinitis. Ganciclovir works by slowing the growth of the CMV virus. It helps control CMV retinitis and decrease the risk of blindness. It also helps prevent the spread of infection to other areas of the body. Ganciclovir is not a cure for CMV disease. Some people may have worsening CMV retinitis even with treatment. Therefore, it is important to have your eyes checked regularly by your doctor.

Regulatory & Marketing

Labeler Name
Slate Run Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA204204
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-01-2019
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: PDAC
INJECTION, GANCICLOVIR SODIUM, 500 MG
HCPCS Dosage 500 MG
Units / Pkg

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 70436-231-55 identifies a specific commercial package of 25 vial in 1 carton / 10 ml in 1 vial of Ganciclovir Sodium, a human prescription drug labeled by Slate Run Pharmaceuticals, Llc. 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 Slate Run Pharmaceuticals, Llc on January 01, 2019. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Ganciclovir is an anti-viral drug. It is used to prevent disease caused by a virus called cytomegalovirus (CMV) in people who have received organ or bone marrow transplants. CMV disease can lead to serious infections in the body, including an infection in the eye, called CMV retinitis, that can cause blindness. Ganciclovir is also used to treat people with weakened immune systems (including people with AIDS) who have CMV retinitis. Ganciclovir works by slowing the growth of the CMV virus. It helps control CMV retinitis and decrease the risk of blindness. It also helps prevent the spread of infection to other areas of the body. Ganciclovir is not a cure for CMV disease. Some people may have worsening CMV retinitis even with treatment. Therefore, it is important to have your eyes checked regularly by your doctor.

How is this Slate Run Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70436023155. 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)
70436-231-55
11-Digit CMS (5-4-2)
70436-0231-55

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