Sodium Ferric Gluconate Complex in Sucrose

In shortageOrange BookUNIISPL

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0143929810
10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9298-10) / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9298-01)

Annotations

UNII (FDA Substance ID)

CC9149U2QX

SODIUM FERRIC GLUCONATE COMPLEX

RxCUI 261435

Orange Book

A078215

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Sodium Chloride 0.9% 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": {
    "52430b12-4d5f-d1e1-e063-6394a90abd64": {
      "match": "brand_token",
      "title": "SODIUM FLUORIDE RINSE LIQUID [ROCKLAND COSMETICS, INC.]",
      "spl_version": "1",
      "published_date": "2026-05-21"
    }
  },
  "productid": "0143-9298_4272216c-1e53-4180-a731-0592e772666f",
  "productndc": "0143-9298",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "078215",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)",
        "product_no": "001",
        "approval_date": "Mar 31, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SODIUM FERRIC GLUCONATE COMPLEX",
  "shortage_reason": "Sodium Chloride 0.9% Injection",
  "shortage_status": "current",
  "proprietary_name": "Sodium Ferric Gluconate Complex in Sucrose",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA078215",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sodium Ferric Gluconate Complex in Sucrose",
  "start_marketing_date": "20110331",
  "active_numerator_strength": "12.5"
}

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