Letermovir Injection, Solution
NDC Package 69497-0128-2

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Letermovir injection is a medication used to prevent disease caused by a virus called cytomegalovirus (CMV) in people who have received a bone marrow transplant. This formulation utilizes a injection, solution delivery system. Marketed by Msd Ireland (carlow), this product is identified by NDC 69497-0128.

Identification & Billing

NDC Package Code
69497-0128-2
Package Description
68 VIAL, SINGLE-DOSE in 1 TRAY / 24 mL in 1 VIAL, SINGLE-DOSE
Product Code
69497-0128
11-Digit Billing Format
69497012802

Clinical Specifications

Proprietary Name
Letermovir
Non-Proprietary Name
Letermovir
Substance Name
Letermovir
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Active Ingredient(s)
LETERMOVIR 20 mg/mL
Usage Information
This medication is used to prevent disease caused by a virus called cytomegalovirus (CMV) in people who have received a bone marrow transplant. CMV disease can lead to serious infections in the body, including an infection in the eye, called CMV retinitis, that can cause blindness. Letermovir is an anti-viral drug. It works by stopping the growth of the virus.

Regulatory & Marketing

Labeler Name
Msd Ireland (carlow)
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
11-08-2017
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 (69497-0128). Click a package code to view its specific billing and regulatory data.

69497-0128-1
68 VIAL, SINGLE-DOSE in 1 TRAY / 12 mL in 1 VIAL, SINGLE-DOSE

* 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 69497-0128-2 identifies a specific commercial package of 68 vial, single-dose in 1 tray / 24 ml in 1 vial, single-dose of Letermovir (UNFINISHED drug), drug for further processing labeled by Msd Ireland (carlow). This injection, solution is formulated for use and contains letermovir 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 Msd Ireland (carlow) on November 08, 2017. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to prevent disease caused by a virus called cytomegalovirus (CMV) in people who have received a bone marrow transplant. CMV disease can lead to serious infections in the body, including an infection in the eye, called CMV retinitis, that can cause blindness. Letermovir is an anti-viral drug. It works by stopping the growth of the virus.

How is this Msd Ireland (carlow) product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69497012802. 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)
69497-0128-2
11-Digit CMS (5-4-2)
69497-0128-02

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