miconazole 1

Orange BookSPL

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

Identification

ManufacturerH E B

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
3780819900
1 KIT in 1 CARTON (37808-199-00) * 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": "37808-199_a4b8e7c8-3d3e-4560-bf58-3acfe1266790",
  "productndc": "37808-199",
  "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": "20100607",
  "active_numerator_strength": null
}

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