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United States · US · US:50090-7719_09d2278c-577b-400f-a781-7be3f5b07834

Emtricitabine and tenofovir disoproxil fumarate

Orange BookUNIISPLATC J05AF

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeJ05AF
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009077191
    30 TABLET, FILM COATED in 1 BOTTLE (50090-7719-1)

Annotations

UNII (FDA Substance ID)
G70B4ETF4S
EMTRICITABINE
RxCUI 276237
Orange Book
A201806
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": {
    "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": "50090-7719_09d2278c-577b-400f-a781-7be3f5b07834",
  "productndc": "50090-7719",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "201806",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG;300MG",
        "product_no": "001",
        "approval_date": "Oct 7, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG;150MG",
        "product_no": "002",
        "approval_date": "Mar 3, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "133MG;200MG",
        "product_no": "003",
        "approval_date": "Mar 3, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "167MG;250MG",
        "product_no": "004",
        "approval_date": "Mar 3, 2025"
      }
    ],
    "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": "ANDA201806",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Emtricitabine and tenofovir disoproxil fumarate",
  "start_marketing_date": "20211007",
  "active_numerator_strength": "200; 300"
}

Related drugs

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