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
IngredientStrength
CALCIUM CHLORIDE25.7 mg/100mL
ICODEXTRIN7.5 g/100mL
MAGNESIUM CHLORIDE5.1 mg/100mL
SODIUM CHLORIDE540 mg/100mL
SODIUM LACTATE450 mg/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM4I0D6VV5M, 02F3473H9O, 451W47IQ8X, 2NX48Z0A9G, TU7HW0W0QT
Rxcui1100742, 1100746

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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95250459-30e4-45c1-b08a-993044f49109Product name220250805
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2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0941-0719-01EXTRANEAL2000 mL in 1 BAGINJECTION, SOLUTION20006
0941-0719-05EXTRANEAL5 in 1 CARTONINJECTION, SOLUTION56

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0941-0719EXTRANEAL (ICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE) INJECTION, SOLUTION [VANTIVE US HEALTHCARE LLC]6Current NDC, 2 package rows20250508_2b327b13-a0e9-4b2c-9875-4470998e2e30.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100746Extraneal 0.00232 MEQ/mL / 75 MG/mL / 0.000533 MEQ/mL / 0.0915 MEQ/mL / 0.04 MEQ/mL Injectable SolutionPSN2b327b13-a0e9-4b2c-9875-4470998e2e306
1100746calcium 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]SBD2b327b13-a0e9-4b2c-9875-4470998e2e306
1100742calcium 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 SolutionSCD2b327b13-a0e9-4b2c-9875-4470998e2e306
1100742Calcium 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 SolutionSY2b327b13-a0e9-4b2c-9875-4470998e2e306
1100746Calcium 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]SY2b327b13-a0e9-4b2c-9875-4470998e2e306
1100746Extraneal (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 SolutionSY2b327b13-a0e9-4b2c-9875-4470998e2e306

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0941-0719-01009410719012000 mL in 1 BAG2000 mlHistorical
0941-0719-05009410719055 BAG in 1 CARTON (0941-0719-05) / 2000 mL in 1 BAG (0941-0719-01) 5 bag2024-10-212026-08-31NoNoHistorical