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United States · US · US:63323-926_44fb8ff4-ec3d-4dcf-8e8c-207545d938a3

Romidepsin

Orange BookSPL

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

Identification

ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6332392688
    1 KIT in 1 CARTON (63323-926-88) * 2 mL in 1 VIAL, SINGLE-DOSE (63323-925-17) * 2.2 mL in 1 VIAL, SINGLE-DOSE (63323-922-03)

Annotations

Orange Book
A206254
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "73a2028d-6735-4cd4-b63d-d072df9927a1": {
      "match": "brand_token",
      "title": "ROMIDEPSIN KIT [FRESENIUS KABI USA, LLC]",
      "spl_version": "9",
      "published_date": "2026-05-28"
    }
  },
  "productid": "63323-926_44fb8ff4-ec3d-4dcf-8e8c-207545d938a3",
  "productndc": "63323-926",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "206254",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "10MG/VIAL",
        "product_no": "001",
        "approval_date": "Oct 12, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Romidepsin",
  "active_ingred_unit": null,
  "application_number": "ANDA206254",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Romidepsin",
  "start_marketing_date": "20211012",
  "active_numerator_strength": null
}

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