Home NDC 0941-0719 EXTRANEAL
Product NDC 0941-0719
11-digit product format 009410719
Labeler code 0941
Product ID 0941-0719_348e2829-a0c9-3ee6-e063-6294a90a585d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride
Dosage form INJECTION, SOLUTION
Route INTRAPERITONEAL
Labeler Vantive US Healthcare LLC
Marketing category UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
Marketing start 2024-10-21
Marketing end 2026-08-31
Substance CALCIUM CHLORIDE; ICODEXTRIN; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
Active strength 25.7; 7.5; 5.1; 540; 450 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL
Pharmacologic classes 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]
NDC exclude flag No
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base EXTRANEAL Active Ingredients# Ingredient, Strength table Ingredient Strength ICODEXTRIN 25.7 mg/100mL SODIUM CHLORIDE 7.5 g/100mL SODIUM LACTATE 5.1 mg/100mL CALCIUM CHLORIDE 540 mg/100mL MAGNESIUM CHLORIDE 450 mg/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 5 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1100742 Internal RxNorm lookup 1100746 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0941-0719-01 EXTRANEAL 2000 mL in 1 BAG INJECTION, SOLUTION 2000 6 0941-0719-05 EXTRANEAL 5 in 1 CARTON INJECTION, SOLUTION 5 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0941-0719 EXTRANEAL (ICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE) INJECTION, SOLUTION [VANTIVE US HEALTHCARE LLC] 6 Current NDC, 2 package rows 20250508_2b327b13-a0e9-4b2c-9875-4470998e2e30.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join EXTRANEAL ICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE Vantive US Healthcare LLC 2b327b13-a0e9-4b2c-9875-4470998e2e30 2025-05-07 Exact identifier ndc (product): 0941-0719
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 1100746 Extraneal 0.00232 MEQ/mL / 75 MG/mL / 0.000533 MEQ/mL / 0.0915 MEQ/mL / 0.04 MEQ/mL Injectable Solution PSN 2b327b13-a0e9-4b2c-9875-4470998e2e30 6 1100746 calcium chloride 0.00232 MEQ/ML / icodextrin 75 MG/ML / magnesium chloride 0.000533 MEQ/ML / sodium chloride 0.0915 MEQ/ML / sodium lactate 0.04 MEQ/ML Injectable Solution [Extraneal] SBD 2b327b13-a0e9-4b2c-9875-4470998e2e30 6 1100742 calcium chloride 0.00232 MEQ/ML / icodextrin 75 MG/ML / magnesium chloride 0.000533 MEQ/ML / sodium chloride 0.0915 MEQ/ML / sodium lactate 0.04 MEQ/ML Injectable Solution SCD 2b327b13-a0e9-4b2c-9875-4470998e2e30 6 1100742 Calcium Chloride 0.00232 MEQ/ML / icodextrin 75 MG/ML / Magnesium Chloride 0.000533 MEQ/ML / NaCl 0.0915 MEQ/ML / Sodium Lactate 0.04 MEQ/ML Injectable Solution SY 2b327b13-a0e9-4b2c-9875-4470998e2e30 6 1100746 Calcium Chloride 0.00232 MEQ/ML / icodextrin 75 MG/ML / Magnesium Chloride 0.000533 MEQ/ML / NaCl 0.0915 MEQ/ML / Sodium Lactate 0.04 MEQ/ML Injectable Solution [Extraneal] SY 2b327b13-a0e9-4b2c-9875-4470998e2e30 6 1100746 Extraneal (calcium chloride 25.7 MG / icodextrin 7.5 GM / magnesium chloride 5.08 MG / sodium chloride 535 MG / sodium lactate 448 MG) per 100 ML Intraperitoneal Solution SY 2b327b13-a0e9-4b2c-9875-4470998e2e30 6
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0941-0719-01 00941071901 2000 mL in 1 BAG 2000 ml Historical 0941-0719-05 00941071905 5 BAG in 1 CARTON (0941-0719-05) / 2000 mL in 1 BAG (0941-0719-01) 5 bag 2024-10-21 2026-08-31 No No Historical