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United States · US · US:71205-776_26719f78-0a87-4928-ab9f-7bb4665ba7c2

Emtricitabine and Tenofovir Disoproxil Fumarate

Orange BookUNIISPLATC J05AF

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeJ05AF
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    7120577603
    3 TABLET, FILM COATED in 1 BOTTLE (71205-776-03)
  • ndc11
    7120577607
    7 TABLET, FILM COATED in 1 BOTTLE (71205-776-07)
  • ndc11
    7120577630
    30 TABLET, FILM COATED in 1 BOTTLE (71205-776-30)
  • ndc11
    7120577660
    60 TABLET, FILM COATED in 1 BOTTLE (71205-776-60)
  • ndc11
    7120577690
    90 TABLET, FILM COATED in 1 BOTTLE (71205-776-90)

Annotations

UNII (FDA Substance ID)
G70B4ETF4S
EMTRICITABINE
RxCUI 276237
Orange Book
A090513
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": "71205-776_26719f78-0a87-4928-ab9f-7bb4665ba7c2",
  "productndc": "71205-776",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "090513",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG;300MG",
        "product_no": "001",
        "approval_date": "Jan 26, 2018"
      }
    ],
    "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": "ANDA090513",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Emtricitabine and Tenofovir Disoproxil Fumarate",
  "start_marketing_date": "20210330",
  "active_numerator_strength": "200; 300"
}

Related drugs

Other records sharing ATC code J05AF.

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