POTASSIUM CHLORIDE

Product NDC
72888-042
11-digit product format
728880042
Labeler code
72888
Product ID
72888-042_47c7720f-ffb0-0750-e063-6394a90a77c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
POTASSIUM CHLORIDE
Dosage form
SOLUTION
Route
ORAL
Labeler
Advagen Pharma Limited
Application
ANDA214656
Marketing category
ANDA
Marketing start
2022-01-13
Substance
POTASSIUM CHLORIDE
Active strength
40 meq/15mL
Pharmacologic classes
Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214656-001POTASSIUM CHLORIDEPOTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2022-01-13
A214656-002POTASSIUM CHLORIDEPOTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2022-01-13

Therapeutic equivalence codes#

Application-product, TE code table
Application-productTE code
A214656-001AA
A214656-002AA

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 CHLORIDEAdvagen Pharma Limiteda9e9d134-55d0-47ae-925f-de07e7ffa4b82026-01-07Warnings, 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 if administered undiluted. 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 Advagen Pharma Ltd, at 866-488-0312 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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM CHLORIDE40 meq/15mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii660YQ98I10
Rxcui312515, 314182

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
95250459-30e4-45c1-b08a-993044f49109Product name220250805
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72888-042-13POTASSIUM CHLORIDE473 mL in 1 BOTTLE, PLASTICSOLUTION4734

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-042-13ML - Milliliter72888-042a5598a52-3b3f-45a8-b38f-ff5f43f8320912023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-042POTASSIUM CHLORIDE SOLUTION [ADVAGEN PHARMA LIMITED]3Current NDC, Legacy NDC, 1 package rows20231228_a9e9d134-55d0-47ae-925f-de07e7ffa4b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312515potassium chloride 20 MEQ in 15 mL Oral SolutionPSNa9e9d134-55d0-47ae-925f-de07e7ffa4b84
314182potassium chloride 40 MEQ in 15 mL Oral SolutionPSNa9e9d134-55d0-47ae-925f-de07e7ffa4b84
312515potassium chloride 1.33 MEQ/ML Oral SolutionSCDa9e9d134-55d0-47ae-925f-de07e7ffa4b84
314182potassium chloride 2.67 MEQ/ML Oral SolutionSCDa9e9d134-55d0-47ae-925f-de07e7ffa4b84
312515K+ Chloride 1.33 MEQ/ML Oral SolutionSYa9e9d134-55d0-47ae-925f-de07e7ffa4b84
314182K+ Chloride 2.67 MEQ/ML Oral SolutionSYa9e9d134-55d0-47ae-925f-de07e7ffa4b84
312515Pot Chloride 1.33 MEQ/ML Oral SolutionSYa9e9d134-55d0-47ae-925f-de07e7ffa4b84
314182Pot Chloride 2.67 MEQ/ML Oral SolutionSYa9e9d134-55d0-47ae-925f-de07e7ffa4b84
312515potassium chloride 1.5 GM per 15 ML Oral SolutionSYa9e9d134-55d0-47ae-925f-de07e7ffa4b84
312515potassium chloride 10 % Oral SolutionSYa9e9d134-55d0-47ae-925f-de07e7ffa4b84
314182potassium chloride 20 % Oral SolutionSYa9e9d134-55d0-47ae-925f-de07e7ffa4b84
312515potassium chloride 20 MEQ per 15 ML Oral SolutionSYa9e9d134-55d0-47ae-925f-de07e7ffa4b84
314182potassium chloride 20 MEQ per 30 ML Oral SolutionSYa9e9d134-55d0-47ae-925f-de07e7ffa4b84
314182potassium chloride 3 GM per 15 ML Oral SolutionSYa9e9d134-55d0-47ae-925f-de07e7ffa4b84
314182potassium chloride 40 MEQ per 15 ML Oral SolutionSYa9e9d134-55d0-47ae-925f-de07e7ffa4b84
312515potassium chloride 40 MEQ per 30 ML Oral SolutionSYa9e9d134-55d0-47ae-925f-de07e7ffa4b84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72888-042-1372888004213473 mL in 1 BOTTLE, PLASTIC (72888-042-13) 473 ml2022-01-130000-00-00NoNoCurrent