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United States · US · US:0078-0937_59dff6dc-c0b0-4f26-9738-32f8a6540033

EGATEN

Orange BookUNIISPLATC P02BX04

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

Identification

ManufacturerNovartis Pharmaceuticals Corporation
CountryUS (United States)
ATC codeP02BX04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0078093791
    4 TABLET in 1 BLISTER PACK (0078-0937-91)

Annotations

UNII (FDA Substance ID)
4784C8E03O
TRICLABENDAZOLE
RxCUI 2118525
Orange Book
N208711
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "4784C8E03O",
    "rxcui": "2118525",
    "inchikey": "NQPDXQQQCQDHHW-UHFFFAOYSA-N",
    "display_name": "TRICLABENDAZOLE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "5552884e-10ea-450c-9658-d3d4f33c946e": {
      "match": "brand_token",
      "title": "EGATEN (TRICLABENDAZOLE) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]",
      "spl_version": "11",
      "published_date": "2025-03-10"
    }
  },
  "productid": "0078-0937_59dff6dc-c0b0-4f26-9738-32f8a6540033",
  "productndc": "0078-0937",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "208711",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Feb 13, 2019"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TRICLABENDAZOLE",
  "proprietary_name": "EGATEN",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA208711",
  "marketing_category": "NDA",
  "nonproprietary_name": "triclabendazole",
  "start_marketing_date": "20190213",
  "active_numerator_strength": "250"
}

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