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United States · US · US:0363-2070_083e194f-b107-45e6-b95d-25ae191cccb6

miconazole 3

Orange BookUNIISPLATC G01AF04

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

Identification

ManufacturerWalgreen Company
CountryUS (United States)
ATC codeG01AF04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0363207014
    3 APPLICATOR in 1 CARTON (0363-2070-14) / 5 g in 1 APPLICATOR

Annotations

UNII (FDA Substance ID)
VW4H1CYW1K
MICONAZOLE NITRATE
RxCUI 42790
Orange Book
A091366
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "VW4H1CYW1K",
    "rxcui": "42790",
    "inchikey": "MCCACAIVAXEFAL-UHFFFAOYSA-N",
    "display_name": "MICONAZOLE NITRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "VAGINAL",
  "spl_meta": {
    "2f19d76f-1348-483e-8720-612d30928bb5": {
      "match": "brand_token",
      "title": "MICONAZOLE 7 (MICONAZOLE NITRATE) CREAM [SAFEWAY]",
      "spl_version": "2",
      "published_date": "2026-05-28"
    }
  },
  "productid": "0363-2070_083e194f-b107-45e6-b95d-25ae191cccb6",
  "productndc": "0363-2070",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "091366",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "4%",
        "product_no": "001",
        "approval_date": "Jan 15, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "MICONAZOLE NITRATE",
  "proprietary_name": "miconazole 3",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA091366",
  "marketing_category": "ANDA",
  "nonproprietary_name": "miconazole nitrate",
  "start_marketing_date": "20180615",
  "active_numerator_strength": "40"
}

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