Zepatier Tablet, Film Coated
NDC Package 0006-3074-02

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Zepatier (elbasvir and grazoprevir) tablets is a medication used to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. This formulation utilizes a tablet, film coated delivery system. Marketed by Merck Sharp & Dohme Llc, this product is identified by NDC 0006-3074 and is authorized under FDA application NDA208261.

Identification & Billing

NDC Package Code
0006-3074-02
Package Description
2 DOSE PACK in 1 CARTON / 14 TABLET, FILM COATED in 1 DOSE PACK (0006-3074-01)
Product Code
0006-3074
11-Digit Billing Format
00006307402
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
2 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Zepatier
Non-Proprietary Name
Elbasvir And Grazoprevir
Substance Name
Elbasvir; Grazoprevir Anhydrous
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
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.

Regulatory & Marketing

Labeler Name
Merck Sharp & Dohme Llc
Product Type
Human Prescription Drug
FDA Application #
NDA208261
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-28-2016
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0006-3074-02 identifies a specific commercial package of 2 dose pack in 1 carton / 14 tablet, film coated in 1 dose pack (0006-3074-01) of Zepatier, a human prescription drug labeled by Merck Sharp & Dohme Llc. This tablet, film coated is formulated for oral use and contains elbasvir; grazoprevir anhydrous as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Merck Sharp & Dohme Llc on January 28, 2016. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

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.

How is this Merck Sharp & Dohme Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00006307402. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 2 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0006-3074-02
11-Digit CMS (5-4-2)
00006-3074-02

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.