zepatier

Generic: elbasvir and grazoprevir

Labeler: merck sharp & dohme llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zepatier
Generic Name elbasvir and grazoprevir
Labeler merck sharp & dohme llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

elbasvir 50 mg/1, grazoprevir anhydrous 100 mg/1

Manufacturer
Merck Sharp & Dohme LLC

Identifiers & Regulatory

Product NDC 0006-3074
Product ID 0006-3074_21d93204-5c90-4b70-aec4-f7e60b197fac
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208261
Listing Expiration 2026-12-31
Marketing Start 2016-01-28

Pharmacologic Class

Established (EPC)
hepatitis c virus ns5a inhibitor [epc] hepatitis c virus ns3/4a protease inhibitor [epc]
Mechanism of Action
breast cancer resistance protein inhibitors [moa] hcv ns3/4a protease inhibitors [moa] cytochrome p450 3a inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00063074
Hyphenated Format 0006-3074

Supplemental Identifiers

RxCUI
1734636 1734642
UNII
632L571YDK 8YE81R1X1J
NUI
N0000191256 N0000190113 N0000182638 N0000182639 N0000190114

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name zepatier (source: ndc)
Generic Name elbasvir and grazoprevir (source: ndc)
Application Number NDA208261 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
  • 100 mg/1
source: ndc
Packaging
  • 2 DOSE PACK in 1 CARTON (0006-3074-02) / 14 TABLET, FILM COATED in 1 DOSE PACK (0006-3074-01)
source: ndc

Packages (1)

0006-3074-02 2 DOSE PACK in 1 CARTON (0006-3074-02) / 14 TABLET, FILM COATED in 1 DOSE PACK (0006-3074-01)

Ingredients (2)

elbasvir (50 mg/1) grazoprevir anhydrous (100 mg/1)

Linked Drug Pages (1)

ZEPATIER ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "21d93204-5c90-4b70-aec4-f7e60b197fac", "openfda": {"nui": ["N0000191256", "N0000190113", "N0000182638", "N0000182639", "N0000190114"], "unii": ["632L571YDK", "8YE81R1X1J"], "rxcui": ["1734636", "1734642"], "spl_set_id": ["164dc02a-9180-426a-b8b5-04ab39d2bbd4"], "pharm_class_epc": ["Hepatitis C Virus NS5A Inhibitor [EPC]", "Hepatitis C Virus NS3/4A Protease Inhibitor [EPC]"], "pharm_class_moa": ["Breast Cancer Resistance Protein Inhibitors [MoA]", "HCV NS3/4A Protease Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]"], "manufacturer_name": ["Merck Sharp & Dohme LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 DOSE PACK in 1 CARTON (0006-3074-02)  / 14 TABLET, FILM COATED in 1 DOSE PACK (0006-3074-01)", "package_ndc": "0006-3074-02", "marketing_start_date": "20160128"}], "brand_name": "ZEPATIER", "product_id": "0006-3074_21d93204-5c90-4b70-aec4-f7e60b197fac", "dosage_form": "TABLET, FILM COATED", "pharm_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 Inhibitor [EPC]"], "product_ndc": "0006-3074", "generic_name": "elbasvir and grazoprevir", "labeler_name": "Merck Sharp & Dohme LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZEPATIER", "active_ingredients": [{"name": "ELBASVIR", "strength": "50 mg/1"}, {"name": "GRAZOPREVIR ANHYDROUS", "strength": "100 mg/1"}], "application_number": "NDA208261", "marketing_category": "NDA", "marketing_start_date": "20160128", "listing_expiration_date": "20261231"}