Prescription drug · ANDA
Cardioplegic Solution NDC 65219-258
potassium chloride, sodium chloride, calcium chloride, and magnesium chloride · Potassium chloride 119.3 mg/100mL + 3 more ingredients · Injection, Solution · Intra-arterial · Fresenius Kabi, USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65219-258-10 | 65219025810 | 10 POUCH in 1 CASE (65219-258-10) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG (65219-258-01)Marketed from Jun 6, 2022 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Cardioplegic Solution
- Generic name (nonproprietary)
- potassium chloride, sodium chloride, calcium chloride, and magnesium chloride
- Active ingredients
- Potassium chloride — 119.3 mg/100mLSodium chloride — 643 mg/100mLCalcium chloride — 17.6 mg/100mLMagnesium chloride — 325.3 mg/100mL
- Dosage form
- Injection, Solution
- Route
- Intra-arterial
- Labeler
- Fresenius Kabi, USA, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214623
- Marketing start
- Listing expires
- Other FDA classes
- Calcium (Chemical structure)Divalent (Chemical structure)Increased Coagulation Factor Activity (Physiologic effect)Increased Large Intestinal Motility (Physiologic effect)Increased Large Intestinal Motility (Physiologic effect)Increased Large Intestinal Motility (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Inhibition Small Intestine Fluid/Electrolyte Absorption (Physiologic effect)Magnesium Ion Exchange Activity (Mechanism)Osmotic Activity (Mechanism)Osmotic Activity (Mechanism)Osmotic Activity (Mechanism)Potassium Compounds (Chemical structure)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
- Identifiers
- Product ID 65219-258_9c1af4dc-3653-49cb-baa5-e916369a4e0aSPL ID 9c1af4dc-3653-49cb-baa5-e916369a4e0aSPL set ID eb360dc4-88d6-4b28-9b61-bc359e16bd22UNII 660YQ98I10, 451W47IQ8X, M4I0D6VV5M, 02F3473H9O
- Pharmacologic class
- Blood Coagulation Factor; Calculi Dissolution Agent; Osmotic Laxative; Potassium Salt
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N465219025810followed by a unit qualifier and the quantityPackage 65219-0258-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Cardioplegic Solution when suitably buffered in combination with ischemia and hypothermia is used to induce cardiac arrest during open heart surgery.
Excerpt only. Read the full label for complete information.