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United States · US · US:72162-2565_b9bbd941-4d8b-434f-8c61-0a4fb2e9a989

Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate

Orange BookUNIISPLATC J05AG

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeJ05AG
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7216225653
    30 TABLET, FILM COATED in 1 BOTTLE (72162-2565-3)

Annotations

UNII (FDA Substance ID)
JE6H2O27P8
EFAVIRENZ
RxCUI 195085
Orange Book
A203041
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "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": "72162-2565_b9bbd941-4d8b-434f-8c61-0a4fb2e9a989",
  "productndc": "72162-2565",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "203041",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "600MG;200MG;300MG",
        "product_no": "001",
        "approval_date": "Sep 4, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE",
  "proprietary_name": "Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "ANDA203041",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate",
  "start_marketing_date": "20210330",
  "active_numerator_strength": "600; 200; 300"
}

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