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United States · US · US:51662-1441_2b3948f4-fdef-5321-e063-6394a90ad70c

IRON DEXTRAN

In shortageOrange BookUNIISPLATC V03AE05

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

Identification

ManufacturerHF Acquisition Co LLC, DBA HealthFirst
CountryUS (United States)
ATC codeV03AE05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5166214411
    2 mL in 1 VIAL, SINGLE-DOSE (51662-1441-1)

Annotations

UNII (FDA Substance ID)
95HR524N2M
IRON DEXTRAN
RxCUI 5992
Orange Book
N017441
BP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Iron Sucrose Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "95HR524N2M",
    "rxcui": "5992",
    "inchikey": null,
    "display_name": "IRON DEXTRAN",
    "substance_type": "polymer",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRAVENOUS",
  "spl_meta": {
    "6f19c80e-22e9-4bab-aa53-4d2d958119ed": {
      "match": "brand_token",
      "title": "IRON SUCROSE INJECTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED]",
      "spl_version": "4",
      "published_date": "2026-05-13"
    }
  },
  "productid": "51662-1441_2b3948f4-fdef-5321-e063-6394a90ad70c",
  "productndc": "51662-1441",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "017441",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "BP",
        "strength": "EQ 100MG IRON/2ML (EQ 50MG IRON/ML)",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IRON DEXTRAN",
  "shortage_reason": "Iron Sucrose Injection",
  "shortage_status": "current",
  "proprietary_name": "IRON DEXTRAN",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA017441",
  "marketing_category": "NDA",
  "nonproprietary_name": "IRON DEXTRAN",
  "start_marketing_date": "20191222",
  "active_numerator_strength": "50"
}

Related drugs

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