FDA.reportPublic FDA data

Potassium Chloride in Dextrose and Sodium Chloride

Product NDC
0338-0807
11-digit product format
003380807
Labeler code
0338
Product ID
0338-0807_34c74d23-f49a-4e1c-9ffe-9a200d0fffe7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Chloride, Dextrose Monohydrate and Sodium Chloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Company
Application
NDA019308
Marketing category
NDA
Marketing start
1985-04-05
Substance
DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
Active strength
5; 300; 900 g/100mL; mg/100mL; mg/100mL
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 MONOHYDRATE5 g/100mL
POTASSIUM CHLORIDE300 mg/100mL
SODIUM CHLORIDE900 mg/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii451W47IQ8X, LX22YL083G, 660YQ98I10
Rxcui615099, 615100, 615107, 615111, 630796, 1863605, 1863607, 1863973, 1863975, 1863988

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
0338-0807-04Potassium Chloride in Dextrose and Sodium Chloride1000 mL in 1 BAGINJECTION, SOLUTION100017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-0807-04ML - Milliliter0338-0807c78fa55f-32d4-4d69-8076-4f831053b38f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROSE MONOHYDRATEACTIVE INGREDIENTLX22YL083GPOTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE (POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]7
POTASSIUM CHLORIDEACTIVE INGREDIENT660YQ98I10POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE (POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]7
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XPOTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE (POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]7
ANHYDROUS DEXTROSEACTIVE MOIETY5SL0G7R0OKPOTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE (POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]7
CHLORIDE IONACTIVE MOIETYQ32ZN48698POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE (POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]7
WATERINACTIVE INGREDIENT059QF0KO0RPOTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE (POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-0807POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE (POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]15Current NDC, Legacy NDC, 1 package rows20240910_c553fed1-3de5-4826-8eff-633b5923bf0b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1863975potassium chloride 10 MEQ / dextrose 5 % / sodium chloride 0.225 % in 500 ML InjectionPSNc553fed1-3de5-4826-8eff-633b5923bf0b17
1863607potassium chloride 10 MEQ / dextrose 5 % / sodium chloride 0.45 % in 500 ML InjectionPSNc553fed1-3de5-4826-8eff-633b5923bf0b17
630796potassium chloride 10 MEQ / dextrose 5 % / sodium chloride 0.45 % per 1000 ML InjectionPSNc553fed1-3de5-4826-8eff-633b5923bf0b17
1863973potassium chloride 20 MEQ / dextrose 5 % / sodium chloride 0.225 % in 1000 ML InjectionPSNc553fed1-3de5-4826-8eff-633b5923bf0b17
1863988potassium chloride 20 MEQ / dextrose 5 % / sodium chloride 0.3 % in 1000 ML InjectionPSNc553fed1-3de5-4826-8eff-633b5923bf0b17
