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United States · US · US:87081-467_38eff751-96c6-c48a-e063-6294a90a0e48

Desferal

Orange BookUNIISPLATC V03AC01

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

Identification

ManufacturerMITEM PHARMA
CountryUS (United States)
ATC codeV03AC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8708146791
    4 mL in 1 VIAL (87081-467-91)

Annotations

UNII (FDA Substance ID)
V9TKO7EO6K
DEFEROXAMINE MESYLATE
RxCUI 3132
Orange Book
N016267
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "V9TKO7EO6K",
    "rxcui": "3132",
    "inchikey": "IDDIJAWJANBQLJ-UHFFFAOYSA-N",
    "display_name": "DEFEROXAMINE MESYLATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS; SUBCUTANEOUS",
  "spl_meta": {
    "38eff751-96c5-c48a-e063-6294a90a0e48": {
      "match": "brand_token",
      "title": "DESFERAL (DEFEROXAMINE MESYLATE) INJECTION, POWDER, FOR SOLUTION [MITEM PHARMA]",
      "spl_version": "1",
      "published_date": "2025-11-26"
    }
  },
  "productid": "87081-467_38eff751-96c6-c48a-e063-6294a90a0e48",
  "productndc": "87081-467",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "016267",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "500MG/VIAL",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "May 25, 2000"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEFEROXAMINE MESYLATE",
  "proprietary_name": "Desferal",
  "active_ingred_unit": "mg/5mL",
  "application_number": "NDA016267",
  "marketing_category": "NDA",
  "nonproprietary_name": "deferoxamine mesylate",
  "start_marketing_date": "19680402",
  "active_numerator_strength": "500"
}

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