ISTODAX

Orange Book

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

Identification

ManufacturerCelgene Corporation

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5957298401
1 KIT in 1 CARTON (59572-984-01) * 2.2 mL in 1 VIAL, GLASS (59572-962-10) * 2.4 mL in 1 VIAL, GLASS (59572-973-02)

Annotations

Orange Book

N022393

Raw payload (JSON)

{
  "route": null,
  "productid": "59572-984_08c46856-2700-4885-ba5d-dced9d8056e1",
  "productndc": "59572-984",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "022393",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "10MG/VIAL",
        "product_no": "001",
        "approval_date": "Nov 5, 2009"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "ISTODAX",
  "active_ingred_unit": null,
  "application_number": "NDA022393",
  "marketing_category": "NDA",
  "nonproprietary_name": "romidepsin",
  "start_marketing_date": "20100104",
  "active_numerator_strength": null
}

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