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United States · US · US:0254-2045_15fdf050-71cb-476f-a7ce-38c40262f381

POSACONAZOLE

In shortageOrange BookUNIISPLATC J02AC04

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

Identification

ManufacturerENDO USA, Inc.
CountryUS (United States)
ATC codeJ02AC04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0254204502
    60 TABLET, COATED in 1 BOTTLE (0254-2045-02)

Annotations

UNII (FDA Substance ID)
6TK1G07BHZ
POSACONAZOLE
RxCUI 282446
Orange Book
N205053
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Posaconazole Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "6TK1G07BHZ",
    "rxcui": "282446",
    "inchikey": "RAGOYPUPXAKGKH-XAKZXMRKSA-N",
    "display_name": "POSACONAZOLE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "548124ce-8050-46a9-967b-ff23dfb18633": {
      "match": "brand_token",
      "title": "POSACONAZOLE TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]",
      "spl_version": "9",
      "published_date": "2026-05-26"
    }
  },
  "productid": "0254-2045_15fdf050-71cb-476f-a7ce-38c40262f381",
  "productndc": "0254-2045",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "205053",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Nov 25, 2013"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "POSACONAZOLE",
  "shortage_reason": "Posaconazole Injection",
  "shortage_status": "current",
  "proprietary_name": "POSACONAZOLE",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA205053",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "posaconazole",
  "start_marketing_date": "20190830",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code J02AC04.

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