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United States · US · US:61958-2101_130b8bbc-f660-40ff-831c-139734f90b99

ODEFSEY

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
    6195821011
    30 TABLET in 1 BOTTLE, PLASTIC (61958-2101-1)

Annotations

UNII (FDA Substance ID)
G70B4ETF4S
EMTRICITABINE
RxCUI 276237
Orange Book
N208351
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": {
    "ea3b9ec8-e04a-412c-8b3f-e5cbc7e641d5": {
      "match": "brand_token",
      "title": "ODEFSEY (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR ALAFENAMIDE) TABLET [GILEAD SCIENCES, INC.]",
      "spl_version": "13",
      "published_date": "2025-12-10"
    }
  },
  "productid": "61958-2101_130b8bbc-f660-40ff-831c-139734f90b99",
  "productndc": "61958-2101",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "208351",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "200MG;EQ 25MG BASE;EQ 25MG BASE",
        "product_no": "001",
        "approval_date": "Mar 1, 2016"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE",
  "proprietary_name": "ODEFSEY",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "NDA208351",
  "marketing_category": "NDA",
  "nonproprietary_name": "emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide",
  "start_marketing_date": "20160301",
  "active_numerator_strength": "200; 25; 25"
}

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