Iron Sucrose

In shortageOrange BookUNIISPLATC B03AB02

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

Identification

ManufacturerMylan Institutional LLC

CountryUS (United States)

ATC codeB03AB02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6745763810
10 VIAL, SINGLE-DOSE in 1 CARTON (67457-638-10) / 5 mL in 1 VIAL, SINGLE-DOSE
ndc11
6745763825
25 VIAL, SINGLE-DOSE in 1 CARTON (67457-638-25) / 5 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

FZ7NYF5N8L

IRON SUCROSE

RxCUI 24909

Orange Book

A212559

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": {
    "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": "67457-638_3f109bdb-a412-43b2-84c7-9dad05e85a71",
  "productndc": "67457-638",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "212559",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML)",
        "product_no": "001",
        "approval_date": "Aug 8, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG IRON/5ML (EQ 20MG IRON/ML)",
        "product_no": "002",
        "approval_date": "Aug 8, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 200MG IRON/10ML (EQ 20MG IRON/ML)",
        "product_no": "003",
        "approval_date": "Aug 8, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IRON SUCROSE",
  "shortage_reason": "Iron Sucrose Injection",
  "shortage_status": "current",
  "proprietary_name": "Iron Sucrose",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA212559",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Iron Sucrose",
  "start_marketing_date": "20250811",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code B03AB02.

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