cardioplegic solution

Generic: potassium chloride, sodium chloride, calcium chloride, and magnesium chloride

Labeler: fresenius kabi, usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cardioplegic solution
Generic Name potassium chloride, sodium chloride, calcium chloride, and magnesium chloride
Labeler fresenius kabi, usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRA-ARTERIAL
Active Ingredients

calcium chloride 17.6 mg/100mL, magnesium chloride 325.3 mg/100mL, potassium chloride 119.3 mg/100mL, sodium chloride 643 mg/100mL

Manufacturer
Fresenius Kabi, USA, LLC

Identifiers & Regulatory

Product NDC 65219-258
Product ID 65219-258_9c1af4dc-3653-49cb-baa5-e916369a4e0a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214623
Listing Expiration 2026-12-31
Marketing Start 2022-06-06

Pharmacologic Class

Classes
blood coagulation factor [epc] calcium [cs] calculi dissolution agent [epc] cations divalent [cs] increased coagulation factor activity [pe] increased large intestinal motility [pe] inhibition large intestine fluid/electrolyte absorption [pe] inhibition small intestine fluid/electrolyte absorption [pe] magnesium ion exchange activity [moa] osmotic activity [moa] osmotic laxative [epc] potassium compounds [cs] potassium salt [epc] stimulation large intestine fluid/electrolyte secretion [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65219258
Hyphenated Format 65219-258

Supplemental Identifiers

UNII
M4I0D6VV5M 02F3473H9O 660YQ98I10 451W47IQ8X

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name cardioplegic solution (source: ndc)
Generic Name potassium chloride, sodium chloride, calcium chloride, and magnesium chloride (source: ndc)
Application Number ANDA214623 (source: ndc)
Routes
INTRA-ARTERIAL
source: ndc

Resolved Composition

Strengths
  • 17.6 mg/100mL
  • 325.3 mg/100mL
  • 119.3 mg/100mL
  • 643 mg/100mL
source: ndc
Packaging
  • 10 POUCH in 1 CASE (65219-258-10) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG (65219-258-01)
source: ndc

Packages (1)

Ingredients (4)

calcium chloride (17.6 mg/100mL) magnesium chloride (325.3 mg/100mL) potassium chloride (119.3 mg/100mL) sodium chloride (643 mg/100mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRA-ARTERIAL"], "spl_id": "9c1af4dc-3653-49cb-baa5-e916369a4e0a", "openfda": {"unii": ["M4I0D6VV5M", "02F3473H9O", "660YQ98I10", "451W47IQ8X"], "spl_set_id": ["eb360dc4-88d6-4b28-9b61-bc359e16bd22"], "manufacturer_name": ["Fresenius Kabi, USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 POUCH in 1 CASE (65219-258-10)  / 1 BAG in 1 POUCH / 1000 mL in 1 BAG (65219-258-01)", "package_ndc": "65219-258-10", "marketing_start_date": "20220606"}], "brand_name": "Cardioplegic Solution", "product_id": "65219-258_9c1af4dc-3653-49cb-baa5-e916369a4e0a", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Blood Coagulation Factor [EPC]", "Calcium [CS]", "Calculi Dissolution Agent [EPC]", "Cations", "Divalent [CS]", "Increased Coagulation Factor Activity [PE]", "Increased Large Intestinal Motility [PE]", "Increased Large Intestinal Motility [PE]", "Increased Large Intestinal Motility [PE]", "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]", "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]", "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]", "Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]", "Magnesium Ion Exchange Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Osmotic Laxative [EPC]", "Osmotic Laxative [EPC]", "Potassium Compounds [CS]", "Potassium Salt [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "65219-258", "generic_name": "POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, and MAGNESIUM CHLORIDE", "labeler_name": "Fresenius Kabi, USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cardioplegic Solution", "active_ingredients": [{"name": "CALCIUM CHLORIDE", "strength": "17.6 mg/100mL"}, {"name": "MAGNESIUM CHLORIDE", "strength": "325.3 mg/100mL"}, {"name": "POTASSIUM CHLORIDE", "strength": "119.3 mg/100mL"}, {"name": "SODIUM CHLORIDE", "strength": "643 mg/100mL"}], "application_number": "ANDA214623", "marketing_category": "ANDA", "marketing_start_date": "20220606", "listing_expiration_date": "20261231"}