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United States · US · US:72189-403_2c4cdf7a-45da-784b-e063-6294a90a82b9

Emtricitabine/TDF

Orange BookUNIISPLATC J05AF

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

Identification

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

Packs · 1

  • ndc11
    7218940303
    3 TABLET, FILM COATED in 1 BOTTLE (72189-403-03)

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": {
    "ef1a90ca-92bc-3787-e053-2a95a90a58ec": {
      "match": "brand_token",
      "title": "EMTRICITABINE/TDF TABLET, FILM COATED [DIRECT_RX]",
      "spl_version": "4",
      "published_date": "2025-01-23"
    }
  },
  "productid": "72189-403_2c4cdf7a-45da-784b-e063-6294a90a82b9",
  "productndc": "72189-403",
  "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/TDF",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA090513",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Emtricitabine/TDF",
  "start_marketing_date": "20221205",
  "active_numerator_strength": "200; 300"
}

Related drugs

Other records sharing ATC code J05AF.

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