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United States · US · US:43386-089_56ca1aed-0ee1-4afa-8bc3-a6d5f503ba6e

voriconazole

In shortageOrange BookUNIISPLATC J02AC03

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

Identification

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

Packs · 1

  • ndc11
    4338608903
    30 TABLET, FILM COATED in 1 BOTTLE (43386-089-03)

Annotations

UNII (FDA Substance ID)
JFU09I87TR
VORICONAZOLE
RxCUI 121243
Orange Book
A207371
ABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Voriconazole Tablet
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": "43386-089_56ca1aed-0ee1-4afa-8bc3-a6d5f503ba6e",
  "productndc": "43386-089",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "207371",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "May 24, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "May 24, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VORICONAZOLE",
  "shortage_reason": "Voriconazole Tablet",
  "shortage_status": "current",
  "proprietary_name": "voriconazole",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA207371",
  "marketing_category": "ANDA",
  "nonproprietary_name": "voriconazole",
  "start_marketing_date": "20160524",
  "active_numerator_strength": "200"
}

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