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United States · US · US:61958-2401_6ce7dd60-defa-4530-bff3-de03885e318a

Vosevi

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
    6195824011
    28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-2401-1)

Annotations

UNII (FDA Substance ID)
WJ6CA3ZU8B
SOFOSBUVIR
RxCUI 1484911
Orange Book
N209195
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": {
    "17ffc094-8ca7-45d2-80d8-fd043bc9a221": {
      "match": "brand_token",
      "title": "VOSEVI (SOFOSBUVIR, VELPATASVIR, AND VOXILAPREVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.]",
      "spl_version": "6",
      "published_date": "2025-07-25"
    }
  },
  "productid": "61958-2401_6ce7dd60-defa-4530-bff3-de03885e318a",
  "productndc": "61958-2401",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "209195",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "400MG;100MG;100MG",
        "product_no": "001",
        "approval_date": "Jul 18, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR",
  "proprietary_name": "Vosevi",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "NDA209195",
  "marketing_category": "NDA",
  "nonproprietary_name": "SOFOSBUVIR, VELPATASVIR, and VOXILAPREVIR",
  "start_marketing_date": "20170718",
  "active_numerator_strength": "400; 100; 100"
}

Related drugs

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