NDC 61958-1805 Harvoni
Ledipasvir And Sofosbuvir Pellet Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 61958 - Gilead Sciences, Inc
- 61958-1805 - Harvoni
Product Packages
NDC Code 61958-1805-1
Package Description: 90 PELLET in 1 PACKET
Product Details
What is NDC 61958-1805?
What are the uses for Harvoni?
What are Harvoni Active Ingredients?
- 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 Harvoni?
- 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 for Harvoni?
- 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)
- Nucleoside Analog - [EXT]
- P-Glycoprotein Inhibitors - [MoA] (Mechanism of Action)
- RNA Replicase Inhibitors - [MoA] (Mechanism of Action)
* Please review the disclaimer below.
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.
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* Please review the disclaimer below.
[1] 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.
[2] 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.
[3] 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.
[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.
[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.
[6] 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.
[8] 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.
[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.
[11] 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.
[12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".