NDC 0006-3074

ZEPATIER

Elbasvir And Grazoprevir

ZEPATIER is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Elbasvir; Grazoprevir Anhydrous.

Product ID0006-3074_1496b16e-fbbf-46e5-b2e8-e983026663be
NDC0006-3074
Product TypeHuman Prescription Drug
Proprietary NameZEPATIER
Generic NameElbasvir And Grazoprevir
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-01-28
Marketing CategoryNDA / NDA
Application NumberNDA208261
Labeler NameMerck Sharp & Dohme Corp.
Substance NameELBASVIR; GRAZOPREVIR ANHYDROUS
Active Ingredient Strength50 mg/1; mg/1
Pharm ClassesHepatitis C Virus NS5A Inhibitor [EPC],Breast Cancer Resistance Protein Inhibitors [MoA],HCV NS3/4A Protease Inhibitors [MoA],Hepatitis C Virus NS3/4A Protease Inhibitor [EPC],Breast Cancer Resistance Protein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0006-3074-02

2 DOSE PACK in 1 CARTON (0006-3074-02) > 14 TABLET, FILM COATED in 1 DOSE PACK (0006-3074-01)
Marketing Start Date2016-01-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0006-3074-02 [00006307402]

ZEPATIER TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA208261
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-01-28

NDC 0006-3074-01 [00006307401]

ZEPATIER TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA208261
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-01-28

Drug Details

Active Ingredients

IngredientStrength
ELBASVIR50 mg/1

OpenFDA Data

SPL SET ID:164dc02a-9180-426a-b8b5-04ab39d2bbd4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1734642
  • 1734636
  • Pharmacological Class

    • Hepatitis C Virus NS5A Inhibitor [EPC]
    • Breast Cancer Resistance Protein Inhibitors [MoA]
    • HCV NS3/4A Protease Inhibitors [MoA]
    • Hepatitis C Virus NS3/4A Protease Inhibitor [EPC]
    • Breast Cancer Resistance Protein Inhibitors [MoA]
    • Cytochrome P450 3A Inhibitors [MoA]

    Trademark Results [ZEPATIER]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ZEPATIER
    ZEPATIER
    86336186 4937479 Live/Registered
    Merck Sharp & Dohme Corp.
    2014-07-14

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