Potassium Chloride for Oral Solution

Product NDC
10135-807
11-digit product format
101350807
Labeler code
10135
Product ID
10135-807_3e8a7f18-164c-7766-e063-6394a90acbca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Chloride for Oral Solution
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Marlex Pharmaceuticals, Inc.
Application
ANDA212183
Marketing category
ANDA
Marketing start
2025-08-01
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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
660YQ98I10POTASSIUM CHLORIDE7447-40-7POTASSIUM CHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10135-807-1310135080713100 POUCH in 1 CARTON (10135-807-13) / 1.58 g in 1 POUCH (10135-807-11) 100 pouch2025-08-01NoNoHistorical
10135-807-151013508071530 POUCH in 1 CARTON (10135-807-15) / 1.58 g in 1 POUCH (10135-807-11) 30 pouch2025-08-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Potassium Chloride for Oral SolutionMarlex Pharmaceuticals, Inc.2025-08-01HUMAN PRESCRIPTION DRUG LABEL1