FeraBright

Orange BookUNIISPL

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

Identification

ManufacturerAzurity Pharmaceuticals, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
2433831010
1 VIAL, SINGLE-DOSE in 1 CARTON (24338-310-10) / 10 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

R8DG7T2D3A

FERUMOXYTOL

Orange Book

N219868

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "R8DG7T2D3A",
    "rxcui": null,
    "inchikey": null,
    "display_name": "FERUMOXYTOL",
    "substance_type": "specifiedSubstanceG1",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "ac666008-a14f-43b4-9d06-ec70f45a4234": {
      "match": "brand_token",
      "title": "FERABRIGHT (FERUMOXYTOL) INJECTION [AZURITY PHARMACEUTICALS, INC.]",
      "spl_version": "2",
      "published_date": "2025-11-17"
    }
  },
  "productid": "24338-310_ac5e7507-8e66-4da5-abd9-75ae80369b9f",
  "productndc": "24338-310",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "219868",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 300MG IRON/10ML (EQ 30MG IRON/ML)",
        "product_no": "001",
        "approval_date": "Oct 16, 2025"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 510MG IRON/17ML (EQ 30MG IRON/ML)",
        "product_no": "002",
        "approval_date": "Oct 16, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FERUMOXYTOL",
  "proprietary_name": "FeraBright",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA219868",
  "marketing_category": "NDA",
  "nonproprietary_name": "Ferumoxytol",
  "start_marketing_date": "20251020",
  "active_numerator_strength": "30"
}

Access this data programmatically

Query FeraBright 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.

Get a free API key Read the API docs