Prevymis Pellet
NDC 0006-5085
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Prevymis (letermovir) is a NDA-approved product labeled by Merck Sharp & Dohme Llc. This medication is used to prevent disease caused by a virus called cytomegalovirus (CMV) in people who have received a bone marrow transplant. It is supplied as a pellet for oral administration. This product entry covers the primary NDC 0006-5085 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
0006-5085
Proprietary Name:
Prevymis
Non-Proprietary Name: [1]
Letermovir
Substance Name: [2]
Letermovir
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Pellet
- A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
0006
Product Label ID:
FDA Application Number: [6]
NDA219104
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
08-30-2024
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 0006-5085?
The NDC code 0006-5085 is assigned by the FDA to the product Prevymis. It is commonly known by its generic name, letermovir. This pharmaceutical product is labeled by Merck Sharp & Dohme Llc and is currently categorized as listed product. The medication is a pellet administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 0006-5085-01. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
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.
What are Active Ingredients of this product?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
- LETERMOVIR 120 mg/1 - has antiviral activity; structure in first source
What is the NDC to RxNorm Crosswalk for this product?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
- RxCUI: 1988652 - letermovir 240 MG in 12 ML Injection
- RxCUI: 1988652 - 12 ML letermovir 20 MG/ML Injection
- RxCUI: 1988652 - letermovir 20 MG/ML per 12 ML Injection
- RxCUI: 1988652 - letermovir 240 MG per 12 ML Injection
- RxCUI: 1988657 - PREVYMIS 240 MG in 12 ML Injection
Which are the Pharmacologic Classes of this product?
A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.
- Cytochrome P450 2C19 Inducers - [MoA] (Mechanism of Action)
- Cytochrome P450 2C8 Inhibitors - [MoA] (Mechanism of Action)
- Cytochrome P450 2C9 Inducers - [MoA] (Mechanism of Action)
- Cytochrome P450 3A Inhibitors - [MoA] (Mechanism of Action)
- Cytomegalovirus DNA Terminase Complex Inhibitor - [EPC] (Established Pharmacologic Class)
- DNA Terminase Complex Inhibitors - [MoA] (Mechanism of Action)
- Organic Anion Transporting Polypeptide 1B1 Inhibitors - [MoA] (Mechanism of Action)
- Organic Anion Transporting Polypeptide 1B3 Inhibitors - [MoA] (Mechanism of Action)
* Please review the full disclaimer at the bottom of this page.
Patient Education
Letermovir
Letermovir is used to help prevent cytomegalovirus (CMV) infection and disease in certain people who have received a hematopoietic stem-cell transplant (HSCT; a procedure that replaces diseased bone marrow with healthy bone marrow) and are at increased risk of developing a CMV infection. Letermovir is in a class of medications called antivirals. It works by slowing the growth of CMV.
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* Please review the full disclaimer at the bottom of this page.
Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
