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United States · US · US:0378-8222_1b5de1cf-d19f-424b-86c0-e2ebcb0b3cf0

VUSION

Orange BookUNIISPLATC A01AB

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

Identification

ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeA01AB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0378822250
    1 TUBE in 1 CARTON (0378-8222-50) / 50 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
VW4H1CYW1K
MICONAZOLE NITRATE
RxCUI 42790
Orange Book
N021026
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "VW4H1CYW1K",
    "rxcui": "42790",
    "inchikey": "MCCACAIVAXEFAL-UHFFFAOYSA-N",
    "display_name": "MICONAZOLE NITRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "b44b452d-3630-4cb5-8ed1-1f8edac4690c": {
      "match": "brand_token",
      "title": "VUSION (MICONAZOLE NITRATE, ZINC OXIDE, WHITE PETROLATUM) OINTMENT [MYLAN PHARMACEUTICALS INC.]",
      "spl_version": "6",
      "published_date": "2026-03-09"
    }
  },
  "productid": "0378-8222_1b5de1cf-d19f-424b-86c0-e2ebcb0b3cf0",
  "productndc": "0378-8222",
  "dosage_form": "OINTMENT",
  "orange_book": {
    "appl_no": "021026",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.25%;81.35%;15%",
        "product_no": "001",
        "approval_date": "Feb 16, 2006"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MICONAZOLE NITRATE; PETROLATUM; ZINC OXIDE",
  "proprietary_name": "VUSION",
  "active_ingred_unit": "mg/g; mg/g; mg/g",
  "application_number": "NDA021026",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "miconazole nitrate, zinc oxide, white petrolatum",
  "start_marketing_date": "20181106",
  "active_numerator_strength": "2.5; 813.5; 150"
}

Related drugs

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