Deferoxamine mesylate

Orange BookUNIISPLATC V03AC01

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

Identification

ManufacturerGland Pharma Limited

CountryUS (United States)

ATC codeV03AC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6808317201
4 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (68083-172-01)

Annotations

UNII (FDA Substance ID)

V9TKO7EO6K

DEFEROXAMINE MESYLATE

RxCUI 3132

Orange Book

A207384

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": "68083-172_d14a31c5-4e8d-4e3e-b38f-d73ffddfb629",
  "productndc": "68083-172",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "207384",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "500MG/VIAL",
        "product_no": "001",
        "approval_date": "Sep 29, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "2GM/VIAL",
        "product_no": "002",
        "approval_date": "Sep 29, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEFEROXAMINE MESYLATE",
  "proprietary_name": "Deferoxamine mesylate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA207384",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Deferoxamine mesylate",
  "start_marketing_date": "20171009",
  "active_numerator_strength": "500"
}

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