Voriconazole

In shortageOrange BookUNIISPLATC J02AC03

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

Identification

ManufacturerMylan Institutional Inc.

CountryUS (United States)

ATC codeJ02AC03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5107916403
30 BLISTER PACK in 1 CARTON (51079-164-03) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-164-01)

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": "51079-164_3a879fbf-a5ce-949d-e063-6394a90a90d5",
  "productndc": "51079-164",
  "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": "20110808",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code J02AC03.

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