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United States · US · US:64380-719_bf6c27ef-5fde-4c9f-82b2-fbf0797bd359

Emtricitabine and Tenofovir Disoproxil Fumarate

Orange BookUNIISPLATC J05AF

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

Identification

ManufacturerStrides Pharma Science Limited
CountryUS (United States)
ATC codeJ05AF
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6438071904
    30 TABLET in 1 BOTTLE, PLASTIC (64380-719-04)

Annotations

UNII (FDA Substance ID)
G70B4ETF4S
EMTRICITABINE
RxCUI 276237
Orange Book
A091055
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": {
    "4feb83a5-9142-0c67-e063-6394a90a710f": {
      "match": "brand_token",
      "title": "EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.]",
      "spl_version": "1",
      "published_date": "2026-04-22"
    }
  },
  "productid": "64380-719_bf6c27ef-5fde-4c9f-82b2-fbf0797bd359",
  "productndc": "64380-719",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "091055",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG;300MG",
        "product_no": "001",
        "approval_date": "Jan 13, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE",
  "proprietary_name": "Emtricitabine and Tenofovir Disoproxil Fumarate",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA091055",
  "marketing_category": "ANDA",
  "nonproprietary_name": "EMTRICITABINE and TENOFOVIR Disoproxil Fumarate",
  "start_marketing_date": "20210330",
  "active_numerator_strength": "200; 300"
}

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