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United States · US · US:61958-1101_21d7850d-11ea-43cc-84a5-0dae02a19ce6

COMPLERA

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
    6195811011
    30 TABLET, FILM COATED in 1 BOTTLE (61958-1101-1)

Annotations

UNII (FDA Substance ID)
G70B4ETF4S
EMTRICITABINE
RxCUI 276237
Orange Book
N202123
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": {
    "d637cfab-f1e8-4eb3-a1b3-f85ca3bec612": {
      "match": "brand_token",
      "title": "COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]",
      "spl_version": "21",
      "published_date": "2025-07-25"
    }
  },
  "productid": "61958-1101_21d7850d-11ea-43cc-84a5-0dae02a19ce6",
  "productndc": "61958-1101",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "202123",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "200MG;EQ 25MG BASE;300MG",
        "product_no": "001",
        "approval_date": "Aug 10, 2011"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE",
  "proprietary_name": "COMPLERA",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "NDA202123",
  "marketing_category": "NDA",
  "nonproprietary_name": "emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate",
  "start_marketing_date": "20110810",
  "active_numerator_strength": "200; 25; 300"
}

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