Monistat 3 Combination Pack

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
6373601001
1 KIT in 1 PACKAGE, COMBINATION (63736-010-01) * 5 g in 1 APPLICATOR * 9 g in 1 TUBE

Annotations

Orange Book

N021261

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": "63736-010_03108766-1001-4aac-9dd8-799a63662a25",
  "productndc": "63736-010",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "021261",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2%,4%",
        "product_no": "001",
        "approval_date": "Feb 2, 2001"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "2%,4%",
        "product_no": "003",
        "approval_date": "Jun 17, 2003"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": null,
  "proprietary_name": "Monistat 3 Combination Pack",
  "active_ingred_unit": null,
  "application_number": "NDA021261",
  "marketing_category": "NDA",
  "nonproprietary_name": "Miconazole Nitrate",
  "start_marketing_date": "20091210",
  "active_numerator_strength": null
}

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