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United States · US · US:73159-004_28e14b24-611e-9c6f-e063-6294a90ac043

Ertaczo

Orange BookUNIISPLATC D01AC14

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

Identification

ManufacturerLacer Pharma, LLC
CountryUS (United States)
ATC codeD01AC14
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7315900460
    1 TUBE in 1 CARTON (73159-004-60) / 60 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
1DV05410M5
SERTACONAZOLE NITRATE
RxCUI 236601
Orange Book
N021385
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "1DV05410M5",
    "rxcui": "236601",
    "inchikey": "HAAITRDZHUANGT-UHFFFAOYSA-N",
    "display_name": "SERTACONAZOLE NITRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "c6fa8dc4-2620-474e-a9b4-6657d9cbfa96": {
      "match": "brand_token",
      "title": "ERTACZO (SERTACONAZOLE NITRATE) CREAM [CORAL WAY PHARMA, LLC]",
      "spl_version": "2",
      "published_date": "2026-04-09"
    }
  },
  "productid": "73159-004_28e14b24-611e-9c6f-e063-6294a90ac043",
  "productndc": "73159-004",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "021385",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2%",
        "product_no": "001",
        "approval_date": "Dec 10, 2003"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SERTACONAZOLE NITRATE",
  "proprietary_name": "Ertaczo",
  "active_ingred_unit": "mg/g",
  "application_number": "NDA021385",
  "marketing_category": "NDA",
  "nonproprietary_name": "Sertaconazole Nitrate",
  "start_marketing_date": "20241126",
  "active_numerator_strength": "20"
}

Related drugs

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