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United States Β· US Β· US:0781-3154_7374e3ff-0761-45f0-bb76-bf1b74a20480

Ferumoxytol

Orange BookUNIISPL

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

Identification

ManufacturerSandoz Inc
CountryUS (United States)
ATC codeβ€”
Dispensingβ€”
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs Β· 2

  • ndc11
    0781315401
    1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3154-01) / 17 mL in 1 VIAL, SINGLE-DOSE
  • ndc11
    0781315495
    10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3154-95) / 17 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
CLH5FT6412
FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE
RxCUI 473387
Orange Book
A206604
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "CLH5FT6412",
    "rxcui": "473387",
    "inchikey": "WTFXARWRTYJXII-UHFFFAOYSA-N",
    "display_name": "FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "cf94c7fc-13a0-4ac9-bb85-9c38aa704d35": {
      "match": "brand_token",
      "title": "FERUMOXYTOL INJECTION [SANDOZ INC]",
      "spl_version": "6",
      "published_date": "2026-03-03"
    }
  },
  "productid": "0781-3154_7374e3ff-0761-45f0-bb76-bf1b74a20480",
  "productndc": "0781-3154",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "206604",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 510MG IRON/17ML (EQ 30MG IRON/ML)",
        "product_no": "001",
        "approval_date": "Jan 15, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE",
  "proprietary_name": "Ferumoxytol",
  "active_ingred_unit": "mg/17mL",
  "application_number": "ANDA206604",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ferumoxytol",
  "start_marketing_date": "20210715",
  "active_numerator_strength": "510"
}

Access this data programmatically

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Ferumoxytol (US) β€” Drug Database