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United States · US · US:37808-928_6b7d09f4-b857-4e61-9541-2a143bd5a8ee

Miconazole

Orange BookUNIISPLATC G01AF04

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

Identification

ManufacturerH E B
CountryUS (United States)
ATC codeG01AF04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    3780892814
    1 TUBE in 1 CARTON (37808-928-14) / 5 g in 1 TUBE

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": "37808-928_6b7d09f4-b857-4e61-9541-2a143bd5a8ee",
  "productndc": "37808-928",
  "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",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA091366",
  "marketing_category": "ANDA",
  "nonproprietary_name": "miconazole nitrate",
  "start_marketing_date": "20200317",
  "active_numerator_strength": "40"
}

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