NDC 0074-2625-01 Mavyret

Glecaprevir And Pibrentasvir

NDC Package Code 0074-2625-01

The NDC Code 0074-2625-01 is assigned to a package of 1 dose pack in 1 carton > 3 tablet, film coated in 1 dose pack of Mavyret, a human prescription drug labeled by Abbvie Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

Field Name Field Value
NDC Code 0074-2625-01
Package Description 1 DOSE PACK in 1 CARTON > 3 TABLET, FILM COATED in 1 DOSE PACK
Proprietary Name Mavyret What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Glecaprevir And Pibrentasvir 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.
Drug Uses This medication is a combination of glecaprevir and pibrentasvir and is used to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. Glecaprevir and pibrentasvir 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" (such as the use of latex condoms) to lower the risk of passing the virus to others.
11-Digit NDC Billing Format 00074262501 NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
Product Type Human Prescription Drug 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.
Labeler Name Abbvie Inc.
Dosage Form Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route(s)
  • Oral - Administration to or by way of the mouth.
Active Ingredient(s)
  • PIBRENTASVIR 40 mg/1
  • GLECAPREVIR 100 mg/1
Pharmacological Class(es)
  • Hepatitis C Virus NS5A Inhibitor - [EPC] (Established Pharmacologic Class)
  • P-Glycoprotein Inhibitors - [MoA] (Mechanism of Action)
  • Breast Cancer Resistance Protein 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)
  • Cytochrome P450 3A Inhibitors - [MoA] (Mechanism of Action)
  • Cytochrome P450 1A2 Inhibitors - [MoA] (Mechanism of Action)
  • UGT1A1 Inhibitors - [MoA] (Mechanism of Action)
  • Hepatitis C Virus NS3/4A Protease Inhibitor - [EPC] (Established Pharmacologic Class)
  • HCV NS3/4A Protease Inhibitors - [MoA] (Mechanism of Action)
  • P-Glycoprotein Inhibitors - [MoA] (Mechanism of Action)
  • Breast Cancer Resistance Protein 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)
  • Cytochrome P450 3A Inhibitors - [MoA] (Mechanism of Action)
  • Cytochrome P450 1A2 Inhibitors - [MoA] (Mechanism of Action)
  • UGT1A1 Inhibitors - [MoA] (Mechanism of Action)
Sample Package No Sample Package?
This field Indicates whether this package is a sample packaging or not.
Marketing Category NDA - A product marketed under an approved New Drug Application. 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.
FDA Application Number NDA209394 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.
Start Marketing Date 08-03-2017 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date 12-31-2022 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.
Exclude Flag N 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".

NDC Code Structure

  • 0074 - Abbvie Inc.
    • 0074-2625 - Mavyret
      • 0074-2625-01 - 1 DOSE PACK in 1 CARTON

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 disclaimer below.

Other Product Packages

The following packages are also available for Mavyret with product NDC 0074-2625.

NDC Package CodePackage Description
0074-2625-284 CARTON in 1 CARTON > 7 DOSE PACK in 1 CARTON > 3 TABLET, FILM COATED in 1 DOSE PACK
0074-2625-562 CARTON in 1 CARTON > 4 CARTON in 1 CARTON > 7 DOSE PACK in 1 CARTON > 3 TABLET, FILM COATED in 1 DOSE PACK
0074-2625-8084 TABLET, FILM COATED in 1 BOTTLE

* Please review the disclaimer below.