🇺🇸
United States · US · US:0006-3074_227ae348-5f6f-44d8-a6dc-103e63d28102
ZEPATIER
In shortageOrange BookUNIISPLATC J05AP
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMerck Sharp & Dohme LLC
CountryUS (United States)
ATC codeJ05AP
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1100063074022 DOSE PACK in 1 CARTON (0006-3074-02) / 14 TABLET, FILM COATED in 1 DOSE PACK (0006-3074-01)
Annotations
UNII (FDA Substance ID)
632L571YDK
ELBASVIR
RxCUI 1734628
Orange Book
N208261
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Elbasvir; Grazoprevir Tablet
Raw payload (JSON)
{
"unii": {
"unii": "632L571YDK",
"rxcui": "1734628",
"inchikey": "BVAZQCUMNICBAQ-PZHYSIFUSA-N",
"display_name": "ELBASVIR",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"164dc02a-9180-426a-b8b5-04ab39d2bbd4": {
"match": "brand_token",
"title": "ZEPATIER (ELBASVIR AND GRAZOPREVIR) TABLET, FILM COATED [MERCK SHARP & DOHME LLC]",
"spl_version": "22",
"published_date": "2026-03-23"
}
},
"productid": "0006-3074_227ae348-5f6f-44d8-a6dc-103e63d28102",
"productndc": "0006-3074",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "208261",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "50MG;100MG",
"product_no": "001",
"approval_date": "Jan 28, 2016"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ELBASVIR; GRAZOPREVIR ANHYDROUS",
"shortage_reason": "Elbasvir; Grazoprevir Tablet",
"shortage_status": "current",
"proprietary_name": "ZEPATIER",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA208261",
"marketing_category": "NDA",
"nonproprietary_name": "elbasvir and grazoprevir",
"start_marketing_date": "20160128",
"active_numerator_strength": "50; 100"
}Related drugs
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