miconazole 1

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerMeijer Distribution Inc

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4125019900
1 KIT in 1 CARTON (41250-199-00) * 1 SUPPOSITORY in 1 POUCH * 9 g in 1 TUBE

Annotations

Orange Book

A079114

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "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": "41250-199_a1402e67-6674-4ba0-95c4-818153ce429a",
  "productndc": "41250-199",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "079114",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2%,1.2GM",
        "product_no": "001",
        "approval_date": "Jun 2, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": null,
  "proprietary_name": "miconazole 1",
  "active_ingred_unit": null,
  "application_number": "ANDA079114",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Miconazole nitrate",
  "start_marketing_date": "20100611",
  "active_numerator_strength": null
}

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