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United States · US · US:33342-138_3b244bb3-2e8b-4fde-b69d-330aca56fb8e

Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate

Orange BookUNIISPLATC J05AG

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

Identification

ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC codeJ05AG
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    3334213807
    30 TABLET, FILM COATED in 1 BOTTLE (33342-138-07)

Annotations

UNII (FDA Substance ID)
JE6H2O27P8
EFAVIRENZ
RxCUI 195085
Orange Book
A204287
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": "33342-138_3b244bb3-2e8b-4fde-b69d-330aca56fb8e",
  "productndc": "33342-138",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "204287",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "600MG;200MG;300MG",
        "product_no": "001",
        "approval_date": "Sep 13, 2021"
      }
    ],
    "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": "ANDA204287",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate",
  "start_marketing_date": "20210913",
  "active_numerator_strength": "600; 200; 300"
}

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