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United States · US · US:59137-335_2d06b03c-17aa-0492-e063-6294a90abd8f

GRAFAPEX

Orange BookUNIISPLATC L01AB02

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

Identification

ManufacturerMedexus Pharma, Inc.
CountryUS (United States)
ATC codeL01AB02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5913733501
    1 VIAL in 1 CARTON (59137-335-01) / 1 g in 1 VIAL

Annotations

UNII (FDA Substance ID)
CO61ER3EPI
TREOSULFAN
RxCUI 38508
Orange Book
N214759
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "CO61ER3EPI",
    "rxcui": "38508",
    "inchikey": "YCPOZVAOBBQLRI-WDSKDSINSA-N",
    "display_name": "TREOSULFAN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "2d06b03c-17aa-0492-e063-6294a90abd8f": {
      "match": "brand_token",
      "title": "GRAFAPEX (TREOSULFAN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEDEXUS PHARMA, INC.]",
      "spl_version": "1",
      "published_date": "2025-02-03"
    }
  },
  "productid": "59137-335_2d06b03c-17aa-0492-e063-6294a90abd8f",
  "productndc": "59137-335",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "214759",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1GM/VIAL",
        "product_no": "001",
        "approval_date": "Jan 21, 2025"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "5GM/VIAL",
        "product_no": "002",
        "approval_date": "Jan 21, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TREOSULFAN",
  "proprietary_name": "GRAFAPEX",
  "active_ingred_unit": "mg/g",
  "application_number": "NDA214759",
  "marketing_category": "NDA",
  "nonproprietary_name": "treosulfan",
  "start_marketing_date": "20250128",
  "active_numerator_strength": "1000"
}

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