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United States · US · US:72611-716_04d9a64e-d4e5-22d2-bfef-32594ee380d2

Dexrazoxane

Orange BookUNIISPLATC V03AF02

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

Identification

ManufacturerAlmaject, Inc.
CountryUS (United States)
ATC codeV03AF02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7261171672
    1 VIAL, SINGLE-DOSE in 1 CARTON (72611-716-72) / 50 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
5346058Q7S
DEXRAZOXANE HYDROCHLORIDE
RxCUI 1294534
Orange Book
A207321
APAP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "5346058Q7S",
    "rxcui": "1294534",
    "inchikey": "BIFMNMPSIYHKDN-FJXQXJEOSA-N",
    "display_name": "DEXRAZOXANE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "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": "72611-716_04d9a64e-d4e5-22d2-bfef-32594ee380d2",
  "productndc": "72611-716",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "207321",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 500MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Nov 28, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 250MG BASE/VIAL",
        "product_no": "002",
        "approval_date": "Dec 16, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXRAZOXANE HYDROCHLORIDE",
  "proprietary_name": "Dexrazoxane",
  "active_ingred_unit": "mg/50mL",
  "application_number": "ANDA207321",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dexrazoxane for Injection",
  "start_marketing_date": "20220601",
  "active_numerator_strength": "500"
}

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