Potassium Chloride

Product NDC
81033-413
11-digit product format
810330413
Labeler code
81033
Product ID
81033-413_440dbe01-dea3-0833-e063-6394a90ab048
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Chloride
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Kesin Pharma Corporation
Application
ANDA211667
Marketing category
ANDA
Marketing start
2022-10-24
Substance
POTASSIUM CHLORIDE
Active strength
1.5 g/1.58g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211667-001POTASSIUM CHLORIDEPOTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2021-03-11

Therapeutic equivalence codes#

Application-product, TE code table
Application-productTE code
A211667-001AA

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Potassium ChloridePOTASSIUM CHLORIDEKesin Pharma Corporation440dcbbb-bb31-d3fd-e063-6294a90ab2f72025-09-01Warnings, Adverse reactionsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings and cautions

5 WARNINGS AND PRECAUTIONS Gastrointestinal Irritation: Dilute before use, take with meals (5.1) 5.1 Gastrointestinal Irritation May cause gastrointestinal irritation. Increased dilution of the solution and taking with meals may reduce gastrointestinal irritation. [see Dosage and Administration (2.1)]

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

6 ADVERSE REACTIONS The most common adverse reactions to oral potassium salts are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea. Most common adverse reactions are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea (6) To report SUSPECTED ADVERSE REACTIONS, contact Kesin Pharma at 1-833-537-4679 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Additional Listing Data#

Finished product
Yes
Brand name base
Potassium Chloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM CHLORIDE1.5 g/1.58g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii660YQ98I10
Rxcui1867544

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
81033-413-01Potassium Chloride100 in 1 CARTONPOWDER, FOR SOLUTION1001
81033-413-20Potassium Chloride1.58 g in 1 POUCHPOWDER, FOR SOLUTION1.581

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1867544potassium chloride 20 MEQ (1.5 GM) Powder for Oral SolutionPSN440dcbbb-bb31-d3fd-e063-6294a90ab2f71
1867544potassium chloride 20 MEQ Powder for Oral SolutionSCD440dcbbb-bb31-d3fd-e063-6294a90ab2f71
1867544K+ Chloride 20 MEQ Powder for Oral SolutionSY440dcbbb-bb31-d3fd-e063-6294a90ab2f71
1867544Pot Chloride 20 MEQ Powder for Oral SolutionSY440dcbbb-bb31-d3fd-e063-6294a90ab2f71
1867544potassium chloride 1.5 GM Powder for Oral SolutionSY440dcbbb-bb31-d3fd-e063-6294a90ab2f71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81033-413-0181033041301100 POUCH in 1 CARTON (81033-413-01) / 1.58 g in 1 POUCH (81033-413-20) 100 pouch2025-09-01NoNoCurrent
81033-413-20810330413201.58 g in 1 POUCH1.58 gHistorical