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United States · US · US:68071-3544_2d3fbb35-987f-7d36-e063-6394a90a1acd

Miconazole 7

Orange BookUNIISPLATC G01AF04

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

Identification

ManufacturerNuCare Pharmaceuticals,Inc.
CountryUS (United States)
ATC codeG01AF04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6807135447
    1 TUBE, WITH APPLICATOR in 1 CARTON (68071-3544-7) / 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": "68071-3544_2d3fbb35-987f-7d36-e063-6394a90a1acd",
  "productndc": "68071-3544",
  "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": "20210315",
  "active_numerator_strength": "20"
}

Related drugs

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