1863605potassium chloride 20 MEQ / dextrose 5 % / sodium chloride 0.45 % in 1000 ML InjectionPSNc553fed1-3de5-4826-8eff-633b5923bf0b17
615107potassium chloride 20 MEQ / dextrose 5 % / sodium chloride 0.9 % in 1000 ML InjectionPSNc553fed1-3de5-4826-8eff-633b5923bf0b17
615099potassium chloride 30 MEQ / dextrose 5 % / sodium chloride 0.45 % in 1000 ML InjectionPSNc553fed1-3de5-4826-8eff-633b5923bf0b17
615100potassium chloride 40 MEQ / dextrose 5 % / sodium chloride 0.45 % in 1000 ML InjectionPSNc553fed1-3de5-4826-8eff-633b5923bf0b17
615111potassium chloride 40 MEQ / dextrose 5 % / sodium chloride 0.9 % in 1000 ML InjectionPSNc553fed1-3de5-4826-8eff-633b5923bf0b17
6307961000 ML glucose 50 MG/ML / potassium chloride 0.01 MEQ/ML / sodium chloride 4.5 MG/ML InjectionSCDc553fed1-3de5-4826-8eff-633b5923bf0b17
18639731000 ML glucose 50 MG/ML / potassium chloride 0.02 MEQ/ML / sodium chloride 2.25 MG/ML InjectionSCDc553fed1-3de5-4826-8eff-633b5923bf0b17
18639881000 ML glucose 50 MG/ML / potassium chloride 0.02 MEQ/ML / sodium chloride 3 MG/ML InjectionSCDc553fed1-3de5-4826-8eff-633b5923bf0b17
18636051000 ML glucose 50 MG/ML / potassium chloride 0.02 MEQ/ML / sodium chloride 4.5 MG/ML InjectionSCDc553fed1-3de5-4826-8eff-633b5923bf0b17
6151071000 ML glucose 50 MG/ML / potassium chloride 0.02 MEQ/ML / sodium chloride 9 MG/ML InjectionSCDc553fed1-3de5-4826-8eff-633b5923bf0b17
6150991000 ML glucose 50 MG/ML / potassium chloride 0.03 MEQ/ML / sodium chloride 4.5 MG/ML InjectionSCDc553fed1-3de5-4826-8eff-633b5923bf0b17
6151001000 ML glucose 50 MG/ML / potassium chloride 0.04 MEQ/ML / sodium chloride 4.5 MG/ML InjectionSCDc553fed1-3de5-4826-8eff-633b5923bf0b17
6151111000 ML glucose 50 MG/ML / potassium chloride 0.04 MEQ/ML / sodium chloride 9 MG/ML InjectionSCDc553fed1-3de5-4826-8eff-633b5923bf0b17
1863975500 ML glucose 50 MG/ML / potassium chloride 0.02 MEQ/ML / sodium chloride 2.25 MG/ML InjectionSCDc553fed1-3de5-4826-8eff-633b5923bf0b17
1863607500 ML glucose 50 MG/ML / potassium chloride 0.02 MEQ/ML / sodium chloride 4.5 MG/ML InjectionSCDc553fed1-3de5-4826-8eff-633b5923bf0b17
6307961000 ML Glucose 50 MG/ML / K+ Chloride 0.01 MEQ/ML / NaCl 4.5 MG/ML InjectionSYc553fed1-3de5-4826-8eff-633b5923bf0b17
18639731000 ML Glucose 50 MG/ML / K+ Chloride 0.02 MEQ/ML / NaCl 2.25 MG/ML InjectionSYc553fed1-3de5-4826-8eff-633b5923bf0b17
18639881000 ML Glucose 50 MG/ML / K+ Chloride 0.02 MEQ/ML / NaCl 3 MG/ML InjectionSYc553fed1-3de5-4826-8eff-633b5923bf0b17
18636051000 ML Glucose 50 MG/ML / K+ Chloride 0.02 MEQ/ML / NaCl 4.5 MG/ML InjectionSYc553fed1-3de5-4826-8eff-633b5923bf0b17
6151071000 ML Glucose 50 MG/ML / K+ Chloride 0.02 MEQ/ML / NaCl 9 MG/ML InjectionSYc553fed1-3de5-4826-8eff-633b5923bf0b17
6150991000 ML Glucose 50 MG/ML / K+ Chloride 0.03 MEQ/ML / NaCl 4.5 MG/ML InjectionSYc553fed1-3de5-4826-8eff-633b5923bf0b17
6151001000 ML Glucose 50 MG/ML / K+ Chloride 0.04 MEQ/ML / NaCl 4.5 MG/ML InjectionSYc553fed1-3de5-4826-8eff-633b5923bf0b17
