FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
ZEPATIER
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ELBASVIR50 mg/1
GRAZOPREVIR ANHYDROUS100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii632L571YDK, 8YE81R1X1J
Rxcui1734636, 1734642

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
5f3efb1b-b5d2-4e4f-b00d-591593cf9cadProduct name120160412
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0006-3074-022024-01-30C16284748780-11030e365-3199-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ZEPATIER safely and effectively. See full prescribing information for ZEPATIER. ZEPATIER ® (elbasvir and grazoprevir) tablets, for oral use Initial U.S. Approval: 2016
0006-3074-022024-01-30C16284748780-11030e365-3199-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ZEPATIER safely and effectively. See full prescribing information for ZEPATIER. ZEPATIER ® (elbasvir and grazoprevir) tablets, for oral use Initial U.S. Approval: 2016
0006-3074-022024-01-30C16284748780-11030e365-3199-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ZEPATIER safely and effectively. See full prescribing information for ZEPATIER. ZEPATIER ® (elbasvir and grazoprevir) tablets, for oral use Initial U.S. Approval: 2016

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0006-3074-01ZEPATIER14 in 1 DOSE PACKTABLET, FILM COATED1422
0006-3074-02ZEPATIER2 in 1 CARTONTABLET, FILM COATED222

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-3074-01EA - Each0006-3074ebd4b458-b786-4313-bf95-207cbfac3a4f12016-03-04
0006-3074-02EA - Each0006-3074ca7f83dc-cc0c-44cc-9c71-94737912a67012016-02-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-3074ZEPATIER (ELBASVIR AND GRAZOPREVIR) TABLET, FILM COATED [MERCK SHARP & DOHME LLC]20Current NDC, Legacy NDC, 2 package rows20240713_164dc02a-9180-426a-b8b5-04ab39d2bbd4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734636elbasvir 50 MG / grazoprevir 100 MG Oral TabletPSN164dc02a-9180-426a-b8b5-04ab39d2bbd422
1734642Zepatier 50 MG / 100 MG Oral TabletPSN164dc02a-9180-426a-b8b5-04ab39d2bbd422
1734642elbasvir 50 MG / grazoprevir 100 MG Oral Tablet [Zepatier]SBD164dc02a-9180-426a-b8b5-04ab39d2bbd422
1734636elbasvir 50 MG / grazoprevir 100 MG Oral TabletSCD164dc02a-9180-426a-b8b5-04ab39d2bbd422
1734642Zepatier (elbasvir 50 MG / grazoprevir 100 MG) Oral TabletSY164dc02a-9180-426a-b8b5-04ab39d2bbd422

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0006-3074-010000630740114 in 1 DOSE PACKHistorical
0006-3074-02000063074022 DOSE PACK in 1 CARTON (0006-3074-02) / 14 TABLET, FILM COATED in 1 DOSE PACK (0006-3074-01) 2 dose pack2016-01-280000-00-00NoNoCurrent