Deferoxamine

Orange BookUNIISPLATC V03AC01

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

Identification

ManufacturerFresenius Kabi USA, LLC

CountryUS (United States)

ATC codeV03AC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6332359710
1 VIAL in 1 BOX (63323-597-10) / 5.3 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

V9TKO7EO6K

DEFEROXAMINE MESYLATE

RxCUI 3132

Orange Book

A078718

APAP

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": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
  "spl_meta": {
    "598fba68-f46e-4b6e-894c-63c2940b2063": {
      "match": "brand_token",
      "title": "DEFEROXAMINE MESYLATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED]",
      "spl_version": "6",
      "published_date": "2026-06-02"
    }
  },
  "productid": "63323-597_6e384a23-a8c4-455a-b84b-847393d491e6",
  "productndc": "63323-597",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "078718",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "500MG/VIAL",
        "product_no": "001",
        "approval_date": "Sep 15, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "2GM/VIAL",
        "product_no": "002",
        "approval_date": "Sep 15, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEFEROXAMINE MESYLATE",
  "proprietary_name": "Deferoxamine",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA078718",
  "marketing_category": "ANDA",
  "nonproprietary_name": "DEFEROXAMINE MESYLATE",
  "start_marketing_date": "20091215",
  "active_numerator_strength": "95"
}

Related drugs

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