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United States · US · US:61958-2005_12aff732-63cd-4d90-a329-7c3851e6b966

DESCOVY

Orange BookUNIISPLATC J05AF

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

Identification

ManufacturerGilead Sciences, Inc.
CountryUS (United States)
ATC codeJ05AF
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6195820051
    30 TABLET in 1 BOTTLE, PLASTIC (61958-2005-1)

Annotations

UNII (FDA Substance ID)
G70B4ETF4S
EMTRICITABINE
RxCUI 276237
Orange Book
N208215
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "G70B4ETF4S",
    "rxcui": "276237",
    "inchikey": "XQSPYNMVSIKCOC-NTSWFWBYSA-N",
    "display_name": "EMTRICITABINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "06f66e98-e6ee-4538-9506-6c1282cc14c1": {
      "match": "brand_token",
      "title": "DESCOVY (EMTRICITABINE AND TENOFOVIR ALAFENAMIDE) TABLET [GILEAD SCIENCES, INC.]",
      "spl_version": "12",
      "published_date": "2025-07-10"
    }
  },
  "productid": "61958-2005_12aff732-63cd-4d90-a329-7c3851e6b966",
  "productndc": "61958-2005",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "208215",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "200MG;EQ 25MG BASE",
        "product_no": "001",
        "approval_date": "Apr 4, 2016"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "120MG;EQ 15MG BASE",
        "product_no": "002",
        "approval_date": "Jan 7, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE",
  "proprietary_name": "DESCOVY",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA208215",
  "marketing_category": "NDA",
  "nonproprietary_name": "emtricitabine and tenofovir alafenamide",
  "start_marketing_date": "20220107",
  "active_numerator_strength": "120; 15"
}

Related drugs

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