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United States · US · US:0378-5440_d9a4185e-43fa-4aeb-9b0f-8db01b166038

Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate

Orange BookUNIISPLATC J05AF

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

Identification

ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeJ05AF
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0378544093
    30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5440-93)

Annotations

UNII (FDA Substance ID)
G70B4ETF4S
EMTRICITABINE
RxCUI 276237
Orange Book
A208452
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "G70B4ETF4S",
    "rxcui": "276237",
    "inchikey": "XQSPYNMVSIKCOC-NTSWFWBYSA-N",
    "display_name": "EMTRICITABINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "7193c90e-456c-4cfb-8181-65a1618dae51": {
      "match": "brand_token",
      "title": "EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [LAURUS LABS LIMITED]",
      "spl_version": "1",
      "published_date": "2026-03-06"
    }
  },
  "productid": "0378-5440_d9a4185e-43fa-4aeb-9b0f-8db01b166038",
  "productndc": "0378-5440",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "208452",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG;EQ 25MG BASE;300MG",
        "product_no": "001",
        "approval_date": "May 20, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE",
  "proprietary_name": "Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "ANDA208452",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate",
  "start_marketing_date": "20250527",
  "active_numerator_strength": "200; 25; 300"
}

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