Home NDC 72888-024 Potassium Chloride
Product NDC 72888-024
11-digit product format 728880024
Labeler code 72888
Product ID 72888-024_4845b2d4-bed2-188b-e063-6294a90af30c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Potassium Chloride
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Advagen Pharma Limited
Application ANDA214108
Marketing category ANDA
Marketing start 2022-03-24
Substance POTASSIUM CHLORIDE
Active strength 1.5 g/1.58g
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214108-001 POTASSIUM CHLORIDE POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2022-03-24
Therapeutic equivalence codes# Application-product, TE code table Application-product TE code A214108-001 AA
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.
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 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 Ingredient Strength POTASSIUM CHLORIDE 1.5 g/1.58g
Harmonized Identifiers# Field, Values table Field Values Unii 660YQ98I10 Rxcui 1867544
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72888-024-06 Potassium Chloride 1.58 g in 1 POUCH POWDER, FOR SOLUTION 1.58 4 72888-024-07 Potassium Chloride 30 in 1 CARTON POWDER, FOR SOLUTION 30 4 72888-024-10 Potassium Chloride 100 in 1 CARTON POWDER, FOR SOLUTION 100 4 72888-024-43 Potassium Chloride 50 in 1 CARTON POWDER, FOR SOLUTION 50 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72888-024 POTASSIUM CHLORIDE POWDER, FOR SOLUTION [ADVAGEN PHARMA LIMITED] 3 Current NDC, Legacy NDC, 4 package rows 20230307_d528c0c1-b81f-4f7a-8518-e6911b23c3eb.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 72888-024-06 72888002406 1.58 g in 1 POUCH 1.58 g Historical 72888-024-07 72888002407 30 POUCH in 1 CARTON (72888-024-07) / 1.58 g in 1 POUCH (72888-024-06) 30 pouch 2022-03-24 0000-00-00 No No Current 72888-024-10 72888002410 100 POUCH in 1 CARTON (72888-024-10) / 1.58 g in 1 POUCH (72888-024-06) 100 pouch 2022-03-24 0000-00-00 No No Current 72888-024-43 72888002443 50 POUCH in 1 CARTON (72888-024-43) / 1.58 g in 1 POUCH (72888-024-06) 50 pouch 2022-10-10 No No Current