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United States · US · US:81811-100_0bb5d729-5109-e387-e063-6394a90a1fce

Ecoza

Orange BookUNIISPLATC D01AC03

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

Identification

ManufacturerResilia Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeD01AC03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8181110070
    1 CANISTER in 1 CARTON (81811-100-70) / 70 g in 1 CANISTER

Annotations

UNII (FDA Substance ID)
H438WYN10E
ECONAZOLE NITRATE
RxCUI 142434
Orange Book
N205175
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "H438WYN10E",
    "rxcui": "142434",
    "inchikey": "DDXORDQKGIZAME-UHFFFAOYSA-N",
    "display_name": "ECONAZOLE NITRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "0bb5fa27-32ed-ed13-e063-6394a90a1577": {
      "match": "brand_token",
      "title": "ECOZA (ECONAZOLE NITRATE) AEROSOL, FOAM [RESILIA PHARMACEUTICALS, INC.]",
      "spl_version": "1",
      "published_date": "2023-12-19"
    }
  },
  "productid": "81811-100_0bb5d729-5109-e387-e063-6394a90a1fce",
  "productndc": "81811-100",
  "dosage_form": "AEROSOL, FOAM",
  "orange_book": {
    "appl_no": "205175",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1%",
        "product_no": "001",
        "approval_date": "Oct 24, 2013"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ECONAZOLE NITRATE",
  "proprietary_name": "Ecoza",
  "active_ingred_unit": "mg/g",
  "application_number": "NDA205175",
  "marketing_category": "NDA",
  "nonproprietary_name": "econazole nitrate",
  "start_marketing_date": "20231204",
  "active_numerator_strength": "10"
}

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