Home NDC 0006-3074 ZEPATIER
Product NDC 0006-3074
11-digit product format 000063074
Labeler code 0006
Product ID 0006-3074_227ae348-5f6f-44d8-a6dc-103e63d28102
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name elbasvir and grazoprevir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Merck Sharp & Dohme LLC
Application NDA208261
Marketing category NDA
Marketing start 2016-01-28
Substance ELBASVIR; GRAZOPREVIR ANHYDROUS
Active strength 50; 100 mg/1; mg/1
Pharmacologic classes 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]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N208261-001 ZEPATIER ELBASVIR; GRAZOPREVIR 50MG;100MG TABLET / ORAL RLD 2016-01-28
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208261-001 7973040 2029-07-24 U-1813 Drug substance, Drug product 2016-02-25 N208261-001 8871759 2031-05-04 U-1813 Drug substance, Drug product 2016-02-25
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N208261-001 ZEPATIER 50MG;100MG TABLET / ORAL RLD 2016-01-28 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N208261-001 7973040 2029-07-24 U-1813 Drug substance, Drug product 2016-02-25 a50c72e98297…2026-08-01 22:54:32 2026-06 N208261-001 8871759 2031-05-04 U-1813 Drug substance, Drug product 2016-02-25 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ZEPATIER ELBASVIR AND GRAZOPREVIR Merck Sharp & Dohme LLC 164dc02a-9180-426a-b8b5-04ab39d2bbd4 2026-03-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 208261 application number: NDA208261 ndc (product): 0006-3074
Additional Listing Data#
Finished product Yes
Brand name base ZEPATIER
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ELBASVIR 50 mg/1 GRAZOPREVIR ANHYDROUS 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 632L571YDK Internal UNII lookup 8YE81R1X1J Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1734636 Internal RxNorm lookup 1734642 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0006-3074-01 ZEPATIER 14 in 1 DOSE PACK TABLET, FILM COATED 14 22 0006-3074-02 ZEPATIER 2 in 1 CARTON TABLET, FILM COATED 2 22
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0006-3074 ZEPATIER (ELBASVIR AND GRAZOPREVIR) TABLET, FILM COATED [MERCK SHARP & DOHME LLC] 20 Current NDC, Legacy NDC, 2 package rows 20240713_164dc02a-9180-426a-b8b5-04ab39d2bbd4.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0006-3074-01 00006307401 14 in 1 DOSE PACK Historical 0006-3074-02 00006307402 2 DOSE PACK in 1 CARTON (0006-3074-02) / 14 TABLET, FILM COATED in 1 DOSE PACK (0006-3074-01) 2 dose pack 2016-01-28 0000-00-00 No No Current