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United States · US · US:61958-2201_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

  • ndc11
    6195822011
    28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-2201-1)

Annotations

UNII (FDA Substance ID)
WJ6CA3ZU8B
SOFOSBUVIR
RxCUI 1484911
Orange Book
N208341
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": "61958-2201_4e28b652-df20-450d-9f6e-4cc6e355e223",
  "productndc": "61958-2201",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "208341",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "400MG;100MG",
        "product_no": "001",
        "approval_date": "Jun 28, 2016"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "200MG;50MG",
        "product_no": "002",
        "approval_date": "Mar 19, 2020"
      }
    ],
    "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": "NDA208341",
  "marketing_category": "NDA",
  "nonproprietary_name": "Velpatasvir and Sofosbuvir",
  "start_marketing_date": "20160628",
  "active_numerator_strength": "400; 100"
}

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