DEXRAZOXANE

Orange BookSPL

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

Identification

ManufacturerEugia US LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5515043401
1 KIT in 1 PACKAGE (55150-434-01) * 25 mL in 1 VIAL, SINGLE-DOSE (55150-432-01) * 25 mL in 1 VIAL (55150-433-01)

Annotations

Orange Book

A200752

APAP

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "9cbd2987-10bb-eceb-153d-ee7be1ed0c84": {
      "match": "brand_token",
      "title": "DEXRAZOXANE (DEXRAZOXANE FOR INJECTION) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ALMAJECT, INC.]",
      "spl_version": "4",
      "published_date": "2025-12-16"
    }
  },
  "productid": "55150-434_f0a2a9ff-2f1f-481b-96c8-404e9d4a60fa",
  "productndc": "55150-434",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "200752",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 250MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Oct 19, 2011"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 500MG BASE/VIAL",
        "product_no": "002",
        "approval_date": "Oct 19, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "DEXRAZOXANE",
  "active_ingred_unit": null,
  "application_number": "ANDA200752",
  "marketing_category": "ANDA",
  "nonproprietary_name": "DEXRAZOXANE",
  "start_marketing_date": "20160512",
  "active_numerator_strength": null
}

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