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United States · US · US:0024-2794_df1cd4cc-f035-435c-a17e-381071f0d9e1

Ferrlecit

In shortageOrange BookUNIISPL

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

Identification

Manufacturersanofi-aventis U.S. LLC
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 0

No packs registered.

Annotations

UNII (FDA Substance ID)
CC9149U2QX
SODIUM FERRIC GLUCONATE COMPLEX
RxCUI 261435
Orange Book
N020955
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Sodium Bicarbonate Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "CC9149U2QX",
    "rxcui": "261435",
    "inchikey": "MQBDAEHWGRMADS-XNHLMZCASA-M",
    "display_name": "SODIUM FERRIC GLUCONATE COMPLEX",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "b25b34ab-9cf1-4a2b-bdf2-5eaf66625999": {
      "match": "brand_token",
      "title": "FERRLECIT (SODIUM FERRIC GLUCONATE COMPLEX) INJECTION [SANOFI-AVENTIS U.S. LLC]",
      "spl_version": "12",
      "published_date": "2025-11-27"
    }
  },
  "productid": "0024-2794_df1cd4cc-f035-435c-a17e-381071f0d9e1",
  "productndc": "0024-2794",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "020955",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)",
        "product_no": "001",
        "approval_date": "Feb 18, 1999"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SODIUM FERRIC GLUCONATE COMPLEX",
  "shortage_reason": "Sodium Bicarbonate Injection",
  "shortage_status": "current",
  "proprietary_name": "Ferrlecit",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA020955",
  "marketing_category": "NDA",
  "nonproprietary_name": "sodium ferric gluconate complex",
  "start_marketing_date": "20140707",
  "active_numerator_strength": "12.5"
}

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