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United States · US · US:42385-928_27623aed-629d-4406-a0bf-4f234fc4e6c6

Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate

Orange BookUNIISPLATC J05AG

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

Identification

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

Packs · 2

  • ndc11
    4238592830
    30 TABLET, FILM COATED in 1 BOTTLE (42385-928-30)
  • ndc11
    4238592890
    90 TABLET, FILM COATED in 1 BOTTLE (42385-928-90)

Annotations

UNII (FDA Substance ID)
JE6H2O27P8
EFAVIRENZ
RxCUI 195085
Orange Book
A212786
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": "42385-928_27623aed-629d-4406-a0bf-4f234fc4e6c6",
  "productndc": "42385-928",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "212786",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "600MG;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": "ANDA212786",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate",
  "start_marketing_date": "20200514",
  "active_numerator_strength": "600; 300; 300"
}

Related drugs

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