🇺🇸
United States · US · US:61958-2205_4e28b652-df20-450d-9f6e-4cc6e355e223
Epclusa
Orange BookUNIISPLATC J05AP
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGilead Sciences, Inc.
CountryUS (United States)
ATC codeJ05AP
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11619582205128 PACKET in 1 CARTON (61958-2205-1) / 1 PELLET in 1 PACKET
Annotations
UNII (FDA Substance ID)
WJ6CA3ZU8B
SOFOSBUVIR
RxCUI 1484911
Orange Book
N214187
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "WJ6CA3ZU8B",
"rxcui": "1484911",
"inchikey": "TTZHDVOVKQGIBA-IQWMDFIBSA-N",
"display_name": "SOFOSBUVIR",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"996466df-f236-4804-b10f-838aa83231a1": {
"match": "brand_token",
"title": "EPCLUSA ACCESS (VELPATASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.]",
"spl_version": "6",
"published_date": "2025-04-28"
}
},
"productid": "61958-2205_4e28b652-df20-450d-9f6e-4cc6e355e223",
"productndc": "61958-2205",
"dosage_form": "PELLET",
"orange_book": {
"appl_no": "214187",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "150MG;37.5MG/PACKET",
"product_no": "001",
"approval_date": "Jun 10, 2021"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "200MG;50MG/PACKET",
"product_no": "002",
"approval_date": "Jun 10, 2021"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SOFOSBUVIR; VELPATASVIR",
"proprietary_name": "Epclusa",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA214187",
"marketing_category": "NDA",
"nonproprietary_name": "Velpatasvir and Sofosbuvir",
"start_marketing_date": "20210610",
"active_numerator_strength": "150; 37.5"
}Related drugs
Other records sharing ATC code J05AP.
- 🇺🇸EpclusaGilead Sciences, Inc.
- 🇺🇸EpclusaGilead Sciences, Inc.
- 🇺🇸EpclusaGilead Sciences, Inc.
- 🇪🇸EPCLUSA 150 MG/37,5 MG GRANULADO RECUBIERTO EN SOBREGilead Sciences Ireland Unlimited Company
- 🇫🇷EPCLUSA 150 mg/37,5 mg, granulés enrobés en sachetGILEAD SCIENCES IRELAND UC (IRLANDE)
- GBEpclusa 150mg/37.5mg granules sachetsGilead Sciences Ltd
- 🇪🇸EPCLUSA 200 MG/50 MG GRANULADO RECUBIERTO EN SOBREGilead Sciences Ireland Unlimited Company
- 🇫🇷EPCLUSA 200 mg/50 mg, comprimé pelliculéGILEAD SCIENCES IRELAND UC (IRLANDE)
Access this data programmatically
Query Epclusa and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.