Harvoni Pellet
NDC 61958-1805
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Harvoni (ledipasvir and sofosbuvir) is a NDA-approved product labeled by Gilead Sciences, Inc. This medication is a combination of ledipasvir and sofosbuvir and is used to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. It is supplied as a pellet for oral administration. This product entry covers the primary NDC 61958-1805 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
61958-1805
Proprietary Name:
Harvoni
Non-Proprietary Name: [1]
Ledipasvir And Sofosbuvir
Substance Name: [2]
Ledipasvir; Sofosbuvir
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:
61958
Product Label ID:
FDA Application Number: [6]
NDA212477
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
08-28-2019
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 61958-1805?
The NDC code 61958-1805 is assigned by the FDA to the product Harvoni. It is commonly known by its generic name, ledipasvir and sofosbuvir. This pharmaceutical product is labeled by Gilead Sciences, Inc 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: 61958-1805-1. 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 a combination of ledipasvir and sofosbuvir and is used to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. It may sometimes be used with another antiviral medication (ribavirin). These drugs work by reducing the amount of hepatitis C virus in your body, which helps your immune system fight the infection and may help your liver recover. Chronic hepatitis C infection can cause serious liver problems such as scarring (cirrhosis), or liver cancer. It is not known if this treatment can prevent you from passing the virus to others. Do not share needles, and practice "safer sex" (including the use of latex condoms) to lower the risk of passing the virus to others.
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.
- LEDIPASVIR 33.75 mg/1
- SOFOSBUVIR 150 mg/1 - A uridine monophosphate analog inhibitor of HEPATITIS C VIRUS (HCV) polymerase NS5B that is used as an ANTIVIRAL AGENT in the treatment of CHRONIC HEPATITIS C.
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: 1591943 - ledipasvir 90 MG / sofosbuvir 400 MG Oral Tablet
- RxCUI: 1591949 - Harvoni 90 MG / 400 MG Oral Tablet
- RxCUI: 1591949 - ledipasvir 90 MG / sofosbuvir 400 MG Oral Tablet [Harvoni]
- RxCUI: 1591949 - Harvoni (ledipasvir 90 MG / sofosbuvir 400 MG) Oral Tablet
- RxCUI: 2203895 - ledipasvir 45 MG / sofosbuvir 200 MG Oral Tablet
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.
- Breast Cancer Resistance Protein Inhibitors - [MoA] (Mechanism of Action)
- Hepatitis C Virus NS5A Inhibitor - [EPC] (Established Pharmacologic Class)
- Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor - [EPC] (Established Pharmacologic Class)
- P-Glycoprotein Inhibitors - [MoA] (Mechanism of Action)
- RNA Replicase Inhibitors - [MoA] (Mechanism of Action)
* Please review the full disclaimer at the bottom of this page.
Patient Education
Ledipasvir and Sofosbuvir
The combination of ledipasvir and sofosbuvir is used alone or in combination with ribavirin (Copegus, Rebetol, Ribasphere, others) to treat certain types of chronic hepatitis C (an ongoing viral infection that damages the liver) in adults and children 3 years of age and older. Sofosbuvir is in a class of antiviral medications called nucleotide polymerase inhibitors. It works by decreasing the amount of hepatitis C virus (HCV) in the body. Ledipasvir is in a class of antiviral medications called HCV NS5A inhibitors. It works by stopping the virus that causes hepatitis C from spreading inside the body.
[Learn More]
* 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".
