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United States · US · US:0404-9879_6dc448fd-d581-4cdb-a4a5-818a41f60c23

INFED

In shortageOrange BookUNIISPLATC V03AE05

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

Identification

ManufacturerHenry Schein, Inc.
CountryUS (United States)
ATC codeV03AE05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0404987902
    1 VIAL, SINGLE-DOSE in 1 BAG (0404-9879-02) / 2 mL in 1 VIAL, SINGLE-DOSE

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": {
    "99bf34be-cb8a-46d1-9637-5544dc2da287": {
      "match": "brand_token",
      "title": "INFED (IRON DEXTRAN) INJECTION [HENRY SCHEIN, INC.]",
      "spl_version": "7",
      "published_date": "2026-04-24"
    }
  },
  "productid": "0404-9879_6dc448fd-d581-4cdb-a4a5-818a41f60c23",
  "productndc": "0404-9879",
  "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": "INFED",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA017441",
  "marketing_category": "NDA",
  "nonproprietary_name": "iron dextran",
  "start_marketing_date": "20220111",
  "active_numerator_strength": "50"
}

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