Emtricitabine and Tenofovir Disoproxil Fumarate

Orange BookUNIISPLATC J05AF

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerMajor Pharmaceuticals

CountryUS (United States)

ATC codeJ05AF

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0904717207
30 BLISTER PACK in 1 CARTON (0904-7172-07) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

G70B4ETF4S

EMTRICITABINE

RxCUI 276237

Orange Book

A212114

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": "0904-7172_e3e2c3b9-806a-4639-ab44-5c5b4bb1166e",
  "productndc": "0904-7172",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "212114",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG;300MG",
        "product_no": "001",
        "approval_date": "Jul 26, 2019"
      }
    ],
    "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": "ANDA212114",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Emtricitabine and Tenofovir Disoproxil Fumarate",
  "start_marketing_date": "20190726",
  "active_numerator_strength": "200; 300"
}

Related drugs

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