Prevymis Injection, Solution
NDC Package 0006-5003-01

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

Package Information

Prevymis (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 Merck Sharp & Dohme Llc, this product is identified by NDC 0006-5003 and is authorized under FDA application NDA209940.

Identification & Billing

NDC Package Code
0006-5003-01
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 12 mL in 1 VIAL, SINGLE-DOSE (0006-5003-02)
Product Code
0006-5003
11-Digit Billing Format
00006500301
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Prevymis
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.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
LETERMOVIR 20 mg/mL
Pharmacologic Class
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
Merck Sharp & Dohme Llc
Product Type
Human Prescription Drug
FDA Application #
NDA209940
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-08-2017
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0006-5003-01 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 12 ml in 1 vial, single-dose (0006-5003-02) of Prevymis, a human prescription drug labeled by Merck Sharp & Dohme Llc. This injection, solution is formulated for intravenous 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 Merck Sharp & Dohme Llc on November 08, 2017. The current certification is valid through December 31, 2027.

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 Merck Sharp & Dohme Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00006500301. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (4-4-2)
0006-5003-01
11-Digit CMS (5-4-2)
00006-5003-01

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