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United States · US · US:65219-258_9c1af4dc-3653-49cb-baa5-e916369a4e0a

Cardioplegic Solution

In shortageOrange BookUNIISPLATC C03CB

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

Identification

ManufacturerFresenius Kabi, USA, LLC
CountryUS (United States)
ATC codeC03CB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6521925810
    10 POUCH in 1 CASE (65219-258-10) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG (65219-258-01)

Annotations

UNII (FDA Substance ID)
M4I0D6VV5M
CALCIUM CHLORIDE
RxCUI 221068
Orange Book
A214623
AT
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Calcium Chloride Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "M4I0D6VV5M",
    "rxcui": "221068",
    "inchikey": "LLSDKQJKOVVTOJ-UHFFFAOYSA-L",
    "display_name": "CALCIUM CHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRA-ARTERIAL",
  "spl_meta": {
    "1fd50ce5-2799-4c26-81da-02cf0578dd9e": {
      "match": "brand_token",
      "title": "CARDIOPLEGIC (CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM CHLORIDE) SOLUTION [BAXTER HEALTHCARE CORPORATION]",
      "spl_version": "13",
      "published_date": "2026-04-15"
    }
  },
  "productid": "65219-258_9c1af4dc-3653-49cb-baa5-e916369a4e0a",
  "productndc": "65219-258",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "214623",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML",
        "product_no": "001",
        "approval_date": "Feb 18, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE",
  "shortage_reason": "Calcium Chloride Injection",
  "shortage_status": "current",
  "proprietary_name": "Cardioplegic Solution",
  "active_ingred_unit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL",
  "application_number": "ANDA214623",
  "marketing_category": "ANDA",
  "nonproprietary_name": "POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, and MAGNESIUM CHLORIDE",
  "start_marketing_date": "20220606",
  "active_numerator_strength": "17.6; 325.3; 119.3; 643"
}

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