Venofer

In shortageOrange BookUNIISPLATC B03AB02

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

Identification

ManufacturerAmerican Regent, Inc.

CountryUS (United States)

ATC codeB03AB02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0517232510
10 VIAL, SINGLE-DOSE in 1 BOX (0517-2325-10) / 2.5 mL in 1 VIAL, SINGLE-DOSE (0517-2325-01)

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": "0517-2325_500b09f8-36f1-4842-8d07-246fea7bdfd0",
  "productndc": "0517-2325",
  "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"
}

Related drugs

Other records sharing ATC code B03AB02.

Access this data programmatically

Query Venofer and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs