Search Icon

0409-7969 NDC - PLEGISOL (POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDE)

Drug Information

Product NDC: 0409-7969

Proprietary Name: Plegisol

Non Proprietary Name: POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, and MAGNESIUM CHLORIDE

Active Ingredient(s):
  • 17.6 mg/100mL CALCIUM CHLORIDE;
  • 325.3 mg/100mL MAGNESIUM CHLORIDE;
  • 119.3 mg/100mL POTASSIUM CHLORIDE;
  • 643 mg/100mL SODIUM CHLORIDE


Administration Route(s): INTRA-ARTERIAL

Dosage Form(s): INJECTION, SOLUTION

Pharmacy Class(es):
  • 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]

Labeler Information

Labeler Name: Hospira, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA018608
Marketing Category: NDA
Start Marketing Date:7/28/2005

Package Information

No. Package Code Package Description Billing Unit
10409-7969-0512 POUCH in 1 CASE (0409-7969-05) > 1 BAG in 1 POUCH > 1000 mL in 1 BAG (0409-7969-11)ML

NDC Record

Field Name Field Value Definition
PRODUCT NDC0409-7969The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEPlegisolThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEPOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, and MAGNESIUM CHLORIDEThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEINJECTION, SOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEINTRA-ARTERIALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE7/28/2005This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA018608This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEHospira, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMECALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDEAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH17.6; 325.3; 119.3; 643 
ACTIVE INGRED UNITmg/100mL; mg/100mL; mg/100mL; mg/100mL 
PHARM CLASSESBlood 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] 

Download Record

Download this NDC record in Text format: Export

Download this NDC record in Excel (CSV) format: Export

Download this NDC record in XML format: Export

This page was last updated on: 10/28/2022