CRESEMBA

Orange BookUNIISPL

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

Identification

ManufacturerAstellas Pharma US, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0469286035
7 BLISTER PACK in 1 CARTON (0469-2860-35) / 5 CAPSULE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

31Q44514JV

ISAVUCONAZONIUM SULFATE

RxCUI 1608321

Orange Book

N207500

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "31Q44514JV",
    "rxcui": "1608321",
    "inchikey": "LWXUIUUOMSMZKJ-KLFWAVJMSA-M",
    "display_name": "ISAVUCONAZONIUM SULFATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "8f7f73b8-586a-4df0-935f-fecd4696c16c": {
      "match": "brand_token",
      "title": "CRESEMBA (ISAVUCONAZONIUM SULFATE) CAPSULE CRESEMBA (ISAVUCONAZONIUM SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ASTELLAS PHARMA US, INC.]",
      "spl_version": "21",
      "published_date": "2025-05-05"
    }
  },
  "productid": "0469-2860_7e6e45d4-9266-4451-b6b6-0d054bbcab63",
  "productndc": "0469-2860",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "207500",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "186MG",
        "product_no": "001",
        "approval_date": "Mar 6, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "74.5MG",
        "product_no": "002",
        "approval_date": "Nov 22, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ISAVUCONAZONIUM SULFATE",
  "proprietary_name": "CRESEMBA",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA207500",
  "marketing_category": "NDA",
  "nonproprietary_name": "isavuconazonium sulfate",
  "start_marketing_date": "20221122",
  "active_numerator_strength": "40"
}

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