Potassium Chloride in Dextrose and Sodium Chloride

Product NDC
65219-142
11-digit product format
652190142
Labeler code
65219
Product ID
65219-142_93737cd2-f9e0-41e1-9263-2c4ff516395a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA213523
Marketing category
ANDA
Marketing start
2022-08-26
Substance
DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
Active strength
50; .745; 4.5 g/1000mL; g/1000mL; g/1000mL
Pharmacologic classes
Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Potassium Chloride in Dextrose and Sodium Chloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROSE MONOHYDRATE50 g/1000mL
POTASSIUM CHLORIDE.745 g/1000mL
SODIUM CHLORIDE4.5 g/1000mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii451W47IQ8X, 660YQ98I10, LX22YL083G
Rxcui615099, 615100, 630796, 1863605, 1863607

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-142-02Potassium Chloride in Dextrose and Sodium Chloride1000 mL in 1 BAGINJECTION, SOLUTION10007
65219-142-10Potassium Chloride in Dextrose and Sodium Chloride10 in 1 CASEINJECTION, SOLUTION107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-142-02ML - Milliliter65219-142e487528c-a069-4ae4-9b1f-a50a1598191512023-06-06
65219-142-10ML - Milliliter65219-1426d55d6fb-a657-4322-80ef-eea45e12217112023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-142POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]7Current NDC, Legacy NDC, 2 package rows20240509_fe5b5182-c859-4c74-b2e0-467be5b2e329.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1863607potassium chloride 10 MEQ / dextrose 5 % / sodium chloride 0.45 % in 500 ML InjectionPSNfe5b5182-c859-4c74-b2e0-467be5b2e3297
630796potassium chloride 10 MEQ / dextrose 5 % / sodium chloride 0.45 % per 1000 ML InjectionPSNfe5b5182-c859-4c74-b2e0-467be5b2e3297
1863605potassium chloride 20 MEQ / dextrose 5 % / sodium chloride 0.45 % in 1000 ML InjectionPSNfe5b5182-c859-4c74-b2e0-467be5b2e3297
615099potassium chloride 30 MEQ / dextrose 5 % / sodium chloride 0.45 % in 1000 ML InjectionPSNfe5b5182-c859-4c74-b2e0-467be5b2e3297
615100potassium chloride 40 MEQ / dextrose 5 % / sodium chloride 0.45 % in 1000 ML InjectionPSNfe5b5182-c859-4c74-b2e0-467be5b2e3297
6307961000 ML glucose 50 MG/ML / potassium chloride 0.01 MEQ/ML / sodium chloride 4.5 MG/ML InjectionSCDfe5b5182-c859-4c74-b2e0-467be5b2e3297
18636051000 ML glucose 50 MG/ML / potassium chloride 0.02 MEQ/ML / sodium chloride 4.5 MG/ML InjectionSCDfe5b5182-c859-4c74-b2e0-467be5b2e3297
6150991000 ML glucose 50 MG/ML / potassium chloride 0.03 MEQ/ML / sodium chloride 4.5 MG/ML InjectionSCDfe5b5182-c859-4c74-b2e0-467be5b2e3297
6151001000 ML glucose 50 MG/ML / potassium chloride 0.04 MEQ/ML / sodium chloride 4.5 MG/ML InjectionSCDfe5b5182-c859-4c74-b2e0-467be5b2e3297
1863607500 ML glucose 50 MG/ML / potassium chloride 0.02 MEQ/ML / sodium chloride 4.5 MG/ML InjectionSCDfe5b5182-c859-4c74-b2e0-467be5b2e3297
6307961000 ML Glucose 50 MG/ML / K+ Chloride 0.01 MEQ/ML / NaCl 4.5 MG/ML InjectionSYfe5b5182-c859-4c74-b2e0-467be5b2e3297
18636051000 ML Glucose 50 MG/ML / K+ Chloride 0.02 MEQ/ML / NaCl 4.5 MG/ML InjectionSYfe5b5182-c859-4c74-b2e0-467be5b2e3297
6150991000 ML Glucose 50 MG/ML / K+ Chloride 0.03 MEQ/ML / NaCl 4.5 MG/ML InjectionSYfe5b5182-c859-4c74-b2e0-467be5b2e3297
6151001000 ML Glucose 50 MG/ML / K+ Chloride 0.04 MEQ/ML / NaCl 4.5 MG/ML InjectionSYfe5b5182-c859-4c74-b2e0-467be5b2e3297
6307961000 ML Glucose 50 MG/ML / Pot Chloride 0.01 MEQ/ML / NaCl 4.5 MG/ML InjectionSYfe5b5182-c859-4c74-b2e0-467be5b2e3297
18636051000 ML Glucose 50 MG/ML / Pot Chloride 0.02 MEQ/ML / NaCl 4.5 MG/ML InjectionSYfe5b5182-c859-4c74-b2e0-467be5b2e3297
6150991000 ML Glucose 50 MG/ML / Pot Chloride 0.03 MEQ/ML / NaCl 4.5 MG/ML InjectionSYfe5b5182-c859-4c74-b2e0-467be5b2e3297
6151001000 ML Glucose 50 MG/ML / Pot Chloride 0.04 MEQ/ML / NaCl 4.5 MG/ML InjectionSYfe5b5182-c859-4c74-b2e0-467be5b2e3297
1863607500 ML Glucose 50 MG/ML / K+ Chloride 0.02 MEQ/ML / NaCl 4.5 MG/ML InjectionSYfe5b5182-c859-4c74-b2e0-467be5b2e3297
1863607500 ML Glucose 50 MG/ML / Pot Chloride 0.02 MEQ/ML / NaCl 4.5 MG/ML InjectionSYfe5b5182-c859-4c74-b2e0-467be5b2e3297
630796potassium chloride 10 MEQ / dextrose 5 % / sodium chloride 0.45 % per 1000 ML InjectionSYfe5b5182-c859-4c74-b2e0-467be5b2e3297
1863607potassium chloride 10 MEQ / dextrose 5 % / sodium chloride 0.45 % per 500 ML InjectionSYfe5b5182-c859-4c74-b2e0-467be5b2e3297
1863605potassium chloride 20 MEQ / dextrose 5 % / sodium chloride 0.45 % per 1000 ML InjectionSYfe5b5182-c859-4c74-b2e0-467be5b2e3297
615099potassium chloride 30 MEQ / dextrose 5 % / sodium chloride 0.45 % per 1000 ML InjectionSYfe5b5182-c859-4c74-b2e0-467be5b2e3297
615100potassium chloride 40 MEQ / dextrose 5 % / sodium chloride 0.45 % per 1000 ML InjectionSYfe5b5182-c859-4c74-b2e0-467be5b2e3297

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65219-142-02652190142021000 mL in 1 BAG1000 mlHistorical
65219-142-106521901421010 BAG in 1 CASE (65219-142-10) / 1000 mL in 1 BAG (65219-142-02) 10 bag2022-08-260000-00-00NoNoCurrent