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United States · US · US:42385-915_590152fa-ff7a-4db5-8e11-394c6b44c3c0

Efavirenz, emtricitabine 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
    4238591530
    30 TABLET, FILM COATED in 1 BOTTLE (42385-915-30)
  • ndc11
    4238591590
    90 TABLET, FILM COATED in 1 BOTTLE (42385-915-90)

Annotations

UNII (FDA Substance ID)
JE6H2O27P8
EFAVIRENZ
RxCUI 195085
Orange Book
A213541
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": "42385-915_590152fa-ff7a-4db5-8e11-394c6b44c3c0",
  "productndc": "42385-915",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "213541",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "600MG;200MG;300MG",
        "product_no": "001",
        "approval_date": "Dec 22, 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": "ANDA213541",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Efavirenz, emtricitabine and tenofovir disoproxil fumarate",
  "start_marketing_date": "20211222",
  "active_numerator_strength": "600; 200; 300"
}

Related drugs

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