ERAXIS

Orange BookUNIISPLATC J02AX06

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

Identification

ManufacturerRoerig

CountryUS (United States)

ATC codeJ02AX06

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0049011628
30 mL in 1 VIAL, SINGLE-USE (0049-0116-28)

Annotations

UNII (FDA Substance ID)

9HLM53094I

ANIDULAFUNGIN

RxCUI 341018

Orange Book

N021632

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "9HLM53094I",
    "rxcui": "341018",
    "inchikey": "JHVAMHSQVVQIOT-MFAJLEFUSA-N",
    "display_name": "ANIDULAFUNGIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "a88d9010-55fb-4a02-baff-042cd27688ea": {
      "match": "brand_token",
      "title": "ERAXIS (ANIDULAFUNGIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ROERIG]",
      "spl_version": "24",
      "published_date": "2025-08-25"
    }
  },
  "productid": "0049-0116_f59883f3-edec-4246-a236-790cc492fdb9",
  "productndc": "0049-0116",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "021632",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "50MG/VIAL",
        "product_no": "001",
        "approval_date": "Feb 17, 2006"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "100MG/VIAL",
        "product_no": "002",
        "approval_date": "Nov 14, 2006"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ANIDULAFUNGIN",
  "proprietary_name": "ERAXIS",
  "active_ingred_unit": "mg/30mL",
  "application_number": "NDA021632",
  "marketing_category": "NDA",
  "nonproprietary_name": "anidulafungin",
  "start_marketing_date": "20060217",
  "active_numerator_strength": "100"
}

Related drugs

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