Monoferric

Orange BookUNIISPL

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

Identification

ManufacturerPharmacosmos Therapeutics Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7359493101
1 VIAL in 1 BOX (73594-9310-1) / 10 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

AHU547PI9H

FERRIC DERISOMALTOSE

RxCUI 2274394

Orange Book

N208171

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "AHU547PI9H",
    "rxcui": "2274394",
    "inchikey": null,
    "display_name": "FERRIC DERISOMALTOSE",
    "substance_type": "polymer",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "55859d2d-0456-4fa9-b41f-f535accc97db": {
      "match": "brand_token",
      "title": "MONOFERRIC (FERRIC DERISOMALTOSE) INJECTION, SOLUTION [PHARMACOSMOS THERAPEUTICS INC.]",
      "spl_version": "13",
      "published_date": "2025-12-10"
    }
  },
  "productid": "73594-9310_ddb3125c-a423-4256-9017-6e614ae2263d",
  "productndc": "73594-9310",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "208171",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "100MG/ML (100MG/ML)",
        "product_no": "001",
        "approval_date": "Jan 16, 2020"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "500MG/5ML (100MG/ML)",
        "product_no": "002",
        "approval_date": "Jan 16, 2020"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1GM/10ML (100MG/ML)",
        "product_no": "003",
        "approval_date": "Jan 16, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FERRIC DERISOMALTOSE",
  "proprietary_name": "Monoferric",
  "active_ingred_unit": "mg/10mL",
  "application_number": "NDA208171",
  "marketing_category": "NDA",
  "nonproprietary_name": "Ferric derisomaltose",
  "start_marketing_date": "20200116",
  "active_numerator_strength": "1000"
}

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