VAGISTAT 3

Orange BookSPL

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

Identification

ManufacturerCombe Incorporated

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
1150900811
1 KIT in 1 CARTON (11509-0081-1) * 3 BLISTER PACK in 1 KIT / 1 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT / 9 g in 1 TUBE

Annotations

Orange Book

A075329

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "e15a28cd-9e64-4e9e-8df9-829d84f1816c": {
      "match": "brand_token",
      "title": "VAGISTAT 3 (MICONAZOLE NITRATE) KIT [COMBE INCORPORATED]",
      "spl_version": "6",
      "published_date": "2025-11-17"
    }
  },
  "productid": "11509-0081_9181ac4a-a921-4c23-a199-eb62910b33f5",
  "productndc": "11509-0081",
  "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": "VAGISTAT 3",
  "active_ingred_unit": null,
  "application_number": "ANDA075329",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Miconazole nitrate",
  "start_marketing_date": "20180327",
  "active_numerator_strength": null
}

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