NOXAFIL

In shortageOrange BookUNIISPLATC J02AC04

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

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
0085132801
1 BOTTLE, GLASS in 1 CARTON (0085-1328-01) / 105 mL in 1 BOTTLE, GLASS

Annotations

UNII (FDA Substance ID)

6TK1G07BHZ

POSACONAZOLE

RxCUI 282446

Orange Book

N022003

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": "0085-1328_56740f7d-3b29-4786-b5c7-eea6c0f14400",
  "productndc": "0085-1328",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "022003",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "40MG/ML",
        "product_no": "001",
        "approval_date": "Sep 15, 2006"
      }
    ],
    "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/mL",
  "application_number": "NDA022003",
  "marketing_category": "NDA",
  "nonproprietary_name": "posaconazole",
  "start_marketing_date": "20060915",
  "active_numerator_strength": "40"
}

Related drugs

Other records sharing ATC code J02AC04.

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