Back to search
🇺🇸

United States · US · US:68083-388_31a8c608-3ad6-44fe-aec8-621a8b991677

Dexrazoxane

Orange BookUNIISPLATC V03AF02

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

Identification

ManufacturerGland Pharma Limited
CountryUS (United States)
ATC codeV03AF02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6808338801
    1 VIAL in 1 CARTON (68083-388-01) / 25 mL in 1 VIAL

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": "68083-388_31a8c608-3ad6-44fe-aec8-621a8b991677",
  "productndc": "68083-388",
  "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/25mL",
  "application_number": "ANDA207321",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dexrazoxane for Injection",
  "start_marketing_date": "20191216",
  "active_numerator_strength": "250"
}

Related drugs

Other records sharing ATC code V03AF02.

Access this data programmatically

Query Dexrazoxane and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.