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United States · US · US:0085-4324_56740f7d-3b29-4786-b5c7-eea6c0f14400

NOXAFIL

In shortageOrange BookUNIISPLATC J02AC04

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

Identification

ManufacturerMerck Sharp & Dohme LLC
CountryUS (United States)
ATC codeJ02AC04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0085432402
    60 TABLET, COATED in 1 BOTTLE (0085-4324-02)

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": {
    "b073b082-7b57-4423-8c06-4fd4263d6f84": {
      "match": "brand_token",
      "title": "NOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION NOXAFIL (POSACONAZOLE) POWDER, FOR SUSPENSION [MERCK SHARP & DOHME LLC]",
      "spl_version": "56",
      "published_date": "2026-03-06"
    }
  },
  "productid": "0085-4324_56740f7d-3b29-4786-b5c7-eea6c0f14400",
  "productndc": "0085-4324",
  "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        "strength": "100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",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": "NOXAFIL",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA205053",
  "marketing_category": "NDA",
  "nonproprietary_name": "posaconazole",
  "start_marketing_date": "20131125",
  "active_numerator_strength": "100"
}

Related drugs

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