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United States · US · US:61958-1901_7bb9d232-d878-47d0-8262-abc4d06b37f7

Genvoya

Orange BookUNIISPLATC V03AX

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

Identification

ManufacturerGilead Sciences, Inc.
CountryUS (United States)
ATC codeV03AX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6195819011
    30 TABLET in 1 BOTTLE, PLASTIC (61958-1901-1)

Annotations

UNII (FDA Substance ID)
LW2E03M5PG
COBICISTAT
RxCUI 1306284
Orange Book
N207561
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "LW2E03M5PG",
    "rxcui": "1306284",
    "inchikey": "ZCIGNRJZKPOIKD-CQXVEOKZSA-N",
    "display_name": "COBICISTAT",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "34784acf-15ed-4715-b504-eb30430518e9": {
      "match": "brand_token",
      "title": "GENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE) TABLET [GILEAD SCIENCES, INC.]",
      "spl_version": "22",
      "published_date": "2025-02-05"
    }
  },
  "productid": "61958-1901_7bb9d232-d878-47d0-8262-abc4d06b37f7",
  "productndc": "61958-1901",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "207561",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "150MG;150MG;200MG;EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Nov 5, 2015"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE",
  "proprietary_name": "Genvoya",
  "active_ingred_unit": "mg/1; mg/1; mg/1; mg/1",
  "application_number": "NDA207561",
  "marketing_category": "NDA",
  "nonproprietary_name": "elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide",
  "start_marketing_date": "20151105",
  "active_numerator_strength": "150; 150; 200; 10"
}

Related drugs

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