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NDC 00006-3074-02 ZEPATIER 50; 100 mg/1; mg/1 Details
ZEPATIER 50; 100 mg/1; mg/1
ZEPATIER is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Merck Sharp & Dohme LLC. The primary component is ELBASVIR; GRAZOPREVIR ANHYDROUS.
MedlinePlus Drug Summary
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.
Related Packages: 00006-3074-02Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Elbasvir and Grazoprevir
Product Information
| NDC | 00006-3074 |
|---|---|
| Product ID | 0006-3074_194bbac3-2955-4d3f-ae5e-9da852e428fa |
| Associated GPIs | 12359902300320 |
| GCN Sequence Number | 075514 |
| GCN Sequence Number Description | elbasvir/grazoprevir TABLET 50MG-100MG ORAL |
| HIC3 | W0E |
| HIC3 Description | HEPATITIS C VIRUS- NS5A AND NS3/4A INHIBITOR COMB |
| GCN | 40615 |
| HICL Sequence Number | 043030 |
| HICL Sequence Number Description | ELBASVIR/GRAZOPREVIR |
| Brand/Generic | Brand |
| Proprietary Name | ZEPATIER |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | elbasvir and grazoprevir |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 50; 100 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | ELBASVIR; GRAZOPREVIR ANHYDROUS |
| Labeler Name | Merck Sharp & Dohme LLC |
| Pharmaceutical Class | Breast Cancer Resistance Protein Inhibitors [MoA], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HCV NS3/4A Protease Inhibitors [MoA], Hepatitis C Virus NS3/4A Protease Inhibitor [EPC], Hepatitis C Virus NS5A Inhi |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA208261 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00006-3074-02 (00006307402)
| NDC Package Code | 0006-3074-02 |
|---|---|
| Billing NDC | 00006307402 |
| Package | 2 DOSE PACK in 1 CARTON (0006-3074-02) / 14 TABLET, FILM COATED in 1 DOSE PACK (0006-3074-01) |
| Marketing Start Date | 2016-01-28 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |