0941-0717 NDC - EXTRANEAL (ICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE)

Drug Information

  • Product NDC: 0941-0717
  • Proprietary Name: EXTRANEAL
  • Non Proprietary Name: icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride
  • Active Ingredient(s): 25.7 mg/100mL CALCIUM CHLORIDE; 7.5 g/100mL ICODEXTRIN; 5.1 mg/100mL MAGNESIUM CHLORIDE; 540 mg/100mL SODIUM CHLORIDE; 450 mg/100mL SODIUM LACTATE
  • Administration Route(s): INTRAPERITONEAL
  • 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]; Phosphate Binder [EPC]; Phosphate Chelating Activity [MoA]; Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]

Labeler Information

Field Name Field Value
Labeler Name: Vantive US Healthcare LLC
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number:
Marketing Category: UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
Start Marketing Date:10/21/2024
End Marketing Date:7/31/2026

Package Information

No. Package Code Package Description Billing Unit
10941-0717-055 BAG in 1 CARTON (0941-0717-05) / 2000 mL in 1 BAG (0941-0717-01)

NDC Record

Field Name Field Value Definition
PRODUCT NDC0941-0717The 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 NAMEEXTRANEALThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEicodextrin, sodium chloride, sodium lactate, calcium chloride, 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 NAMEINTRAPERITONEALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE10/21/2024This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE7/31/2026This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
MARKETING CATEGORY NAMEUNAPPROVED DRUG FOR USE IN DRUG SHORTAGEProduct 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.
LABELER NAMEVantive US Healthcare LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMECALCIUM CHLORIDE; ICODEXTRIN; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATEAn 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 STRENGTH25.7; 7.5; 5.1; 540; 450 
ACTIVE INGRED UNITmg/100mL; g/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], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 

Download Record

Download this NDC record record in Text format: Export

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

Download this NDC record record in XML format: Export

This page was last updated on: 5/9/2025

Previous Code
Next Code