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United States · US · US:0378-1640_4648d2c0-408b-4d93-99a1-627b428a89cf

Voriconazole

In shortageOrange BookUNIISPLATC J02AC03

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

Identification

ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeJ02AC03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0378164093
    30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1640-93)

Annotations

UNII (FDA Substance ID)
JFU09I87TR
VORICONAZOLE
RxCUI 121243
Orange Book
A090547
ABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Voriconazole Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "JFU09I87TR",
    "rxcui": "121243",
    "inchikey": "BCEHBSKCWLPMDN-MGPLVRAMSA-N",
    "display_name": "VORICONAZOLE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "23f25c6b-f075-42dc-ae05-63b5bf410929": {
      "match": "brand_token",
      "title": "VORICONAZOLE TABLET, FILM COATED [SAFECOR HEALTH LLC]",
      "spl_version": "3",
      "published_date": "2026-06-01"
    }
  },
  "productid": "0378-1640_4648d2c0-408b-4d93-99a1-627b428a89cf",
  "productndc": "0378-1640",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "090547",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Apr 22, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Apr 22, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VORICONAZOLE",
  "shortage_reason": "Voriconazole Injection",
  "shortage_status": "current",
  "proprietary_name": "Voriconazole",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090547",
  "marketing_category": "ANDA",
  "nonproprietary_name": "voriconazole",
  "start_marketing_date": "20110215",
  "active_numerator_strength": "200"
}

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