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United States · US · US:59726-988_e318656a-0f0d-4a15-bc63-23ebd8f58ea1

Miconazole 7

Orange BookUNIISPLATC G01AF04

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

Identification

ManufacturerP & L Development, LLC
CountryUS (United States)
ATC codeG01AF04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5972698801
    1 TUBE, WITH APPLICATOR in 1 CARTON (59726-988-01) / 45 g in 1 TUBE, WITH APPLICATOR

Annotations

UNII (FDA Substance ID)
VW4H1CYW1K
MICONAZOLE NITRATE
RxCUI 42790
Orange Book
A074164
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": "59726-988_e318656a-0f0d-4a15-bc63-23ebd8f58ea1",
  "productndc": "59726-988",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "074164",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2%",
        "product_no": "001",
        "approval_date": "Mar 29, 1996"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "MICONAZOLE NITRATE",
  "proprietary_name": "Miconazole 7",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA074164",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Miconazole Nitrate",
  "start_marketing_date": "20210528",
  "active_numerator_strength": "20"
}

Related drugs

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