6151111000 ML Glucose 50 MG/ML / K+ Chloride 0.04 MEQ/ML / NaCl 9 MG/ML InjectionSYc553fed1-3de5-4826-8eff-633b5923bf0b17
6307961000 ML Glucose 50 MG/ML / Pot Chloride 0.01 MEQ/ML / NaCl 4.5 MG/ML InjectionSYc553fed1-3de5-4826-8eff-633b5923bf0b17
18639731000 ML Glucose 50 MG/ML / Pot Chloride 0.02 MEQ/ML / NaCl 2.25 MG/ML InjectionSYc553fed1-3de5-4826-8eff-633b5923bf0b17
18639881000 ML Glucose 50 MG/ML / Pot Chloride 0.02 MEQ/ML / NaCl 3 MG/ML InjectionSYc553fed1-3de5-4826-8eff-633b5923bf0b17
18636051000 ML Glucose 50 MG/ML / Pot Chloride 0.02 MEQ/ML / NaCl 4.5 MG/ML InjectionSYc553fed1-3de5-4826-8eff-633b5923bf0b17
6151071000 ML Glucose 50 MG/ML / Pot Chloride 0.02 MEQ/ML / NaCl 9 MG/ML InjectionSYc553fed1-3de5-4826-8eff-633b5923bf0b17
6150991000 ML Glucose 50 MG/ML / Pot Chloride 0.03 MEQ/ML / NaCl 4.5 MG/ML InjectionSYc553fed1-3de5-4826-8eff-633b5923bf0b17
6151001000 ML Glucose 50 MG/ML / Pot Chloride 0.04 MEQ/ML / NaCl 4.5 MG/ML InjectionSYc553fed1-3de5-4826-8eff-633b5923bf0b17
6151111000 ML Glucose 50 MG/ML / Pot Chloride 0.04 MEQ/ML / NaCl 9 MG/ML InjectionSYc553fed1-3de5-4826-8eff-633b5923bf0b17
1863975500 ML Glucose 50 MG/ML / K+ Chloride 0.02 MEQ/ML / NaCl 2.25 MG/ML InjectionSYc553fed1-3de5-4826-8eff-633b5923bf0b17
1863607500 ML Glucose 50 MG/ML / K+ Chloride 0.02 MEQ/ML / NaCl 4.5 MG/ML InjectionSYc553fed1-3de5-4826-8eff-633b5923bf0b17
1863975500 ML Glucose 50 MG/ML / Pot Chloride 0.02 MEQ/ML / NaCl 2.25 MG/ML InjectionSYc553fed1-3de5-4826-8eff-633b5923bf0b17
1863607500 ML Glucose 50 MG/ML / Pot Chloride 0.02 MEQ/ML / NaCl 4.5 MG/ML InjectionSYc553fed1-3de5-4826-8eff-633b5923bf0b17
1863975potassium chloride 10 MEQ / dextrose 5 % / sodium chloride 0.225 % per 500 ML InjectionSYc553fed1-3de5-4826-8eff-633b5923bf0b17
630796potassium chloride 10 MEQ / dextrose 5 % / sodium chloride 0.45 % per 1000 ML InjectionSYc553fed1-3de5-4826-8eff-633b5923bf0b17
1863607potassium chloride 10 MEQ / dextrose 5 % / sodium chloride 0.45 % per 500 ML InjectionSYc553fed1-3de5-4826-8eff-633b5923bf0b17
1863973potassium chloride 20 MEQ / dextrose 5 % / sodium chloride 0.225 % per 1000 ML InjectionSYc553fed1-3de5-4826-8eff-633b5923bf0b17
1863988potassium chloride 20 MEQ / dextrose 5 % / sodium chloride 0.3 % per 1000 ML InjectionSYc553fed1-3de5-4826-8eff-633b5923bf0b17
1863605potassium chloride 20 MEQ / dextrose 5 % / sodium chloride 0.45 % per 1000 ML InjectionSYc553fed1-3de5-4826-8eff-633b5923bf0b17
615107potassium chloride 20 MEQ / dextrose 5 % / sodium chloride 0.9 % per 1000 ML InjectionSYc553fed1-3de5-4826-8eff-633b5923bf0b17
615099potassium chloride 30 MEQ / dextrose 5 % / sodium chloride 0.45 % per 1000 ML InjectionSYc553fed1-3de5-4826-8eff-633b5923bf0b17
615100potassium chloride 40 MEQ / dextrose 5 % / sodium chloride 0.45 % per 1000 ML InjectionSYc553fed1-3de5-4826-8eff-633b5923bf0b17
615111potassium chloride 40 MEQ / dextrose 5 % / sodium chloride 0.9 % per 1000 ML InjectionSYc553fed1-3de5-4826-8eff-633b5923bf0b17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0338-0807-04003380807041000 mL in 1 BAG (0338-0807-04) 1000 ml1985-04-050000-00-00NoNoCurrent