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United States · US · US:51316-689_e55b2ee9-0e90-4788-88b1-ff25dc81b1ce

Miconazole 3

Orange BookSPL

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

Identification

ManufacturerCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5131668900
    1 KIT in 1 CARTON (51316-689-00) * 3 BLISTER PACK in 1 KIT (0113-6650-00) / 1 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT (0113-8123-00) / 9 g in 1 TUBE

Annotations

Orange Book
A075329
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": "51316-689_e55b2ee9-0e90-4788-88b1-ff25dc81b1ce",
  "productndc": "51316-689",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "075329",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2%,200MG",
        "product_no": "001",
        "approval_date": "Apr 20, 1999"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": null,
  "proprietary_name": "Miconazole 3",
  "active_ingred_unit": null,
  "application_number": "ANDA075329",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Miconazole nitrate",
  "start_marketing_date": "20240417",
  "active_numerator_strength": null
}

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