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United States · US · US:61958-0704_32422ee8-1cdc-4305-bb3e-0458472513fc

Truvada

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
    6195807041
    30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0704-1)

Annotations

UNII (FDA Substance ID)
G70B4ETF4S
EMTRICITABINE
RxCUI 276237
Orange Book
N021752
ABABABAB
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": {
    "54e82b13-a037-49ed-b4b3-030b37c0ecdd": {
      "match": "brand_token",
      "title": "TRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC]",
      "spl_version": "32",
      "published_date": "2025-07-25"
    }
  },
  "productid": "61958-0704_32422ee8-1cdc-4305-bb3e-0458472513fc",
  "productndc": "61958-0704",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "021752",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "200MG;300MG",
        "product_no": "001",
        "approval_date": "Aug 2, 2004"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "100MG;150MG",
        "product_no": "002",
        "approval_date": "Mar 10, 2016"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "133MG;200MG",
        "product_no": "003",
        "approval_date": "Mar 10, 2016"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "167MG;250MG",
        "product_no": "004",
        "approval_date": "Mar 10, 2016"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE",
  "proprietary_name": "Truvada",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA021752",
  "marketing_category": "NDA",
  "nonproprietary_name": "emtricitabine and tenofovir disoproxil fumarate",
  "start_marketing_date": "20160310",
  "active_numerator_strength": "133; 200"
}

Related drugs

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