Feraheme

Orange BookUNII

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

Identification

ManufacturerAMAG Pharmaceuticals, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5933877501
1 VIAL, SINGLE-USE in 1 CARTON (59338-775-01) / 17 mL in 1 VIAL, SINGLE-USE
ndc11
5933877510
10 VIAL, SINGLE-USE in 1 CARTON (59338-775-10) / 17 mL in 1 VIAL, SINGLE-USE

Annotations

UNII (FDA Substance ID)

CLH5FT6412

FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE

RxCUI 473387

Orange Book

N022180

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",
  "productid": "59338-775_69a91fd4-deed-452e-b700-ea68b6e85421",
  "productndc": "59338-775",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "022180",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 510MG IRON/17ML (EQ 30MG IRON/ML)",
        "product_no": "001",
        "approval_date": "Jun 30, 2009"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE",
  "proprietary_name": "Feraheme",
  "active_ingred_unit": "mg/17mL",
  "application_number": "NDA022180",
  "marketing_category": "NDA",
  "nonproprietary_name": "ferumoxytol",
  "start_marketing_date": "20090713",
  "active_numerator_strength": "510"
}

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