Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate

{
  "unii": {
    "unii": "JE6H2O27P8",
    "rxcui": "195085",
    "inchikey": "XPOQHMRABVBWPR-ZDUSSCGKSA-N",
    "display_name": "EFAVIRENZ",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "ec61f069-632e-4628-b9b1-701d381a1a06": {
      "match": "brand_token",
      "title": "EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]",
      "spl_version": "100",
      "published_date": "2025-11-17"
    }
  },
  "productid": "42385-929_80228c3a-152e-4170-9469-b4e13b137bcb",
  "productndc": "42385-929",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "213038",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "400MG;300MG;300MG",
        "product_no": "001",
        "approval_date": "May 14, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE",
  "proprietary_name": "Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "ANDA213038",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate",
  "start_marketing_date": "20200514",
  "active_numerator_strength": "400; 300; 300"
}