NDC 0006-3074 Zepatier
Elbasvir And Grazoprevir Tablet, Film Coated Oral

Table of Contents

    1. Product Information
    2. Product Packages
    3. Product Characteristics
    4. What is NDC 0006-3074?
    5. Zepatier Uses
    6. Active Ingredients
    7. Active Ingredients UNII Codes
    8. Inactive Ingredients UNII Codes
    9. NDC to RxNorm Crosswalk
    10. Pharmacologic Classes
    11. Patient Education

Product Information

NDC Product Code0006-3074
Proprietary Name 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.		Zepatier
Non-Proprietary Name 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.		Elbasvir And Grazoprevir
Substance Name 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.		Elbasvir; Grazoprevir Anhydrous
Product Type 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.		Human Prescription Drug
NDC Directory StatusACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage FormTablet, 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) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Merck Sharp & Dohme Llc
Labeler Code0006
SPL SET ID:164dc02a-9180-426a-b8b5-04ab39d2bbd4
FDA Application Number 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.		NDA208261
Marketing Category 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.		NDA - A product marketed under an approved New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		01-28-2016
Listing Expiration Date 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.		12-31-2023
Exclude Flag 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". 		N
NDC Code Structure

Product Characteristics

Color(s)BROWN (C48332 - BEIGE)
ShapeOVAL (C48345)
Size(s)21 MM
Imprint(s)770
Score1

Product Packages

NDC Code 0006-3074-02

Package Description: 2 DOSE PACK in 1 CARTON / 14 TABLET, FILM COATED in 1 DOSE PACK (0006-3074-01)

Price per Unit: $634.23750 per EA

Product Details

What is NDC 0006-3074?

The NDC code 0006-3074 is assigned by the FDA to the product Zepatier which is a human prescription drug product labeled by Merck Sharp & Dohme Llc. The generic name of Zepatier is elbasvir and grazoprevir. The product's dosage form is tablet, film coated and is administered via oral form. The product is distributed in a single package with assigned NDC code 0006-3074-02 2 dose pack in 1 carton / 14 tablet, film coated in 1 dose pack (0006-3074-01). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Zepatier?

This medication is used to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. Elbasvir and grazoprevir 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. This product may also be used with certain other medications (such as ribavirin). 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 Zepatier Active Ingredients?

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.

Which are Zepatier UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Zepatier Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Zepatier?

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:

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Patient Education

Elbasvir and Grazoprevir


The combination of elbasvir and grazoprevir is used alone or in combination with ribavirin (Copegus, Rebetol, Ribasphere, Virazole) to treat a certain type of chronic (long-term) hepatitis C infection (swelling of the liver caused by a virus) in adults and children 12 years of age or older. Elbasvir 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. Grazoprevir is in a class of medications called protease inhibitors. It works by decreasing the amount of hepatitis C virus (HCV) in the body. It is not known if elbasvir and grazoprevir prevent the spread of hepatitis C to other people.
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Product Label

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