MONISTAT 3

Orange BookSPL

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

Identification

ManufacturerInsight Pharmaceuticals LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6373601703
1 KIT in 1 PACKAGE, COMBINATION (63736-017-03) * 3 SUPPOSITORY in 1 BLISTER PACK * 9 g in 1 TUBE

Annotations

Orange Book

N020670

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd": {
      "match": "brand_token",
      "title": "MONISTAT 3 COMBINATION PACK 3 OVULE INSERTS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS LLC]",
      "spl_version": "5",
      "published_date": "2026-04-20"
    }
  },
  "productid": "63736-017_dd4127f7-4f74-41fa-b170-d28fe5639cf5",
  "productndc": "63736-017",
  "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": "MONISTAT 3",
  "active_ingred_unit": null,
  "application_number": "NDA020670",
  "marketing_category": "NDA",
  "nonproprietary_name": "Miconazole Nitrate",
  "start_marketing_date": "19960416",
  "active_numerator_strength": null
}

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