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United States · US · US:42385-801_7193c90e-456c-4cfb-8181-65a1618dae51

emtricitabine, rilpivirine and tenofovir disoproxil fumarate

Orange BookUNIISPLATC J05AF

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

Identification

ManufacturerLaurus Labs Limited
CountryUS (United States)
ATC codeJ05AF
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4238580130
    30 TABLET, FILM COATED in 1 BOTTLE (42385-801-30)

Annotations

UNII (FDA Substance ID)
G70B4ETF4S
EMTRICITABINE
RxCUI 276237
Orange Book
A220232
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": "42385-801_7193c90e-456c-4cfb-8181-65a1618dae51",
  "productndc": "42385-801",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "220232",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG;EQ 25MG BASE;300MG",
        "product_no": "001",
        "approval_date": "Mar 4, 2026"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE",
  "proprietary_name": "emtricitabine, rilpivirine and tenofovir disoproxil fumarate",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "ANDA220232",
  "marketing_category": "ANDA",
  "nonproprietary_name": "emtricitabine, rilpivirine and tenofovir disoproxil fumarate",
  "start_marketing_date": "20260305",
  "active_numerator_strength": "200; 25; 300"
}

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