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United States · US · US:72626-2701_314b9ef7-c6e5-44c9-9fbf-b0d35a24cd7d

Sofosbuvir and Velpatasvir

Orange BookUNIISPLATC J05AP

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAsegua Therapeutics LLC
CountryUS (United States)
ATC codeJ05AP
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7262627011
    2 BLISTER PACK in 1 CARTON (72626-2701-1) / 14 TABLET, FILM COATED in 1 BLISTER PACK

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": {
    "d0c1a945-4440-4b5c-81aa-693ed3db597c": {
      "match": "brand_token",
      "title": "SOFOSBUVIR AND VELPATASVIR (VELPATASVIR AND SOFOSBUVIR) TABLET, FILM COATED [ASEGUA THERAPEUTICS LLC]",
      "spl_version": "9",
      "published_date": "2025-03-10"
    }
  },
  "productid": "72626-2701_314b9ef7-c6e5-44c9-9fbf-b0d35a24cd7d",
  "productndc": "72626-2701",
  "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": "Sofosbuvir and Velpatasvir",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA208341",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Velpatasvir and Sofosbuvir",
  "start_marketing_date": "20181114",
  "active_numerator_strength": "400; 100"
}

Related drugs

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