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United States · US · US:0363-5203_d536a071-d970-4dca-86d0-669dcc421ae6

Miconazole 3

Orange BookSPL

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

Identification

ManufacturerWALGREEN COMPANY
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0363520301
    1 KIT in 1 PACKAGE, COMBINATION (0363-5203-01) * 1 APPLICATOR in 1 PACKAGE / 1 SUPPOSITORY in 1 APPLICATOR * 9 g in 1 TUBE

Annotations

Orange Book
N020670
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "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": "0363-5203_d536a071-d970-4dca-86d0-669dcc421ae6",
  "productndc": "0363-5203",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "020670",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2%,200MG",
        "product_no": "002",
        "approval_date": "Apr 16, 1996"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": null,
  "proprietary_name": "Miconazole 3",
  "active_ingred_unit": null,
  "application_number": "NDA020670",
  "marketing_category": "NDA",
  "nonproprietary_name": "Miconazole nitrate",
  "start_marketing_date": "20160418",
  "active_numerator_strength": null
}

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