Venofer

In shortageOrange BookUNIISPLATC B03AB02

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

Identification

ManufacturerFresenius Medical Care Holdings, Inc.

CountryUS (United States)

ATC codeB03AB02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
4923053010
10 VIAL, SINGLE-DOSE in 1 BOX (49230-530-10) / 2.5 mL in 1 VIAL, SINGLE-DOSE (49230-530-01)
ndc11
4923053025
25 VIAL, SINGLE-DOSE in 1 TRAY (49230-530-25) / 2.5 mL in 1 VIAL, SINGLE-DOSE (49230-530-01)

Annotations

UNII (FDA Substance ID)

FZ7NYF5N8L

IRON SUCROSE

RxCUI 24909

Orange Book

N021135

ABABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Iron Sucrose Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "FZ7NYF5N8L",
    "rxcui": "24909",
    "inchikey": null,
    "display_name": "IRON SUCROSE",
    "substance_type": "polymer",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "b998ef36-81fa-40a1-9cd1-6d6156f91564": {
      "match": "brand_token",
      "title": "VENOFER (IRON SUCROSE) INJECTION, SOLUTION [AMERICAN REGENT, INC.]",
      "spl_version": "12",
      "published_date": "2026-03-20"
    }
  },
  "productid": "49230-530_e12cb876-ae80-416b-9bd3-a1cc83c9e666",
  "productndc": "49230-530",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "021135",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 100MG IRON/5ML (EQ 20MG IRON/ML)",
        "product_no": "001",
        "approval_date": "Nov 6, 2000"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML)",
        "product_no": "002",
        "approval_date": "Mar 20, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 75MG IRON/3.75ML (EQ 20MG IRON/ML)",
        "product_no": "003",
        "approval_date": "Mar 29, 2005"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 200MG IRON/10ML (EQ 20MG IRON/ML)",
        "product_no": "004",
        "approval_date": "Feb 9, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 65MG IRON/3.25ML (EQ 20MG IRON/ML)",
        "product_no": "005",
        "approval_date": "Mar 29, 2013"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IRON SUCROSE",
  "shortage_reason": "Iron Sucrose Injection",
  "shortage_status": "current",
  "proprietary_name": "Venofer",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA021135",
  "marketing_category": "NDA",
  "nonproprietary_name": "iron sucrose",
  "start_marketing_date": "20110127",
  "active_numerator_strength": "20"
}

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